Ewma Journal 2015, April Issue

Volume 15 Number 1 April 2015 Published by European Wound Management Association

TECHNOLOGIES

LEADING TO

CHANGE WHERE WILL IT TAKE US?

The EWMA Journal ISSN number: 1609-2759 Volume 15, No 1, April, 2015 The Journal of the European Wound Management Association Published twice a year

EWMA Council Salla Seppänen President

Jan Apelqvist

Immediate Past President

Severin Läuchli President Elect

Editorial Board Sue Bale, UK, Editor Salla Seppänen, Finland Georgina Gethin, Ireland Martin Koschnick, Germany Rytis Rimdeika, Lithuania José Verdú Soriano, Spain Luc Gryson

Dubravko Huljev

José Verdú Soriano

Sue Bale

Mark Collier

Ann-Mari Fagerdahl

Georgina Gethin

Arkadiusz Jawien

Edward Jude

Treasurer

Secretary

Scientific Recorder

EWMA web site www.ewma.org Editorial Office please contact: EWMA Secretariat Nordre Fasanvej 113 2000 Frederiksberg, Denmark Tel: (+45) 7020 0305 Fax: (+45) 7020 0315 ewma@ewma.org

EWMA Journal Editor

Magdalena Annersten Gershater

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Gerrolt Jukema

Martin Koschnick

Knut Kröger

Printed by: Kailow Graphic, Denmark Copies printed: 9.000 Prices: The EWMA Journal is distributed in hard copies to members as part of their EWMA membership.

EWMA also shares the vision of an “open access” philosophy, which means that the journal is freely available online.

Individual subscription per issue: 7.50€ Libraries and institutions per issue: 25€ The next issue will be published in October 2015. Prospective material for publication must be with the EWMA Secretariat as soon as possible and no later than June 15th 2015.

The contents of articles and letters in EWMA Journal do not necessarily reflect the opinions of the Editors or the European Wound Management Association.

All scientific articles are peer reviewed by EWMA Scientific Review Panel.

Copyright of published material and illustrations is the property of the European Wound Management Association. However, provided prior written consent for their reproduction, including parallel publishing (e.g. via repository), obtained from EWMA via the Editorial Board of the Journal, and proper acknowledgement, such permission will normally be readily granted. Requests to reproduce material should state where material is to be published, and, if it is abstracted, summarised, or abbreviated, then the proposed new text should be sent to the EWMA Journal Editor for final approval.

All issues of EWMA Journal are CINAHL listed.

2

Alberto Piaggesi

Rytis Rimdeika

Andrea Pokorná

Robert Strohal

COOPERATING ORGANISATIONS’ BOARD Esther Armans Moreno, AEEVH Christian Thyse, AFISCeP.be Massimo Rivolo, AISLeC Corrado Maria Durante, AIUC Ana-Maria Iuonut, AMP Romania Aníbal Justiniano, APTFeridas Gilbert Hämmerle, AWA Kirsty Mahoney, AWTVNF Jan Vandeputte, BEFEWO Vladislav Hristov, BWA Els Jonckheere, CNC Lenka Veverková, CSLR Mirela Bulic, CWA Arne Buss, DGfW Anette Norden, DSFS Heidi Castrén, FWCS Rosa Nascimento, GAIF

J. Javier Soldevilla, GNEAUPP Georgios Vasilopoulos, HSWH Christian Münter, ICW Aleksandra Kuspelo, LBAA Susan Knight, LUF Loreta Pilipaityte, LWMA Corinne Ward, MASC Hunyadi János, MSKT Suzana Nikolovska, MWMA Linda Primmer, NATVNS Øystein Karlsen, NIFS Louk van Doorn, NOVW Arkadiusz Jawie´n, PWMA Sebastian Probst, SAfW (DE) Maria Iakova, SAfW (FR) Goran D. Lazovic, SAWMA Tania Asantos, ELCOS

Jan Stryja

Hubert Vuagnat

Ján Koller, SSPLR Mária Hok, SEBINKO F. Xavier Santos Heredero, SEHER Sylvie Meaume, SFFPC Susanne Dufva, SSIS Jozefa Košková, SSOOR Leonid Rubanov, STW (Belarus) Guðbjörg Pálsdóttir, SUMS Cedomir Vucetic, SWHS Serbia Magnus Löndahl, SWHS Sweden Tina Chambers, TVS Jasmina Begi´c-Rahi´c, URuBiH Natalia Vasylenko, UWTO Barbara E. den Boogert-Ruimschotel, V&VN Caroline McIntosh, WMAI Skender Zatriqi, WMAK Dragica Tomc, WMAS Mustafa Deveci, WMAT

EWMA JOURNAL SCIENTIFIC REVIEW PANEL Paulo Jorge Pereira Alves, Portugal Caroline Amery, UK Jan Apelqvist, Sweden Sue Bale, UK Michelle Briggs, UK Stephen Britland, UK Mark Collier, UK Rose Cooper, UK Javorka Delic, Serbia Corrado Durante, Italy Bulent Erdogan, Turkey Ann-Mari Fagerdahl, Sweden Madeleine Flanagan, UK Milada Francu˚, Czech Republic Peter Franks, UK Francisco P. García-Fernández, Spain Magdalena Annersten Gershater, Sweden

Georgina Gethin, Ireland Luc Gryson, Belgium Marcus Gürgen, Norway Eskild W. Henneberg, Denmark Alison Hopkins, UK Gabriela Hösl, Austria Dubravko Huljev, Croatia Arkadiusz Jawien, Poland Gerrolt Jukema, Netherlands Nada Kecelj, Slovenia Klaus Kirketerp-Møller, Denmark Zoltán Kökény, Hungary Martin Koschnick, Germany Knut Kröger, Germany Severin Läuchli, Schwitzerland Maarten J. Lubbers, Netherlands Sylvie Meaume, France

Zena Moore, Ireland Christian Münter, Germany Andrea Nelson, UK Pedro L. Pancorbo-Hidalgo, Spain Hugo Partsch, Austria Patricia Price, UK Sebastian Probst, Schwitzerland Elia Ricci, Italy Rytis Rimdeika, Lithuania Zbigniew Rybak, Poland Salla Seppänen, Finland José Verdú Soriano, Spain Robert Strohal, Austria Richard White, UK Carolyn Wyndham-White, Switzerland Gerald Zöch, Austria

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6 Editorial

Science, Practice and Education 8 Efficacy of magnetic resonance imaging in deciding the appropriate surgical margin in diabetic foot osteomyelitis. Fujii M, Armstrong DG, Terashi H 15 Ex vivo platelet activation with extended duration pulse electric fields for autologous platelet gel applications - A new, potential clinical standard for platelet activation and perspectives for a more widespread adoption and improved wound healing with platelet gels. Neculaes VB, Torres A, Morton C, Larriera A, Klopman S, Conway K, Garner AL 21 Pressure ulcer reduction: the role of unregistered healthcare support workers in validation and prevention. Ellis MB, Price J 27 Measuring change in limb volume to evaluate lymphoedema treatment outcome. Williams AF, Whitaker J

Scientific Communication 35

42

47

54 61

65 71

Emerging targeted technology to address unmet clinical needs - Implementing a development and adoption strategy. Vowden P Great opportunities ahead! Don’t miss the boat! Where tech meets health care. Reig J, Valverde JA, Reig M A patient-led approach to product innovation in patient education and wound management. McNichol E, McKay A, Milligan C, Bennett K, Hulme R, Joy H European perspectives on biomaterials for health. Donnelly F An eLearning modular approach to pressure Ulcer prevention and management: the views of nursing staff. Cameron R, Rodgers A, Welsh L, McGown K Major and minor amputation rates: What do they tell us?. Kröger K Wound risk and prevention in obesity: The role of nutrition Ballesteros-Pomar MD

25th Conference of the European Wound Management Association

EWMA 2015 LONDON · UK 13 -15 MAY 2015 WOUND CARE – SHAPING THE FUTURE A PATIENT, PROFESSIONAL, PROVIDER AND PAYER PERSPECTIVE

Cochrane Reviews 77 Abstracts of recent cochrane reviews. Bell-Syer S

EWMA 84 EWMA Journal previous issues and other journals 86 EWMA 2015 Conference in London, UK, José Verdú Soriano 88 Promoting antimicrobial stewardship in wound care 91 eHealth in wound care - overview and key issues to consider before implementation. Moore Z 93 EWMA news 97 Report from the 6th Pisa International Diabetic Foot Course 2014 Piaggesi A 98 The woundcare kit - a key tool for wound Care in a humanitarian Environment. Vuagnat H, Comte E 100 Obituary notice

Organisations 101 AWMA news. Asimus M, Andrews J 102 AAWC news. Driver VR 103 Response to the challenges of chronic wound diseases: CTRS’s action 104 ELCOS - Portuguese Wound Society - an innovative approach Furtado K, Santos T 106 Slovak Wound Healing Society (SSPLR). Koller J 108 Hellenic Society of Wound Healing (HSWH). Koulermou G 109 Conference calendar 110 Cooperating Organisations

WWW.EWMA2015.ORG WWW.EWMA.ORG WWW.TVS.ORG.UK 5

Editorial

New technologies improving wound care?

T

he title of the AEWM 2015 Conference in London is Wound Care – Shaping the Future: a Patient, Professional, Provider, and Payer perspective. The conference focuses on the barriers and challenges, as well as the opportunities that decision makers, clinicians, and patients face in the modern healthcare systems. The demand for efficient and cost-effective use of resources to optimise wound care is rising as governments in the European countries race to cut costs, while maintaining quality of care and improving treatment outcomes.

These developments influence all health care stakeholders, from patient to policy maker, and they demand innovative procedures and practices, as well as interdisciplinary teamwork and collaboration.

An important part of the equation is the opportunities posed by the technological advancements made in wound care and the organisation of care, and the innovations that lie ahead. Thus, in this issue of the EWMA Journal, we focus on new technology and methods that drive innovation within wound care.

On page 8, Miki Fujii et al. explore the efficacy of using MRI for deciding the appropriate surgical margin in diabetic foot osteomyelitis, and on page 15, Vasile Bogdan Neculaes et al. introduce a newly developed instrumentbased method for ex vivo platelet activation via extendedduration electrical pulses. Both articles deal with a new application of existing methods or technology, and could be seen as examples of incremental innovation, which is defined by building on, and improving current practices.

The different types of innovation, as well as development and adoption strategy in a health care context, are explored further in the article by Peter Vowden on page 35. An example of an innovation process, with the patient as a pivotal point, is presented in the article by Elaine McNichol on page 47, and Juan Reig provides a look to the future, outlining perspectives on the possible technological developments in health care, in his article on page 42.

EWMA AS A DRIVER OF INNOVATION AND TECHNOLOGICAL DEVELOPMENTS EWMA continuously works to be on the forefront of the developments and innovations in wound care, and does so through a number of initiatives and activities. At the EWMA 2015 conference in London, European and

6

American key opinion leaders from academia, associations, and industry will meet for an expert forum to discuss and share knowledge about present and future developments in advanced wound care. EWMA is presently also engaged in several EU directed development projects following the Commission’s wish to strengthen the collaboration between academia and industry.

As part of EWMA’s advocacy initiatives to actively shape the eHealth developments within wound care in the EU, EWMA is a partner in the EU supported United4Health project (www.united4health.eu). This project aims to support large-scale deployment of eHealth solutions, and a key task of EWMA within this project is to highlight the role of healthcare providers in the successful implementation of eHealth and telemedicine solutions in clinical practice.

As an important part of EWMA’s engagement in United4Health, EWMA has produced a document providing a structured overview of the key issues related to use of eHealth applications within wound care. The document entitled, “eHealth in Wound Care – Overview and Key Issues to Consider Before Implementation” has been developed in collaboration with the Australian Wound Management Association, and will be published by the Journal of Woundcare in May 2015. You can read a summary of this document on page 91.

As another United4Health activity, EWMA will host a full day symposium on eHealth at the EWMA conference in London, on Friday 15 May. The symposium programme is introduced on page 92.

WHY TECHNOLOGY? An important question to ask in relation to the increased use and rapid developments within wound care technology and eHealth is who will benefit from the developments?

This is a key focus point for this year’s congress. The patient should be the major beneficiary of new developments, but are we sure that this is always the case? Too often, we see projects with great potential for improving the quality of life for patients being ‘turned down’ due to too few economic benefits for the system. EWMA always aims to not only be the voice of the wound care professionals and their associations, but also to ensure that our work focuses on the patient’s best interest as a cardinal point.

Salla Seppänen, EWMA President Sue Bale, Editor of EWMA Journal EWMA Journal

2015 vol 15 no 1

Miki Fujii, MD, PhD1

David G. Armstrong, DPM, MD, PhD2,

Efficacy of magnetic resonance imaging in deciding the appropriate surgical margin in diabetic foot osteomyelitis ABSTRACT The best therapy for diabetic foot osteomyelitis (DFO) is controversial. However, identification of the precise localization of DFO is essential for appropriate treatment.

AIM To ascertain the efficacy of magnetic resonance imaging (MRI) in the diagnosis of DFO, and to select the appropriate surgical margin.

Hiroto Terashi, MD, PhD3

1Department

of Plastic and Reconstructive Surgery, Kitaharima Medical Center, Ono, Japan

2Southern Arizona Limb Salvage Alliance, University of Arizona College of Medicine, Tucson, AZ, USA 3Department

of Plastic and Reconstructive Surgery, Kobe University Hospital, Kobe, Japan Correspondence to: mikidtma@gmail.com

Conflicts of interest: None

METHODS Preoperative MRI findings were compared with the results of histopathological examinations of resected bones, and the margins of the resected bones were analysed by histopathology. A total 149 bones from 28 foot ulcers in 26 patients were examined. All ulcers were classified into 4 types according to the main etiological factors.

RESULTS In 14 neuropathic ulcers, all 55 bones, even those with severe infection, were fully and accurately diagnosed with the use of MRI. In 14 ischemic ulcers, only 9 of 94 bones evaluated by MRI after revascularization were diagnosed accurately. Of 32 bone margins that showed bone marrow oedema, 28 healed, and 4 did not heal, displaying severe infection or ischemia.

CONCLUSIONS MRI is effective in the diagnosis of neuropathic ulcers, but not as effective in the diagnosis of ischemic ulcers. This study suggested that the appropriate surgical margin should be defined in the area of the bone marrow oedema, but diligence should be exercised in cases with severe infection or ischemia.

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INTRODUCTION The best therapy for diabetic foot osteomyelitis (DFO), whether primarily medical or primarily surgical, is a subject of contention. Each has its potential advantages and disadvantages1. Recent guidelines2 have recommended that the presence and amount of residual dead or infected bone and soft tissue should determine the duration of antibiotic therapy. Besides the choice of primary therapy, identification of the precise localization of DFO is essential for appropriate treatment.

Guidelines2,3 recommend the use of plain radiographs as a first-line investigative tool for diagnosing DFO, and further note that although magnetic resonance imaging (MRI) has been recognized as the most accurate imaging modality for detecting DFO, it is not always necessary for diagnosing or managing DFO. Plain radiographs, however, show only destruction of bone, and not actual bone infection or inflammation.

We have previously demonstrated the efficacy of MRI in the diagnosis of DFO in ulcers with different aetiologies 4,5. In the present report, we describe our study of additional cases, and propose a means of defining the appropriate surgical margin for remission based on MRI and histopathological findings.

METHODS First, preoperative MRI findings were compared with the results of histopathological examination of the resected bones. Second, bone margins of the resected bones were analysed by histopathology.

The records of 26 patients with diabetic foot ulcers (20 men and 6 women; mean age, 66.8 years; range, 42−85 years of age) who were suspected of having osteomyelitis and had undergone surgery from 2008−2014 were examined. All patients had been diagnosed with type 2 diabetes, according to the classification of the World Health Organization.

The ulcers were classified into 4 types according to the main aetiological factors: type I, neuropathic ulcers; type II, ischemic ulcers (critical limb ischemia [CLI]); type III, neuropathic ulcers with infection; and type IV, ischemic EWMA Journal

2015 vol 15 no 1

Science, Practice and Education

ulcers with infection4-6. Peripheral neuropathy (PN) was assessed by touch sensation using the Ipswich touch test7.

Peripheral arterial disease (PAD) was suspected by the absence of pulsation and/or sound from the dorsalis pedis artery and the posterior tibial artery assessed by Doppler stethoscope, an ankle-brachial index < 0.9, and skin perfusion pressure < 40 mmHg. Patients with suspected PAD were evaluated with the use of computed tomographic angiography, duplex ultrasonography, and angiography.

Infection was assessed by the following: general conditions such as high fever, chills, or malaise; clinical findings such as redness, warmth, swelling, or purulent secretions; the results of laboratory tests. DFO was suspected in patients with a positive probe-to-bone test, swollen foot, sausage toe, unexplained high leukocyte count or inflammatory markers, and plain foot radiographic findings3.

Preoperative MRI was carried out with 1.5 T MR scanners (3 mm slice thickness, T1-weighted images, conventional spin echo, repetition time/echo time of 460 ms/13 ms, fat-suppressed T2-weighted images, short-tau inversion-recovery images, short T1 inversion recovery, and repetition time/echo time/inversion time of 3,401 ms/80 ms/150 ms). All MRI findings were checked by M.F and H.T with consensus interpretation. The affected bone marrow was compared with the adjacent normal fatty marrow, and low intensity signals on T1-weighted images and high intensity signals on fat-suppressed T2-weighted images were attributed to osteomyelitis. Incomplete or hazy signals or reticulated patterns were attributed to reactive bone marrow oedema. Normal bone marrow signals were considered indicative of areas clear of disease (8). All bones were marked according to the presence of osteomyelitis (OM), bone marrow oedema (BME), or normal bone (N) (Fig. 1).

Surgery after the MRI diagnosis included resection of Figure 1: MRI diagnosis of case 1, left 2nd toe b)

b)

C)

a)

a)

b) c)

c)

b) c)

a) Osteomyelitis (OM) (T1WI: low intensity, fat-suppressed; T2WI: high intensity) b) Bone marrow edema (BME) (incomplete or hazy signals or reticulated patterns) c) Normal bone marrow signal (N) MRI diagnosis: Distal phalanges (c): Normal bone (N) Middle phalanges (b, a): bone marrow edema/ osteomyelitis (BME/ OM) Proximal phalanges (a, b, c): osteomyelitis/bone marrow edema/ normal bone (OM/BME/N)

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2015 vol 15 no 1

the infected bones and gangrenous tissue, amputation, or disarticulation. The area of resection was estimated preoperatively (from the MRI findings, blood flow, and area of soft tissue infection) and confirmed intraoperatively.

A definitive diagnosis was then made from the histopathological examination of 5 mm thick sections of formalinfixed and paraffin-embedded bones stained with haematoxylin and eosin. Only bone marrow oedema or infiltration of inflammatory cells, or both was considered indicative of reactive bone marrow oedema. However, these 2 conditions, together with the presence of osteonecrosis, granulation tissue, and/or fibrosis, were considered indicative of osteomyelitis (Fig. 2). The diagnosis from the preoperative MRI findings was compared with the definitive diagnosis from the histopathological findings (Fig. 3).

Bone margins of the resected bones were examined by histopathology.

Figure 2: Histopathological diagnosis (haematoxylin & eosin staining, 40×) Osteomyelitis (OM)

Bone marrow edema (BME)

(H&E; 40 )

Bone marrow edema Inflammatory cells Osteonecrosis Granulation Fibrosis

(H&E; 40 )

Bone marrow edema Inflammatory cells

Informed consent was obtained from each patient, and the study protocol conformed to the ethical guidelines of the Declaration of Helsinki as reflected in the approval by the institution’s human research review committee.

RESULTS A total of 28 ulcers from 26 patients, including 2 patients with 2 different types of ulcers each, were classified into 4 types according to the main aetiological factors as follows: type I, neuropathic ulcers (n=3); type II, ischemic ulcers (n=3); type III, neuropathic ulcers with infection (n=11); and type IV, ischemic ulcers with infection (n=11) (Table 1).

The 26 patients underwent a total of 30 MRI examinations before surgery (Table 2). The average interval between the MRI examinations and surgery was 16.7 (range 2−48) days. All ischemic ulcers (type II and type IV) were revascularised by bypass or endovascular treatment before surgery. MRI was carried out as follows: 3 examinations for 3 type I ulcers; 3 before revascularisation for 3 type II ulcers; 1 after revascularisation for 1 type II ulcers; 11 for 9



Figure 3: Histopathological diagnosis of case 1, left 2nd toe.

OM N

BME)

OM)

BME

BME)

N)

N)

BME

Histopathological features of bone marrow in the resected bones correspond to the MRI findings.

Table 1. Classification of ulcers

OM

Main aetiologic factors Classification* Ulcers (n) Neuropathic ulcers Type I 3** Ischemic ulcers ( CLI ) Type II 3** Neuropathic ulcers Type III 11** ½ (H&E; 40 ) with infection CLI with infection Type IV 11** Total

28** *Terashi H. et al Keio Osteomyelitis J Med 2011; 6 0:17-­‐21, * *Two (OM), bone marrow edema (BME), normal marrow (N) patients, had two types obone f ulcers each.

N different

OM

Table Table 1 1. . C Classification lassification o of f u ulcers lcers

Table 2. Details of MRI examinations

Main aaetiologic etiologic ffactors actors Classification* Classification* Ulcers Ulcers ((n) n) Main Neuropathic u lcers

Type I

3** Neuropathic ulcers Type I 3** Ischemic u lcers (

C LI )

Type I I 3** Ischemic ulcers ( CLI ) Type II 3** Neuropathic u lcers

Type I II 11** ½ Neuropathic ulcers Type III 11** ½ with i nfection with infection CLI 11** CLI w with ith iinfection nfection Type Type IIV V 11** Total

28** Total

28** *Terashi H . e t a l

K eio J

M ed 2 011; 6 0:17-­‐21, * *Two *Terashi H. et al Keio J Med 2011; 60:17-­‐21, **Two patients, h had ad ttwo wo d different ifferent ttypes ypes o of f u ulcers lcers eeach. ach. patients,

Type I Type II

MRI 3* 4* Pre-­‐revascularization: 3 Post-­‐revascularization: 1 Type III 11 11* Type IV 11 12* Pre-­‐revascularization: 6

Post-­‐revascularization: 6 Total 28 30* Average interval between MRI and surgery: 16.7 days. *One ulcer of Type II (Case 5) underwent both pre-­‐ and post-­‐ revascularization MRI.

Table Table 2 2. . D Details etails o of f M MRI RI e examinations xaminations

11 type III ulcers; and 6 before and 6 after revascularisation

Ulcers MRI

MRI post-revascularisation for type IV Ulcers ulcers. Pre- and MRI Type I

3

3*

Type I for 23 patients who 3* underwent

was done 2 surgeries, 1 for Type 3 4* Type III I 3 4* Pre-­‐revascularization: Pre-­‐revascularization: 3 3 type II ulcer and 1 for type IV ulcer.

Post-­‐revascularization: Post-­‐revascularization: 1 1 A total of 149 bone specimens (39 distal phalanx, 29 Type I II 11

11*

Type III 11 11* Type

11 12* Pre-­‐revascularization: 6 middle 34 metatarsal bone, Type IIV V phalanx, 11 46 proximal 12* phalanx, Pre-­‐revascularization: 6

Post-­‐revascularization: 6 and from 57 toes as follows: 1 cuboid bone were obtained Post-­‐revascularization: 6 Total 28

30*

Total 28 from 3 ulcers), 30* type II (40 bones from 3 type I (11 bones Average iinterval b etween M RI a nd ssurgery: 1 d Average nterval b etween M RI a nd urgery: 16.7 6.7 and days. ays. ulcers), typeof III (44II (bones from 11 ulcers), typeost-­‐ IV *One u lcer T ype Case 5 ) u nderwent b oth p re-­‐ *One ulcer of Type II (Case 5) underwent both pre-­‐ aand nd p post-­‐ (54 bones from 11 ulcers) (Table 3). revascularization revascularization M MRI. RI. Histologic analysis of all bone specimens revealed the

Table Table 3 3: : SSpecification pecification o of f b bone one sspecimens pecimens iin n e each ach u ulcer lcer ttype ype Ulcers Ulcers (n) Toes ((n) n)

(n) Toes Type I

3

4* Type I 3

4* Type I I 3

12* Type II 3

12* Type I II 11

19* Type III 11

19* Type I V 11

22* Type IV 11

22* Total 28

57* Total 28

57* *Four t oes a nd a

c uboid bone one *Four toes and a cuboid b

10

Bones Bones ((n) n) 11 11 40 40 44 44 54 54 149 149

Distal Distal phalanx phalanx ((n) n) 3 3 12 12 13 13 11 11 39 39

Ulcers 3 3

presence of osteomyelitis, bone marrow oedema, normal

bone, or gangrene. The histopathological features of bone Table 3: in Specification of bbones one specimens in each ype marrow the resected corresponded toulcer the tMRI findings for ulcers of types I and III in every localisationMiddle (Table 4). Osteomyelitis was detected in 41 bones, Ulcers Distal withphalanx

(n) specificity Toes (n) of Bones phalanx (n) (n) a sensitivity and 100%.(n) In type II ulcers, Type I

3

4*

11

3

however, none of the 40 bones was accurately diagnosed 3 Type II because 3 of unclear 12* or equivocal 40 12 (Table 9 by MRI images Type III 11

19* 44 13 5). Of 40 bones from type II ulcers, 27 showed dry gan- 7 Type IV 11

22* 54 11 10 grene.

Only28 9 bones from type149 IV ulcers examined by 29 Total

57*

39 post-revascularisation *Four toes and a cuboid MRI bone were accurately diagnosed.

Middle Middle phalanx

phalanx (n) (n) 3 3 9 9 7 7 10 10 29 29

Proximal Proximal phalanx phalanx Metatarsal Metatarsal (n) (n) (n) (n) 3

1 3 1 11

8 11 8 14

10 14 10 18

15 18 15 46

34 46 34

Cuboid Cuboid (n) (n) 1 1

1 1

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2015 vol 15 no 1

Science, Practice and Education

Table 4. MRI and histopathological diagnosis of neuropathic ulcers (Type I; Neuropathic ulcers, Type III; neuropathic ulcers with infection)

MRI diagnosis (n) Histopathological diagnosis (n) Type Ulcers(n) Bones(n) Correct Incorrect OM OM/BME OM/BME/N BME I

3

11

11 0 6 4 0 1 III 11

44

44 0 17 12 2 10 Total 14

55

55 0

Osteomyelitis (OM), bone marrow edema (BME), normal bone (N)

N 0 3

The other 45 bones still could not be diagnosed because clinical outcomes of nonsurgical treatments have been of unclear or equivocal images. demonstrated with long-term courses of antibiotics2. If conservative surgery is chosen, the surgeon needs to know Histopathological analysis revealed osteomyelitis in 27 bones of type IV ulcers, but only 9 bones were correctly the precise area of osteomyelitis. If medical therapy were Table 5. MRI nd histopathological diagnosis ischemic ulcers (CLI) chosen, the duration of antibiotic therapy would depend diagnosed byapost-revascularisation MRI,of with a sensitiv(Type II; CLI, Type IV; CLI with infection) ity of 29.6%. on the presence and amount of residual dead or infected Margins of 49 bones wereGroup examined by histopathology bone2. Besides choosing primary therapy, identification of A; Pre-­‐revascularization MRI diagnosis

(Table 6). Of 37 bone margins of healed ulcers, 9 were the precise localization of DFO is therefore essential for

MRI d iagnosis

Histopathological diagnosis

normal and 28 displayed bone marrow oedema. Of 12 appropriate treatment.

OM/ OM/ bone margins of unhealed ulcers, 4 showed bone marrow MRI is a valuable tool for diagnosing osteomyelitis, Type Ulcers Bones Correct Incorrect* OM BME BME/N OM/G BME BME/N G N oedema and II 3** 8 were 33 gangrenous.

0 Of the 33 32 bone 4 margins 0 0 as well as 0 for defining 1 the 1 presence

27 and 0 anatomy of deep 3 with marrow the 4 0 soft displaying IV bone 5** 14 oedema,

0 28 healed 14 (87.5%)

3 and 5 tissue 1 infections 2 . Its2 efficacy

1 in accurately 0

that did not heal were from 2 patients with type III ulcers the extent of DFO of different aetiological types of ulcers Table 4. MTable Table RI and 44. . hM M istopathological RI RI aand nd hhistopathological istopathological diagnosis dodiagnosis oof f nneuropathic europathic ulcers uulcers lcers involving severe soft tissue infection and f iagnosis 2neuropathic patients with is not definitively known. Our previous studies4,5 have Group Post-­‐revascularization MRI iagnosis (Type I; Neuropathic (Type (Type II; ; NNeuropathic europathic ulcers, Type uulcers, lcers, III; nBeuropathic TT; ype ype IIII; II; nneuropathic europathic ulcers with uulcers ilcers nfection) w wdith ith iinfection) nfection) type IV ulcers involving severe soft tissue infection and demonstrated the efficacy of MRI in diagnosing DFO

ischemia.

8 gangrenous bone margins from of different aetiological types of ulcers, showing that for

dMRI diagnosis MRI MRI d(dn) iagnosis iagnosis (Histopathological (n) n) Histopathological Histopathological diagnosis iagnosis iagnosis n) The MRI iagnosis 2 patients dHistopathological iagnosis d(dn) ((n)

Type type Type Ulcers(n) Type Ulcers(n) Ulcers(n) Bones(n) Bones(n) Bones(n) Correct Correct Correct Incorrect Incorrect OM OM/ OM/BME OM OM OM/BME OM/BME OM/BME/N OM/BME/N OM/BME/N BME I, III), BME BME N DFO N N was reliably disOM/ with II ulcers could not be diagnosed

by MRIIncorrect because neuropathic ulcers (type I Ulcers I I 3 Bones 3 3 11 11 11 11

11 11 0 OM BME 0 0 6 BME/N tinguishable 6 6 4 OM/G

4 4 0 from

0 0 BME/N 1 bone 0 1 1 oedema N 0 0 at any location, Correct Incorrect* BME G ofType severe ischemia. reactive 11 III III 7 11 11 44 44 44 7 44 44 0 0 0 0 17 0 17 17 12 12 2 4 2 2 10 2 3 10 10 0 1 3 3 II III 1** 44 0 0 12 in the presence of severe infection.

Total 6** Total Total 14 40 14 14 55 55 55 -­‐ 55 55 0 1 0 0 1 even 0 However, MRI IV 55 9 6 0 1 0 0 useful in1 diagnosing Osteomyelitis Osteomyelitis Osteomyelitis b one OM), marrow b-­‐ bone one m marrow arrow (BME), eedema dema (12 (BME), BME), bone n4 normal ormal ( N) bbone one ( (N) N) not 3

(OM),

((OM), edema 31 normal 1 was

1 ischemic 9 0 ulcers (type II, IV)

DISCUSSION because Osteomyelitis (OM), Bone marrow edema (BME), Normal bone (N), Gangrene (G) of insufficient interstitial fluid. Taken together, our *Because of unclear equivocal MRI findings, **One ulcer of Type II uprevious nderwent bconclusions oth pre-­‐ and phave ost-­‐ been confirmed by additional Positive results haveor been shown with conservative surgery vascularization

MRI. combined with antibiotics9,10, and additional satisfactory cases in the present study. 

Table 5. M RI and istopathological diagnosis dodiagnosis f iagnosis ischemic lcers (CLI)

Table Table 55. . h M M RI RI aand nd hhistopathological istopathological oof f uiischemic schemic uulcers lcers ((CLI) CLI) (Type II; CLI, Type with infection) (Type (Type III; I; CICV; LI, LI, C TLI Type ype IIV; V; CCLI LI w with ith iinfection) nfection) Group A; PGroup Group re-­‐revascularization AA; ; PPre-­‐revascularization re-­‐revascularization MRI diagnosis M MRI RI ddiagnosis iagnosis

Histopathological Histopathological iagnosis

Histopathological diagnosis ddiagnosis

OM/ OM/ OM/ OM/ OM/ OM/ Type Type Bones Ulcers Ulcers Correct Bones Bones Correct Correct Incorrect* OM OM BME/N BME BME BME/N BME/N OM/G BME/N BME BME BME/N BME/N G N N Type Ulcers Incorrect* Incorrect* OM BME OM/G OM/G BME G N G II 3** II II 33 3** 3** 33 33 0 0 0 33

33 4 33 0 4 4 0 0 0 0 0 0 1 0 0 1 1 1 27 1 1 0 27 27 0 0 IV 5** IV IV 14 5** 5** 14 14 0 0 0 14

14 3 14 5 3 3 0 5 5 0 0 1 2 1 1 2 2 2 1 2 2 0 1 1 0 0

MRI

MRI MRI ddiagnosis iagnosis diagnosis

Group B; PGroup Group ost-­‐revascularization BB; ; PPost-­‐revascularization ost-­‐revascularization MRI diagnosis M MRI RI ddiagnosis iagnosis Histopathological diagnosis ddiagnosis

Histopathological Histopathological iagnosis

OM/ OM/ OM/ OM/ OM/ OM/ Type Ulcers Incorrect* Incorrect* OM BME OM/G OM/G BME G N G Type Type Bones Ulcers Ulcers Correct Bones Bones Correct Correct Incorrect* OM OM BME/N BME BME BME/N BME/N OM/G BME/N BME BME BME/N BME/N G N N II 1** II II 1** 1** 7 7 7 0 0 0 7

7 0 7 0 0 0 0 0 0 0 0 0 4 0 0 2 4 4 0 2 2 1 0 0 1 1 IV 6** IV IV 40 6** 6** 40 40 9 9 9 -­‐

1 -­‐ -­‐ 6 1 1 1 6 6 1 1 0 1 0 0 0 1 1 0 0 0 0 0 0 0 0

-­‐ -­‐ -­‐ 31

31 12 31 4 12 12

1 4 4 1 1 3 1 3 3 1 1 1 9 1 1 0 9 9 0 0 Osteomyelitis Osteomyelitis Osteomyelitis (OM), Bone ((OM), OM), marrow BBone one edema m marrow arrow (BME), eedema dema Normal ((BME), BME), bone NNormal ormal (N), G bbone angrene one ((N), N), GG (G) angrene angrene ((G) G) *Because *Because o*Because f unclear ooof f r uuenclear quivocal RI findings, *f*One ulcer of Type II uoonderwent b oth pre-­‐ babnd ppost-­‐ nclear oor r eM equivocal quivocal M MRI RI findings, indings, ***One *One uulcer lcer f f TType ype III I uunderwent nderwent oth oth pre-­‐ re-­‐ aand nd ppost-­‐ ost-­‐ vascularization MRI. vascularization vascularization M MRI. RI.

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diagnosis

MRI

MRI MRI ddiagnosis iagnosis

2015 vol 15 no 1

11

Table 6. Histopathological examinations of the bone margin

Bone margins (n)

Healed ulcers

37

Unhealed ulcers

12

Total

49

Histopathological diagnosis Normal Bone marrow edema Bone marrow edema Gangrene

Currently, the appropriate surgical margin for full remission of DFO is not known. In the present study, we examined 49 bone margins by histopathology and demonstrated that when the bone margin was set in the area of bone marrow oedema, the chances of cure were high, and that diligence was essential with cases of severe soft tissue infection or ischemia.

We propose an appropriate surgical strategy based on MRI and histopathology. In neuropathic ulcers (type I and III), the localisation of osteomyelitis is identified by MRI and the surgical margins are determined on the MR images of the bone (in the area of bone marrow oedema), and the range of soft tissue infection. Because no methods are currently available for diagnosing the range of soft tissue infections, it has to be defined, in part, empirically. Type II ulcers, CLI, are of dry gangrene caused by ischemia, and preoperative MRI is not effective for diagnosis, therefore the site of resection has to be determined based on the sufficiency of blood supply after revascularisation. Type IV ulcers, CLI with infection, are the most difficult to treat because of the decision regarding which to carry out first, revascularisation for ischemia or debridement for infection.

Except for cases requiring emergency debridement for infection, we advocate evaluation of osteomyelitis using MRI after revascularisation and setting of the bone margin in the area of bone marrow oedema. Thus, the appropriate surgical margin should be based on not only the range of osteomyelitis, but also on the range of soft tissue infection or the sufficiency of blood supply.

Toes in each type(n) I 0 4 0 0 4

II 2 2 0 8 12

III 2 8 2 0 12

IV 5 14 2 0 21

Total 9 28 4 8 49

Our study has several limitations. First, the definitive diagnosis of DFO requires both histopathological findings and isolation of bacteria from bone samples2. To show the localisation of osteomyelitis, we used histopathological findings in the diagnosis. Second, our bone samples were from toes, metatarsals, and a cuboid bone. Although the forefoot is not the only site of diabetic foot ulcers, it is the most common11. Third, the classification6 chosen for categorizing ulcers is not universal. Our Kobe classification7, a hybrid of the University of Texas11 and the Wagner classification12, have recently been used in Japan. In Asia, type 2 diabetes is becoming epidemic, characterized by rapid rates of increase within a short period, onset at a relatively young age, and a low body mass index13. A distinct discipline of podiatric medicine such as that in United States or Europe is not available in Asia; therefore, the establishment of a classification system that is more relevant to Asian populations is necessary.

In conclusion, although the present study comprised a limited number of patients, we were able to recommend an appropriate surgical margin and strategy based on MRI and histopathology. These continuing studies are therefore aimed at salvaging as much of the diabetic foot as possible.

REFERENCES 1 Lipsky BA. Treating diabetic foot osteomyelitis primarily with surgery or antibiotics: have we answered the question? Diabetes Care 2014;37(3):593-5.

5 Fujii M, Armstrong DG, Terashi H. Efficacy of Magnetic Resonance Imaging in Diagnosing Diabetic Foot Osteomyelitis in the Presence of Ischemia. J Foot Ankle Surg 2013;52: 717-23.

2 Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG et al. Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis 2012:54:e132-73.

6 Terashi H, Kitano I, Tsuji Y. Total management of diabetic foot ulcerations-Kobe classification as a new classification of diabetic foot wounds. Keio J Med 2011;60:17-21.

3 Lipsky BA, Peters EJG, Senneville E, Berendt AR, Embil JM, Lavery LA et al. Expert opinion on the management of infections in the diabetic foot.

Diabetes Metab Res Rev 2012;28(1):163–78.

4 Fujii M, Terashi H, Tahara H. Efficacy of Magnetic Resonance Imaging in Diagnosing Osteomyelitis in Dabetic Foot Ulcers. J Am Podiatr Med Assoc 2014;104(1):24-9.

12

7 Rayman G, Vas PR, Baker N, Taylor CG Jr, Gooday C, Alder AI et al. The Ipswich Touch Test: A simple and novel method to identify inpatients with diabetes at risk of foot ulceration. Diabetes Care 2011;34:1517-8.

8 Morrison WB, Schweitzer ME, Batte WG, Radack DP, Russel KM. Osteomyelitis of the foot: relative importance of primary and secondary MR imaging signs. Radiology 1998;207:625-32.

9 Aragón-Sánchez J. Treatment of diabetic foot osteomyelitis: A surgical critique. Int J Low Extrem Wounds 2010;9:37-59.

10 Ha Van G, Siney H, Danan JP, Sachon C, Grimaldi A. Treatment of osteomyelitis in the diabetic foot.

Contribution of conservative surgery. Diabetes Care 1996;19:1257-60.

11 Armstrong DG, Lavery LA, Harkless LB. Validation of a diabetic wound classification system: the contribution of depth, infection, and ischemia to risk of amputation. Diabetes Care 1998;21:855–9.

12 Wagner FW. The dysvascular foot: a system for diagnosis and treatment. Foot Ankle 1981;2:64–122.

13 Chan JC, Malik V, Jia W, Kadowaki T, Yajnik CS, Yoon KH, Hu FB. Diabetes in Asia: epidemiology, risk factors, and pathophysiology. JAMA 2009;301:2129– 40.

EWMA Journal

2015 vol 15 no 1

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Science, Practice and Education

Ex vivo platelet activation with extended duration pulse electric fields for autologous platelet gel applications

V. Bogdan Neculaes1

A new, potential clinical standard for platelet activation and perspectives for a more widespread adoption and improved wound healing with platelet gels ABSTRACT Background: Abstract: Activated platelet-rich plasma (PRP), also known as “platelet gel,” has emerged in clinical use as the preferred delivery vehicle for physiological combinations of autologous growth factors in wound-healing applications. Although a review of the literature shows encouraging results for wound healing using autologous platelet gels, a more widespread adoption of this approach has been prevented for the following reasons: a) lack of clinical standard for activation, b) challenges with current activation methods, and c) incomplete reporting of PRP preparation, PRP composition, and growth factor levels post activation and how these relate to clinical outcomes. We introduce here a novel instrument-based method for ex vivo platelet activation that eliminates the various challenges posed by the current platelet activator bovine thrombin (high cost, complex workflow, possible side effects) and has the potential for standardisation in clinical practice. We also demonstrate growth factor release using our instrument-based method and evaluate the potency of these growth factor mixes in simple models of angiogenesis and epithelialisation.

Andrew Torres1 Antonio Caiafa1

INTRODUCTION Suboptimal wound healing represents a major threat to public health and an enormous financial burden to the healthcare system1. Tens of millions of patients worldwide present every year with difficult-to-heal wounds. The major causes of these chronic skin ulcers are pressure (decubitus ulcers), venous stasis disease, and diabetes mellitus. It is estimated that 1%–2 % of the population in developed countries will suffer from chronic wounds during their lifetime1. More than 25% of the 29 million individuals with diabetes in the United States will develop a diabetic foot ulcer within their lifetime2 resulting in about 200 amputations daily3, 4.

There is a pressing need to significantly improve outcomes for patients with chronic wounds, with enhanced safety and much lower costs. The use of autologous growth factors derived from platelets has emerged in the last decade as a promising woundhealing approach and has been explored for a variety of clinical applications, including diabetic foot ulcers, dentistry, cardiac surgery, sports medicine, and cosmetic surgery5-8. Upon activation, platelets release multiple growth factors9 with crucial roles in tissue regeneration, angiogenesis, and epithelialisation10, 11.

Activated platelet-rich plasma (PRP), also known as platelet gel, is a delivery vehicle for autologous growth factors involved in the wound-healing cascade. Platelet gel is the only known approach for delivering physiological combinations of growth factors than can act synergistically to repair wounds.

The workflow for the preparation of autologous platelet gel involves several steps: 1) blood draw from the patient; 2) PRP separation from whole blood, typically via centrifugation; 3) PRP activation using calcium chloride and thrombin (typically bovine thrombin), which results in clotting and growth fac-

Christine Morton1

Adriana Larriera1 Steve Klopman1

Ken Conway1

Allen L. Garner2 1 GE

Global Research, Niskayuna, NY, USA, 12309 2 Purdue University, West Lafayette, IN, USA, 47907 Correspondence: neculaes@research.ge. com Conflicts of interest: None

 EWMA Journal

2015 vol 15 no 1

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tor release; and 4) application of platelet gel to the wound site.

Bovine thrombin is the most widely used platelet activator in the clinic. However, bovine thrombin is expensive, needs specific storage conditions and logistics, and may trigger side effects. A previous study states that â&#x20AC;&#x153;30% of the patients exposed to bovine thrombin develop cross-reacting antibodiesâ&#x20AC;?12. Bovine thrombin-associated immune-mediated coagulopathy costs from $16,584 to $163,072 per patient13. Some countries - Europe, Japan etc. - do not allow the use of bovine thrombin in the clinic14. Other types of thrombin (recombinant thrombin, human thrombin from donor plasma) have not overcome the cost and side effect challenges15, and autologous thrombin does not seem to be an effective platelet activator16. Additionally, the use of thrombin for platelet activation has not been standardised in clinical practice. The lack of an activation standard has been one of major challenges for the clinical application of platelet gel.

A promising platelet activation method that offers several advantages over bovine thrombin (cost, ease of use, no known side effects, potential for standardisation) has emerged recently. This method uses electric field pulses for ex vivo platelet activation17,18.

ergonomics needed for in vitro biology and research-level wound-healing studies. The experimental workflow is user-friendly, and instrument packaging and high-voltage safety measures have been considered during the design phase of this platelet-activation platform.

For this study, we used whole blood donated by healthy human donors. PRP was separated from whole blood via centrifugation (see Fig. 2) using an approved clinical centrifuge. The PRP was then placed in a commercially available low-cost electroporation cuvette that was sterile and disposable (see Fig. 3) and exposed to extended-duration electric field pulses. After activation via electrical stimulation, the activated PRP/platelet gel may be used for wound-healing studies or in vitro analysis, as performed here. Although the power electronics topology of the platelet activation instrument will be described elsewhere, it should be mentioned that the instrument design properly addresses the unique requirements posed by the specific electrical properties of PRP (i.e., highly conductive, which is very different from the low-conductivity buffers used by other classes of instruments designed for electroporation). The instrument has electrical safety measures that enable its easy operation by a healthcare professional with minimal training.

2. AN INSTRUMENT-BASED PLATELET ACTIVATION AS A POTENTIAL NEW CLINICAL STANDARD Research in the last few years has generated encouraging results for platelet activation with pulse electric fields (PEF)17-20. Clotting and growth factors are released using nanosecond-duration electric field pulses (typically hundreds of nanoseconds). Although preliminary studies reported lower levels of growth factor release from pooled platelets exposed to nanosecond PEF compared to those exposed to bovine thrombin17, further research from GE Global Research showed growth factor release at the same level or higher than that of bovine thrombin activation18-20. It has been assumed that nanosecond PEF is needed for platelet activation, since these short pulses may produce specific intracellular effects involved in the activation cascade (e.g., release of intracellular calcium)17.

However, pulse duration at the nanosecond level typically requires expensive and at times unreliable power electronics.

We have discovered that electric pulses longer than 1 microsecond can also activate platelets. The power electronics architecture required to generate these extendedduration pulses is simpler, more reliable, and easier to implement in clinical-grade instruments. We have built the first instrument prototype for platelet activation using extended-duration pulses (see Figure 1). This instrument has the compactness, reliability, ease of use, and

3. MATERIALS AND METHODS A. Platelet-rich plasma preparation We handled whole blood and samples derived from whole blood, such as platelet-poor plasma and PRP, using universal precautions. Single units of human whole blood from individual donors were purchased and shipped overnight at room temperature from a commercial vendorb.

All studies used acid citrate dextrose as an anticoagulant.

We report here experimental results using the blood from a single donor.

For a single preparation of PRP, 60 mL of whole blood was drawn from the original unit of blood using the syringe and needle components of the preparation kitc. The whole blood was injected into the separation consumable (Fig. 2) and centrifuged using the clinically approved centrifuged. Complete separation by centrifugation typically takes 15 minutes (see Fig. 2). We then collected PRP, with

16

Figure 1: Instrument prototypea for ex vivo platelet activation with extendedduration pulse electric fields. The cuvette/consumable -shown in Figure 3- with PRP is placed inside the transparent plastic box on top of the instrument (cuvette holder) for electrical stimulation to trigger platelet activation.

EWMA Journalâ&#x20AC;&#x201A;

2015 vol 15 no 1

Science, Practice and Education

a yield of ~10 mL per 60 mL whole blood used. The PRP was maintained at room temperature for all experiments.

The proportion of platelets in the prepared PRP was threefold higher than in the original whole blood sample.

Figure 2: Consumable used for platelet-rich plasma separation from whole blood (picture showing the consumable post centrifugation). Plateletrich plasma will be extracted with a syringe from the compartment on the left, at the interface between the yellow layer consisting of plateletpoor plasma and the red layer consisting of red blood cells (i.e., buffy coat).

B. Platelet activation 1) Reagents All biochemical reagents were prepared and stored on ice on the day of experiment. A stock solution of bovine thrombine was prepared in saline solution (0.9% NaCl) at a concentration of 10 U/μL to allow for 1:10 (vol/ vol) standard dilution in all experiments. Final concentration after addition to PRP was 1 U/μL. A stock solution of CaCl2f was prepared at 1 M concentration to allow for 1:100 (vol/vol) standard dilution in all experiments. The final concentration after addition to PRP was 10 mM CaCl2.

2) Thrombin-mediated activation of platelet-rich plasma Bovine thrombin (100 U/μL) was added to 0.5 mL PRP with 5 μL PRPCaCl2 (1 M) in 1.5-mL sterile tubesg, diluted 1:100 (final concentration 1U/μL), and then incubated at room temperature. Tubes were then centrifuged at 10,000 rpm for 10 minutes. The resulting supernatant was pipetted from the tube and either used immediately or stored at or below -200C. 3) Pulse electric field-mediated activation of plateletrich plasma For each experiment, 5 μL CaCl2 (1 M) was added to 0.5 mL freshly prepared PRP in a 2-mm cuvetteh (see Figure 3). The sample was subsequently exposed to one electric pulse of extended duration, transferred to a 1.5mL sterile tubei, and incubated at room temperature for approximately 15 minutes. The samples were then centrifuged at 10,000 rpm for 10 minutes. The supernatant was pipetted from the tube immediately after the pulse and either used immediately or stored at or below -200C. C. Growth factor measurements We measured the release of platelet-derived growth factor-AA (PDGF-AA), epidermal growth factor (EGF), and vascular endothelial growth factor (VEGF) using the folEWMA Journal

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Figure 3: A 0.5-mL cuvette used to couple electric fields to plateletrich plasma for activation.

lowing three commercial kits: Human/Mouse PDGF-AA Immunoassayj, Human EGF Immunoassayk, and Human VEGF Immunoassayl. The measurement of PDGF-AA and EGF required supernatant dilutions of 1:10 and 1:20, respectively; for VEGF, no dilution was required. We followed the manufacturer’s protocol for each assay without deviation.

D. Cell proliferation assays MCF-10A cellsm were maintained in media supplemented with 10% foetal bovine serumn. These cells are a non-tumourigenic epithelial line that should respond to growth factors. Human dermal fibroblasts (HDF) and human dermal microvascular cells (HDMVECs)o were each maintained in MCDB-131 mediump supplemented with foetal bovine serum and a culture mediumq. The HDFs model epithelialisation, with increased growth of these cells indicating wound healing. The HDMVECs model vascularisation, with increased growth of these cells indicating the formation of new blood vessels, also important to wound healing.

Cells were seeded at a density of 200,000 cells/cm2 and incubated for 24 hours. The cells were then washed twice with a balanced salt solutionr, and the medium was replaced with serum-free medium and incubated for 24 hours. Supernatant from PRP was diluted to 10% vol/vol with serum-free medium and added to the serum-starved cells (total volume 100 µl), which were then incubated 24 hours. This dilution was determined experimentally with a dose-response characterisation study. ATP was measured as a function of cell proliferation using a luminescence ATP a. GE Global Research b. Bioreclamation, Westbury, NY, USA c. SmartPReP2 APC+ PRP, Harvest Technologies, Lakewood, CO, USA d. Harvest Technologies e. Catalog #91-010, BioPharm Laboratories, Bluffdale, UT, USA f. Sigma Aldrich, St. Louis, MO, USA g. Eppendorf, Thermo Fisher, Hamburg, DE h. Molecular BioProducts, catalog #21-237-2 i. Eppendorf j. Catalog # DAA00B, R&D Systems, Minneapolis, MN, USA k. Catalog #DEG00, SEG00, PDEG00,

R&D Systems l. Catalog # DVE00, R&D Systems m. American Type Culture Collection, Manassas, VA, USA n. McCoy’s, Invitrogen, Grand Island, NY, USA o. VEC Technologies, Rensselaer, NY, USA p. Life Technologies, Grand Island, NY, USA q. EndoGro, VEC Technologies r. Hanks Balanced Salt Solution (HBSS), Invitrogen s. ATPlite 1step Single Addition Luminescence ATP Detection Assay, Perkin Elmer, Waltham, MA, USA

17



! !! !!

detection assay systems according to the manufacturerâ&#x20AC;&#x2122;s recommendations. The experimental conditions used for all cell types were serum starvation, addition of unactivated PRP, addition of bovine thrombin-activated PRP, and addition of PEF-activated PRP. Serum-starved cells were given no additional growth factors; this is considered a basal level of growth. All other conditions were compared to serum starvation as the baseline.

activated PRP supernatant compared to serum-starved cells (baseline control). Using HDMVECs (Fig. 5c) as a surrogate for angiogenesis and HDFs (Fig. 5b) as a surrogate for epithelialisation, our results show that PEF creates a platelet gel with significant effects on epithelialisation and angiogenesis. It is interesting that trends in Figures 5a (MCF10A non-tumourigenic epithelial cell line) and Figure 5b (HDFs) appear similar, which are satisfying results since both of these cell lines are related to epithelialisation.

4. EXPERIMENTAL RESULTS This section presents data on growth factor release from clinical-grade human PRP and cell proliferation to demonstrate the potency of growth factors released upon activation by extended-duration PEF. Figure 4 shows growth factor release results for unactivated PRP, bovine thrombin-activated PRP, and PRP activated by PEF for three growth factors: PDGF-AA, VEGF, and EGF. Compared with bovine thrombin activation, PEF activation triggered similar PDGF-AA release, higher VEGF release, and much higher EGF release.

Figure 5 illustrates the effects of growth factors released via bovine thrombin and PEF activation on cell proliferation. These experimental plots show cell proliferation after 24-hour stimulation with unactivated PRP supernatant, bovine thrombin-activated PRP supernatant, and PEF-

5. DISCUSSION AND NEXT STEPS Our paper introduces the concept of ex vivo platelet activation via extended duration PEF and presents the first instrument prototype designed and validated experimentally for growth factor release from human PRP exposed to electrical stimulation. Our experimental results confirm ! ! the growth factor release obtained recently with nano! !

18 second PEF , showing that electric stimulation releases growth factors at the same level or higher than that produced by bovine thrombin. Cell proliferation assays were used as surrogate measures for wound healing. These assays demonstrate the potency of growth factors released by electrical stimulation of PRP with the instrument shown in Figure 1. Recent in vivo experiments showed improved wound healing with activated PRP via nanosecond PEF compared to PRP activated by bovine thrombin21, the

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Figure 4: Growth factor release with unactivated platelet-rich plasma (PRP NA, negative control), bovine thrombinactivated PRP (BT, positive control), and extended-duration pulse electric field (PEF)-activated PRP. Each bar represents the mean of three measurements and the error bars represent the +/- of standard deviation.

Figure 5: Cell proliferation after adding unactivated platelet-rich plasma (PRP NA), or growth factors released via bovine thrombin (BT) or extended-duration pulse electric fields (PEF). The negative control consisted of serum-starved cells. All other conditions were compared to serumstarved as the baseline.

Each bar represents the mean of three measurements and the error bars represent the +/of standard deviation.

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18

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EWMA Journalâ&#x20AC;&#x201A;

2015 vol 15 no 1

Science, Practice and Education

platelet activator generally used in the clinic today. Additional encouraging findings also suggest that the PRP activated by nanosecond PEF exhibits other improvements over bovine thrombin activation (e.g., higher endogenous antioxidant levels, reduced formation of reactive oxygen species and matrix metalloproteinase-2), hinting towards improved healing outcomes compared to today’s platelet gels21. Since a recent study suggests that intracellular effects may be possible not only with ultra-short, nanosecond PEF but also via pulses of extended duration (>1 microsecond)22, one may expect similar beneficial effects with extended-duration PEF activated PRP (e.g., improved healing, higher antioxidant levels, reduced reactive oxygen species). In addition, the use of extended-duration PEF makes possible a low-cost and reliable instrument for clinical use. More details about the instrument platform design will be presented elsewhere, but in terms of cost per activation, the consumable used in this study (Figure 3) is about 20 times less expensive than bovine thrombin 23. This instrument-based method for PRP activation via electrical stimulation could soon become a standard in clinical workflows, since its activation performance is consistent, does not depend on the operator skill, is easy to implement and control, and the activated PRP does not appear to produce side effects.

Future work should focus on further exploring woundhealing benefits of platelet gels activated by extended-duration PEF in in pre-clinical and clinical applications. There may be additional considerations for wound sizes that can

be addressed with autologous platelet gels when designing these studies. One recent publication describes diabetic wounds with an area of 185 cm2 treated with autologous platelet gel24; another recent work stated that about 45–50 mL whole blood would be needed to generate enough platelet gel to treat a 100 cm2 wound25. It is possible to obtain 130–150 mL whole blood from a patient in a single doctor visit to enable the treatment of a ~ 300 cm2 wound.

Nevertheless, trade-offs in terms of maximum wound size for a patient would need to be made in the clinic.

The new technique of activating PRP at a push of a button, in less than a second, may open the door to improved healing outcomes for patients worldwide suffering from chronic wounds. Recent trends point towards the use of platelet gels not only as a replacement for, but also in addition to more traditional wound-healing approaches (e.g., negative pressure therapy26). Thus, improvements in wound healing may be enabled by the instrument-based platelet activation method introduced here.

ACKNOWLEDGEMENTS The authors would like to thank John Burczak (GE Global Research) for supporting this research, and James Rothman (Yale University), Alan Michelson (Harvard Medical School and Center for Platelet Research Studies at Boston Children’s Hospital) and Andrew Frelinger (Harvard Medical School and Center for Platelet Research Studies at Boston Children’s Hospital) for valuable suggestions in this project.

REFERENCES: 1. Sen CK, Gordillo GM, Sashwati R, Kirsner R, Lambert L, Hunt TK, Gottrup F, Gurtner GC, Longaker MT. Human Skin Wounds: A Major and Snowballing Threat to Public Health and the Economy. Wound Repair Regen 2009;17(6):763–71 2. Diabetes Latest. Centers for Disease Control and Prevention 2015. http://www.cdc.gov/features/ diabetesfactsheet/ [Accessed 27.03.15] 3. Dougherty EJ. An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers. Adv Skin Wound Care 2008;21(12):568-75 4. Statistics About Diabetes. American Diabetes Association 2014. http://www.diabetes.org/diabetesbasics/statistics/ [Accessed 27.03.15] 5. Mazzucco L, Medici M, Serra M, Panizza R, Rivara G, Orecchia S et al. The use of autologous platelet gel to treat difficult-to-heal wounds: a pilot study. Transfusion 2004;44(7):1013-8 6. KM Lacci, A Dardik. Platelet-rich plasma: Support for its use in wound healing. Yale J Biol Med 2010;83:19.

7. Driver VR, Hanft J, Fylling CP, Beriou JM et al. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage 2006;52(6):68-70, 72, 74 passim.

8. Tate KS, Crane DM. Platelet rich plasma grafts in musculoskeletal medicine. J Prolotherapy 2010;2(2):371-6.

9. Frechette JP, Martineau I, Gagnon G. Platelet-rich plasmas : growth factor content and roles in wound healing. J Dent Res 2005;84(5):434-9.

10. Singer AJ, Clark RAF. Cutaneous wound healing. N Engl J Med 1999;341(10):738-46.

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11. Kiritsy CP, Lynch SE. Role of Growth Factors in Cutaneous Wound Healing: A Review. Crit Rev Oral Biol Med 1993;4(5):729-60.

12. Diesen DL, Lawson JH. Bovine thrombin: history, use, and risk in the surgical patient. Vascular 2008;6 (Suppl 1):29-36.

13. W Alexander. Meeting highlights of the 30th American College of Clinical Pharmacy annual meeting. Pharmacy & Therapeutics 2009;34(12):68890.

14. ThermoGenesis Autologous Thrombin Processing Device (TPD) Receives CE Mark to Allow Sales in Europe. PR Newswire 2015. http://www.prnewswire. com/news-releases/thermogenesis-autologousthrombin-processing-device-tpd-receives-ce-mark-toallow-sales-in-europe-54525062.html [Accessed 27.03.15] 15. DJ Cada, T Levien, DE Baker. Thrombin, Topical (Recombinant). Hosp Pharm 2008;43(7):577–85.

16. Textor JA, Tablin F. Activation of equine platelet-rich plasma: comparison of methods and characterization of equine autologous thrombin. Vet Surg 2012;41(7):784-94 17. Zhang J, Blackmore PF, Hargrave BY, Xiao S, Beebe SJ, Schoenbach KH. Nanosecond pulse electric field (nanopulse): A novel non-ligand agonist for platelet activation. Arch Biochem Biohpys 2008;471:240-8.

18. Torres AS, Caiafa A, Garner A, Klopman S, LaPlante N, Morton C, Conway K, Michelson AD, Frelinger AL, Neculaes VB. Platelet activation using electric pulse stimulation: growth factor profile and clinical implications. J Trauma Acute Care Surg 2014;77(3 suppl 2):94-100 19. Neculaes VB, Torres A, Caiafa A, Klopman S. Ex-vivo platelet activation using electrical stimulation for autologous platelet gel wound healing applications.

Presentation at the 24th Conference of the European

Wound Management Association, Madrid, Spain, May 2014.

20. LaPlante N, Neculaes VB. DB Lee, SA Torres , Conway K, Klopman S, Caiafa A. Ex-vivo Platelet Activation using Electric Pulse Stimulation. In Proceedings of the 6th International Conference on Biomedical Electronics and Devices (BIODEVICES 2013), Barcelona, February 11-14, 2013, Spain, pages 202-8.

21. Hargrave BY. Autologous Platelet Rich Plasma (Platelet Gel): An Appropriate Intervention for Salvaging Cardiac Myocytes under Oxidative Stress after Myocardial Infarction. Anat Physiol 2014;4:134 22. Weaver JC, Smith KC, Esser AT, Son RS, Gowrishankar TR. A brief overview of electroporation pulse strength–duration space: A region where additional intracellular effects are expected. Bioelectrochemistry 2017;87:236-43.

23. Cheng CM, Meyer-Massetti C, Kayser SR.A review of three stand-alone topical thrombins for surgical hemostasis. Clin Ther 2009;31(1):32-41 24. Tzeng YS, Deng SC, Wang CH, Tsai JC, Chen TM, Burnouf T. Treatment of Nonhealing Diabetic Lower Extremity Ulcers with Skin Graft and Autologous Platelet Gel: A Case Series. Biomed Res Int 2013.

DOI: 10.1155/2013/837620 25. Obolenskiy VN, Ermolova DA, Laberko LA, Semenova TV. Efficacy of platelet-rich plasma for the treatment of chronic wounds. EWMA J 2014;14(1):37-41 26. Bello AMJ, Fernandez VM, Garcia FY, Oubina BR, Anton FV, Perez AM et al. Complicated surgical wound management with negative pressure therapy and autologous platelet-rich plasma. Presentation at the 24th Conference of the European Wound Management Association, 14-16 May 2014, Madrid, Spain

19

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Science, Practice and Education

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at a free paper session (Free paper session: Pressure Ulcers) at the EWMA - GNEAUPP 2014, Madrid

Pressure ulcer reduction: The role of unregistered healthcare support workers in validation and prevention

BACKGROUND Pressure ulcer (PU) incidence is a key quality indicator of both patient safety and care quality, and has a variety of uses, including benchmarking, organisational comparison, measurement improvements, and commissioning.

Aim To evaluate the impact of a specialist Health Care Assistant (HCA) in Tissue Viability (TV) for PU surveillance and prevention within an acute hospital setting.

Methods A comparison of an 18-month pre-change incidence audit with PU incidence monitored monthly for 3 years.

Results The total number of category 2-4 PUs acquired in the hospital totalled 228 in the 2009/2010 reporting period (April to March). Validation was not achieved in a significant proportion of cases prior to the service evaluation. Due to changing service needs during the first 2 years, the accuracy of category 1 PU data was inconsistent. By the 2013/2014 reporting period (April to March), the total number of category 2-4 PUs totalled 71, representing a 69% reduction.

Conclusions The TVHCA is able to respond quickly to reports of new PUs at early stages of development. The provision of primary validation ensures accurate data monitoring and allows for early specialist advice and guidance for PU prevention.

INTRODUCTION The incidence and prevalence of pressure ulcers (PUs) has been highlighted in the UK as a key indicator of both patient safety and care quality1. Organisations have undertaken the challenge of commissioners and the general public to demonstrate improvements in patient safety through data reporting.

The safety thermometer is a point prevalence audit that is undertaken monthly in every National Health Service (NHS) organisation in England. This audit was introduced in 2012, and over 700 organisations were using it routinely by 20132. Among other measures of patient safety, PU prevalence is noted and reported externally. The Tissue Viability Society3 produced a consensus statement that raised concerns about the use of prevalence as a measure of an individual organisation’s performance. Although prevalence identifies the total number of PUs present in the population, incidence measures new occurrences within the context of the setting4. An individual organisation can be held accountable only for incidence levels, as they often have little or no control over the delivery of services within another organisation. Although incidence may be a more robust measure of performance and progress for a distinct organisation, it is not without its challenges. Ensuring that good inter-rater reliability, prompt reporting of accurate data, and the provision of meaningful statistical analysis is achieved can all prove to be problematic in a large organisation.

In 2010, the Royal Devon and Exeter NHS Foundation Trust realised the importance of the accurate collection of data on which to base its analysis of patient safety. Outcomes such as falls have incidence levels that are easy to calculate, as there is little debate about whether a fall is a fall. However, PUs can be much more difficult for general nursing staff to accurately record and report. This fact is illustrated by healthy debate amongst specialists about systems of categorisation and where a particular lesion might fall in that system5. This system does not even account for

Michael B. Ellis BNurs(Hons) RN

Juliet Price BSc(Hons) RN Department of Tissue Viability Royal Devon and Exeter NHS Foundation Trust Barrack Road Exeter Devon EX2 5DW UK Correspondence: michael.ellis2@nhs.net Conflicts of Interest: None

 EWMA Journal

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21

the debate about whether a lesion is indeed a result of pressure or some other aetiology. The literature suggests that training can improve the agreement between nurses about the grade of the lesion. One particular study, which used photographs to assess agreement between nurses, demonstrated that reasonable levels of inter-rater reliability could be achieved; however, the authors noted that differentiation could be more difficult in real practice6.

Although incidence monitoring had been undertaken using a central electronic system for 3 years prior to this evaluation, the accuracy of the data was questionable due to problems with inter-rater reliability. It was determined that the input of tissue viability (TV) specialists would be required to obtain an accurate picture of PU incidence.

Due to pressure from rising costs, the recruitment of additional Registered Nurses (RNs) was infeasible, and so a project was conceived to establish a Tissue Viability Health Care Assistant (TVHCA) post. This post would focus purely on PU validation and the provision of protocolbased advice to clinical staff to promote the delivery of effective PU prevention.

METHODS A retrospective audit of recorded pressure damage, including data about EPUAP and NPUAP (2009) category, the site of the damage, whether the damage was sustained in hospital or prior to admission, and the hospital ward where the damage was first noted, was undertaken from May 2009 until October 2010. A prospective audit of the same data was collected for a 3-year period from the start of this service evaluation. Data for a further 7 month period was also available after the defined end-point of the project at the time of submitting this article and was not included in the study.

The TVHCA recruited to the post was an experienced HCA with experience in general nursing care on acute inpatient wards. As part of the training process, the TVHCA was required to undertake PU classification training, including the use of an electronic learning programme (PUCLAS) and PU risk assessment training. In addition to theoretical learning, two weeks of supervised practice was conducted to ensure consistent validation. Routine monitoring of a random sample of 5 patients was undertaken on a weekly basis as a quality assurance measure, and all category 2, 3, or 4 PUs were independently validated by a TV Clinical Nurse Specialist (CNS).

Using a ward-based electronic reporting system (White board), all pressure damage or suspected pressure damage was recorded when noted by ward nursing staff. The damage was graded by ward staff according to the EPUAP and NPUAP classification system7. The ward staff also noted whether the patient developed the pressure damage during this hospital episode or if it was present upon admission 22

to the facility (i.e., developed at home, a care home, or another facility).

On a daily basis (weekdays only), the TVHCA would run a report and obtain records of all damage recorded for the previous 72 hours (to account for weekends and bank holidays). Every patient with hospital-acquired pressure damage graded as a category 2 or above would then be reviewed by the TVHCA. The category of damage was validated and early interventions were implemented with protocol-based advice. There were no pre-defined quantitative measures by which to judge success beyond a pragmatic view of incidence reduction for category 2-4 hospital-acquired PUs with a progressive downward trajectory across the 3-year period. Data are presented in a descriptive way to show the incidence figures.

Due to the success of the service evaluation during the study period, additional funding was made available to extend this programme to include all hospital-acquired pressure damage and all community-acquired pressure damage.

RESULTS The PUs are reported by the month of the patientâ&#x20AC;&#x2122;s discharge rather than the month in which the PUs were validated, which is a pragmatic choice that was made to fit with the reporting requirements of the service commissioners. The monthly external report displays the data for all the PU categories. At the start of the project period, category 1 PUs were validated by the TVHCA but as reporting improved and the number of pressure ulcer requiring validation increased, it was not possible to continue validating category 1 PUs. Both hospital-acquired category 1 PUs and all community-acquired PUs were not validated between October 2012 and April 2013 when a second TVHCA was recruited. Graph 1 displays data that relate to hospital-acquired category 1-4 PU data. Graph 2 displays only category 2-4 PU data, the measure by which the project success was evaluated.

Prior to the service evaluation, the retrospective audit revealed a category 1-4 PU incidence rate of 2.77 per 1000 bed days and a category 2-4 PU incidence rate of 0.81 per 1000 bed days. The total incidence rate per 1000 bed days for the whole service evaluation period was 1.91 for category 1-4 and 0.53 for category 2-4 PUs. In the period following the completion of the service evaluation, this rate has continued to fall to an incidence rate per 1000 bed days of 0.70 and 0.23, respectively.

DISCUSSION The downward trajectory of hospital-acquired PU in all categories is in part attributed to a better understanding of the data. Using the HCAs to validate the PU category and the origin of the PU has proven to be an effective way to EWMA Journalâ&#x20AC;&#x201A;

2015 vol 15 no 1

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Category 1-4 per 1000 Bed Days 4.50

4.00

Preliminary Audit

Number of Pressure Ulcers per 1000 Bed Days

3.50

3-Year Project Period 3.00

Validation of category 1 PU restarted

Validation of category 1 PU stopped

2.50

2.00

PostProject Audit

1.50

1.00

0.50

0.00

Month

Graph1: Category 1-4 incidence reduction data.

Category 2-4 per 1000 Bed Days 2.50

Number of Pressure Ulcers per 1000 Bed Days

2.00

Preliminary audit

1.50

1.00

3-Year Project Period Postproject audit

0.50

0.00

Month

Graph 2: Category 2-4 incidence reduction data.

gather this data in a consistent and reliable way. However, there are some limitations to the data presented.

The data gathered is not able to differentiate between the number of PUs initially reported and the number validated. However, there exists evidence that good validation positively affects the number of PUs reported externally.

The project’s success in more accurately determining EWMA Journal

2015 vol 15 no 1

pressure damage in the hospital demonstrates a need to more accurately understand the impact that communityacquired pressure damage has on incidence figures. The increase in workload and the number of patient visits generated by validating all categories of pressure damage regardless of its origin led to the pragmatic decision to stop the validation of category 1 damage by the HCA in 23



Graph 3: Point prevalence audit data.

August 2012. A 25% increase in the number of category 1 PU was recorded in the following year’s data. Although these PUs were validated by ward matrons, the quality and reliability of the validation is questionable. Anecdotally, the TVHCA noted that patients were receiving either too much or too little intervention based on inaccurate assessments of the aetiology and severity of PUs. The reallocation of workload, additional funding, and an adjustment in work practices allowed the team to expand. In July 2013, an additional 0.5 whole-time equivalent TVHCA was employed to further extend the validation and advice service. In the following 12 months, the incidence of category 1 PUs fell by almost 50%. Although this is not direct proof that validation and advice is responsible for this decrease, and other factors may have played a significant role, it is difficult to believe that validation and advice does not contribute significantly.

The reduction of incidences reported correlates with a reduction in total prevalence reported (Graph 3). The prevalence data is gathered from the safety thermometer and although the data is more stable as would be expected from prevalence figures compared to the national data suggesting prevalence of between 4.4% and 4.7% in 201320148 There is a natural link due to incidence validation, but because the TVHCA also validates all communityacquired pressure damage noted within the acute hospital, many of these incidences are removed from the reported data. This has been reported as being due primarily to incorrect aetiology. Because of payments linked to incidence reduction targets9, there is a temptation to attribute PUs to another healthcare provider. This would keep the prevalence figures high but reduce our own incidence figures. The validation undertaken by the TVHCA has been shown to be a robust mechanism for monitoring both sets of data and ensuring agreement.

24

Although data validation is a key component of this role, the front-line clinical advice regarding risk and riskprevention strategies has allowed the TV service to be more visible and more responsive. The ward staff now have greater access to advice and support from someone who can be physically available rather than available by phone only. There is no data to distinguish the impact that this availability has had. Anecdotally, it has been reported by ward-based staff that the visibility of the TVHCA has had a significant impact. The awareness of PUs has been raised and support to provide appropriate intervention has been optimised.

In the first 12 months of the evaluation between November 2010 and October 2011, there were 368 category 1, 130 category 2, 57 category 3, and 3 category 4 PUs. In the final 12 months of the evaluation between November 2012 and October 2013, there were 359 category 1, 59 category 2, 18 category 3, and 0 category 4 PUs, which represents a reduction of 9 category 1, 71 category 2, 39 category 3, and 3 category 4 PUs. Based on estimates of the average cost for the treatment of PUs in the UK10, the organisation has shown comparative savings for the health economy from year 1 to year 3 of the service evaluation of £10,926 in category 1, £372,211 in category 2, £162,738 in category 3, and £42,324 in category 4 PUs. This represents a total of £588,199 per year assuming that approximately the same number of PUs would have developed each year without this programme and that the average costs of healing are representative of the local population healing rates. The average cost of a band 3 nurse (TVHCA) was calculated at £17,794. When compared with the potential economic advantages of this role and the apparent cost savings generated by reduced incidence, it is difficult to argue against the benefit of a TVHCA. As a result, other specialist areas of practice, such as diabetes,

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have devised similar roles to aid with the monitoring of care and delivery of protocol-based advice to ward staff.

CONCLUSION The accurate measurement of incidence allows for a more robust report of the safety of care delivered within an organisation. This service evaluation has been responsive to changing needs within the organisation about the validation of pressure damage and, as such, has evolved. During periods of change, the role of the TVHCA has continued to develop, and the extent to which their input is necessary has become apparent. Using an unregistered member of the healthcare team allows for a cost-effective way of providing protocol-based advice and guidance to frontline clinical staff, and has improved both the validity and reliability of data collection. Although the reduction in incidence cannot and should not be wholly attributed to the input of the TVHCA, this reduction demonstrates the important role that accurate data can play in assessing service improvements in an open and honest way.

Implications for clinical practice: n Healthcare organisations can improve the reliability of pres sure ulcer validation data to enable more accurate reporting

of this quality indicator with targeted investment. n Patient outcomes can be improved by providing a higher

level of clinical support and early intervention. n Front-line clinical staff who observe improvements in safety

outcomes for patients may have improved levels of morale

and work in a more proactive way as a team. n Healthcare organisations may be able to make significant

cost savings or attract bonuses by demonstrating improve ment in incidence levels.

Further research: n A qualitative study to explore the reported impact of the

TVHCA would be useful in understanding the way that this

role is able to support practice in comparison to specialist nurses. n A retrospective audit of the difference between recorded

pressure ulcers prior to validation and subsequently validat ed pressure damage may help in understanding the educa tional needs of front-line nursing staff.

REFERENCES 1. Department of Health. The NHS outcomes framework 2012/13. London: Department of Health; 2011

5. White R, Clark M, Newton H. Is pressure ulcer classification working for clinicians? Wounds UK 2012;8(4):12-4.

2. Power M, Fogarty M, Madsen J, Fenton K, Stewart K, Brotherton A, Cheema K. Harrison A, Provost L. Learning from the design and development of the NHS Safety Thermometer. Int J Quality Health Care 2014:26(3):287-97.

6. Beeckman D, Schoonhoven L, Fletcher J, Furtado K, Heyman H, Paquay L, et al. Pressure ulcers and incontinence-associated dermatitis: effectiveness of the Pressure Ulcer Classification education tool on classification by nurses. Qual Saf Health Care 2010;19(5):e3.

3. Dealey C, Chambers T, Beldon P, Benbow M, Fletcher J, Fumarola S, et al. Achieving consensus in pressure ulcer reporting. J Tissue Viability 2012;21(3):72-83.

4. Shields L, Twycross A. The difference between incidence and prevalence. Paediatric Nursing 2003;15(7):50.

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7. European Pressure Ulcer Advisory Panel and National Pressure Ulcer Advisory Panel. Treatment of pressure ulcers: Quick Reference Guide. Washington DC: National Pressure Ulcer Advisory Pane; 2009.

8. Clinical Audit Support Unit. NHS Safety Thermometer: Patient Harms and Harm Free Care, England, November 2013 - November 2014, official statistics.

London: Health and Social Care Information Centre 2014.

9. NHS Institute for Innovation and Improvement.

Commissioning for Quality and Innovation (CQUIN) payment framework. In: CQUIN Framework. 2013: http://www.institute.nhs.uk/commissioning/pct_portal/ cquin.html [Accessed 1 May 2014].

10. Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care 2012;21(6):261-6.

25

E-Learning

about Pressure Ulcers and Incontinence - Associated Dermatitis (IAD)

What is new?

• Four modules: • Introduction to pressure ulcers • Introduction to Incontinence- Associated Dermatitis (IAD) • Pressure ulcer classification • Differentiation between pressure ulcers and IAD • Assessment modules and certificate • Separate assessment module including cases and photographs • Simpler navigation and content separation

EPUAP members have free access to PUCLAS3!

More information available at www.epuap.org and www.PuClas3.UGent.be

Science, Practice and Education

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to EWMA Journal, based on a presentation given at a free paper session (Free paper session: Quality of life) at the EWMA - GNEAUPP 2014, Madrid

Measuring change in limb volume to evaluate lymphoedema treatment outcome

ABSTRACT The accurate, non-invasive measurement of limb volume in patients with lymphoedema is important in the clinical and research setting.

Aim This paper provides an overview of the practical approaches to assessing limb volume and calculating changes in limb volume after treatments in patients with unilateral lymphoedema.

Methods Techniques for assessing limb volume are described, and a case study example is presented. A compression bandaging system comprised of a foam roll and cohesive, inelastic bandages was applied to 9 patients with unilateral lymphoedema on 6 occasions over a 12-day treatment period. Two parameters for measuring the changes in limb volume after the course of treatment were used to evaluate treatment outcomes. n Parameter 1: percentage change in excess limb volume over time. n Parameter 2: percentage change in absolute limb volume over time.

Results In 9 patients, the mean percentage change in excess limb volume at Day 12 was 35%, and the mean percentage change in absolute limb volume was 8%.

Conclusions The two parameters for calculating changes in limb volume are not interchangeable. Parameter 1 is only suitable for patients with unilateral lymphoedema, but provides the information on the reduction of lymphoedema (excess) volume. Parameter 2 can be used for patients with bilateral lymphoedema, where no comparator or unaffected limb is available. Both parameters should be reported in research, and both limbs should be measured, if possible. However, Parameter 2 should be used with caution, as the percentage change is based on the whole limb volume, rather than the more accurate excess limb volume as a measure of lymphoedema.

INTRODUCTION A key characteristic of lymphoedema is increased limb volume. The accurate, non-invasive measurement of limb volume is essential in the clinical and research setting. The change in limb volume is an important treatment outcome in determining the effect of decongestive treatments, such as compression bandaging. This manuscript provides an overview of the practical approaches for assessing limb volume and describes two parameters for calculating the changes in limb volume over time. Nine patients with unilateral lymphoedema participated in an audit of a lymphoedema bandaging system comprised of a foam roll and cohesive inelastic bandages (Fig. 1). This bandaging system was applied on 6 occasions over a 12-day treatment period.

WHY MEASURE LIMB VOLUME? Measuring limb volume can be a useful tool in establishing the extent and stage of lymphoedema and identifying the treatment outcomes1,2. In patients with unilateral lymphoedema, the difference between the affected and unaffected limb volume is expressed as the excess limb volume, which is often reported as a percentage of the volume of the unaffected limb (Table 1). A grading system for unilateral lymphoedema based on the excess limb volume has been established2:

Anne F. Williams PhD, MSc, RN, DN, Dip Nurse Ed Lecturer in Nursing Queen Margaret University Edinburgh EH21 6UU Scotland

Justine Whitaker MSc, RN Director and Lymphoedema Nurse Consultant, Northern Lymphology Ltd, Senior Lecturer, University of Central Lancashire, UK

Correspondence: anne@esklymphology. co.uk Financial support was provided from Activa Healthcare for the bandaging audit and the original presentation at EWMA 2014. This manuscript is based on the original presentation.

n

<20% = mild lymphoedema n 20–40% = moderate lymphoedema n >40% = severe lymphoedema In patients with bilateral lymphoedema, monitoring the volume of each limb can provide information on the treatment and self-management outcomes over time, thus enabling both patients and practitioners to recognise any change in individual limb size. However, as there is no unaf

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27

Figure 1: Application of the bandaging system, which was comprised of the spiral application of a foam roll* and the figure-of-eight application of the cohesive, inelastic bandages**

* Rosidal Soft, Lohmann & Rauscher, Rengsdorf, Germany ** Actico, Activa Healthcare, Staffordshire, United Kingdom

fected control limb, the actual (excess) volume of lymphoedema cannot be accurately established in someone with bilateral swelling. Similarly, no fully validated and reliable method exists for establishing the lymphoedema volume in patients with swelling in the head, neck, genitalia, and trunk2.

TECHNIQUES FOR MEASURING LIMB VOLUME Various techniques for measuring limb volume have been reported in the literature. n Tape measure n Water displacement n Perometer TAPE MEASURE This is the most practical and portable technique in the therapeutic setting. Most commonly, the limb is marked and measured at 4-cm intervals1. Circumferential measurements are recorded (Table 1), and measurements can be compared over time for each point, thereby 28

Table 1: Recording circumferential measurements in Patient A (a woman with lower limb lymphoedema). The cylinder equation is used.

Before treatment After treatment Right limb Left limb Right limb Left limb affected unaffected (cm) affected (cm) unaffected (cm) (cm) DISTAL 21.7 29.0 21.4 25.5 24.0 33.1 23.6 28.5 28.4 38.7 28.1 32.6 33.4 42.2 33.3 38.6 35.9 43.6 35.5 37.5 36.0 44.0 35.8 40.0 35.2 43.1 35.0 39.5 34.0 40.3 33.7 37.6 34.3 41.0 34.0 38.4 Distal limb volume0 2,904 4,524 2,856 3,651 (ml)0 Excess volume (ml)0 1,620 795 % excess0 56% 28% PROXIMAL 38.5 44.0 38.8 41.5 41.2 46.3 41.5 44.1 44.0 49.8 43.2 45.5 48.0 52.0 48.0 47.0 51.9 51.9 51.5 51.6 53.0 57.0 53.2 56.6 55.5 57.9 56.5 57.7 57.5 59.8 57.9 60.2 Proximal limb0 6,145 7,045 6,182 6,609 volume (ml)0 Excess volume (ml)0 899 427 % excess0 15% 7% Total limb volume0 (ml)0 Excess volume (ml)0 % excess0

9,050

11,569

9,038

10,260

2,519 28%

-

1,222 14%

-

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Table 2: Two equations for calculating limb volume Volume of a cylinder: the limb is viewed as a series of cylinder-shaped segments.

Volume of each segment = C²/π C is the circumference at the midpoint of a segment with a length of 4 cm. Therefore, the starting point for the first measurement is 2 cm above the wrist or ankle.

Total limb volume is determined by the sum of the segment volumes.

Volume of a truncated cone: the limb is viewed as a series of truncated cone or frustrum-shaped segments.

Volume of each segment = L/12π (C1² + C1 C2 + C2²) C1 and C2 are the circumferences at either end of a segment length (L). The starting point for the measurement is at the wrist or ankle, which represents the first point of the distal truncated cone.

Total limb volume is determined by the sum of the segment volumes.

Table 3: Limb volume calculations before treatment in Patient A Total limb volume The calculation of total limb volume (ml): Right leg: 9,050 Left leg: 11,569 Excess limb volume comparing affected and unaffected limbs The difference between the limb volume of the affected and unaffected limbs in a patient with unilateral lymphoedema (ml): 11,569 – 9,050 = 2,519 Percentage difference in excess volume The excess limb volume is expressed as a percentage of the unaffected limb volume. This 3 indicates how much larger the affected limb is compared to the unaffected limb.

2,519 x 100 = 28% 9,050 Volume of different segments of the limb The limb is divided into the distal and proximal segments, and the total volume, excess volume, and percentage excess volume are reported for each segment. This is particularly useful if the swelling is not evenly distributed (for example, below the knee only).

Distal segment volumes (ml)

Proximal segment volumes (ml)

Affected distal segment: 4,524 Unaffected distal segment: 2,904 Excess volume of distal segment: 1,620 % excess volume of distal segment: 1,620 x 100 = 56% 2,904

Affected proximal segment: 7,045 Unaffected proximal segment: 6,145 Excess volume of proximal segment: 899 % excess volume of proximal segment: 899 x 100 = 15% 6,145

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giving precise information on the distribution of swelling and changes in limb circumference. Any change in limb circumference may indicate an increased or reduced fluid volume. These changes may also be influenced by the alterations in muscle mass, fat tissue, and tissue fibrosis. As such, an unaffected limb should always be measured as the control, as symmetrical change can be expected in response to factors, including exercise and weight loss.

Circumferential measurements can be entered into computer software programmes or pre-programmed calculators to calculate limb volume and, in unilateral swelling, excess limb volume. Most commonly, two formulae are used to calculate the volume (Table 2), although the limb is rarely shaped like a true cylinder or truncated cone (frustrum). The calculation of the limb volume, excess volume, and percentage excess volume can be established for the whole limb, distal segments, and proximal segments, thus providing specific information on the distribution of oedema within the limb (Table 1). In the example shown in Table 1, the excess volumes before treatment at the distal and proximal sections of the limbs are very different (56% and 15%, respectively).

This indicates an uneven distribution of swelling, which is not evident in the whole limb volume excess figure of 28%.

When the measurement method is precise and standardised, evidence indicates that circumferential methods are valid and reliable3,4,5 (Table 4). The actual limb volume achieved will depend on the size and shape of each limb segment and the method of calculation6-8. The formulae (cylinder or truncated 29



Table 4: Tips for achieving accuracy using the tape measure method • Consistent limb position • Consistent tape type, width, and tension: some practitioners use a pre-tensioned tape to standardise • Accurate and consistent marking of the starting and subsequent measurement points throughout the limb: for example, marking the starting point as a consistent distance from the base of the nail bed of the middle finger • Standardisation of the measurement as below and above the marked point • Consistent number of measurement points used • Measurements by the same operator at the same time each day

Table 5: Using two outcome parameters to calculate changes in limb volume after treatment in Patient A Parameter 1: Parameter 2 Pre-treatment excess volume: 2,519 ml Pre-treatment absolute volume of the affected leg: 11,569 ml Post treatment excess volume: 1,222 ml Post-treatment absolute volume of the Change in excess volume: affected leg: 10,260 ml 2,519 – 1,222 = 1,297 ml % change in excess volume: 1,297 x 100 = 52% 2,519

Change in absolute volume of the affected leg: 11,596 – 10,260 = 1,336 ml % change in absolute volume: 1,336 x 100 = 15.5% 11,596

cone) must be used consistently and are not interchangeable5,7. The hand or foot is not included in the calculation of limb volume, although approaches to measuring the hand have been explored9.

WATER DISPLACEMENT METHOD This method is often viewed as the gold standard2 and is mainly used in research. It relies on measuring the amount of water that is displaced from a container when the limb or part of the limb is submerged. This provides information on the volume of the whole limb, including the hand or foot, and can be used to accurately measure the hand or foot alone7. The total volume of each limb can be used to calculate the excess and percentage excess volume of the whole limb, hand, or foot. This is generally not practical for clinical use.

Circumferential measurements have been shown to correlate well with water displacement3,5,10,11, although the reported volumes from water displacement are often slightly lower than those from the circumferential measurements4. Therefore, the methods are not interchangeable.

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PEROMETER METHOD (OPTOELECTRONIC PLETHYSMOGRAPHY) This device uses infra-red sensors to measure the limb7, 12. The limb is placed within a frame that does not touch the limb but is moved along the length of the limb. The method has some disadvantages, as it is expensive, is only suitable for the clinical setting, and relies on the patient being able to hold the limb steady in a specific position: for example, the arm is generally abducted. The machine provides various readings, including limb volume, and 5 produces a visual representation of the limb, which may be particularly useful for patient education.

Tan et al.13 examined the agreement between a vertically orientated perometer and the tape measure method in volunteer legs. He concluded that the methods were reliable but not interchangeable, as the tape measure overestimated the limb volume in comparison to the Perometer.

CALCULATIONS OF LIMB VOLUME Details of limb volume, excess limb volume, and percentage excess volume of the limb, as well as sections of the EWMA Journal

6 2015 vol 15 no 1

Science, Practice and Education

Table 6: Use of Parameter 2 to calculate the percentage change in absolute limb volume Example 1: Example 2: Limb volume before treatment: 10,000 ml

Limb volume before treatment: 16,000 ml

Limb volume after treatment: 8,000 ml

Limb volume after treatment: 14,000 ml

Reduction in limb volume: 2,000 ml

Reduction in limb volume: 2,000 ml

Expressed as a percentage of the starting Expressed as a percentage of the starting treatment volume: treatment volume: 2,000 x 100 = 20% 2,000 x 100 = 12.5% 10,000 16,000

Table 7: Measuring limb volume change in nine patients with unilateral lymphoedema during a 12-day course of lymphoedema bandaging Parameter 1: Change in excess limb volume

ID1 ID2 ID3 ID4 ID5 ID6 ID7 ID8 ID9 Mean

Excess volume (ml) at Day 1 (pretreatment)

Excess volume (ml) at Day 12 (posttreatment)

Change in excess volume (ml)

% change in excess volume

1,788 1,789 3,501 1,446 1,708 3,485 4,182 4,760 5,650 3,145

1,045 968 2,581 1,107 471 2,536 3,736 2,295 4,944 2,187

-743 -821 -920 -339 -1,237 -949 -446 -2,465 -706 -958

-42 -46 -26 -23 -72 -27 -11 -52 -12 -35

Parameter 2: Change in absolute volume of the affected limb Before After Change % treatments: treatments in limb change affected : affected volume in limb limb volume limb (ml) volume (ml) volume (ml)

8,709 11,995 11,021 10,396 8,631 9,135 13,376 13,399 17,039 11,522

7,966 11,174 10,101 10,057 7,394 8,483 12,966 10,931 16,222 10,588

limb such as the distal and proximal segments, can be calculated (Tables 1 and 3). Practitioners must understand the implications of any data which are obtained through software packages or calculators. This ensures that (1) circumferential measurements are taken at the correct intervals with a precise starting point, (2) data are correctly entered, and (3) any feedback that is given to patients or recorded for the clinic or research purposes is accurate.

The formula for a cylinder requires the first circumferential measurement to be taken at 2 cm above the wrists or ankle (midpoint of the cylinder). The frustrum formula requires measurements at the end of each segment, so the first circumference is taken directly at the wrist or ankle.

ESTABLISHING THE CHANGE IN LIMB VOLUME AFTER TREATMENT In a patient with unilateral lymphoedema, reporting excess volumes before and after treatments also enables a calculation of absolute and percentage change in excess limb volume in relation to the pre-treatment excess volume (Table 5). This is the most accurate representation EWMA Journalâ&#x20AC;&#x201A;

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-743 -821 -920 -339 -1,237 -652 -410 -2,468 -817 -934

-9 -7 -8 -3 -14 -7 -3 -18 -5 -8

of the actual change in the amount of lymphoedema in the affected limb and is particularly useful for research and audit purposes.

When a patient has bilateral lymphoedema, the excess volume cannot be calculated. Instead, the reduction in absolute limb volume may be expressed as a percentage of the pre-treatment 7 total limb volume in each affected limb. However, this does not provide precise details of the lymphoedema volume or change in the lymphoedematous component of the limb. As shown in Table 5, two outcome parameters were used to calculate the changes in the affected limb of a patient with unilateral lymphoedema. The two methods produced very different results. Although Parameter 1 relied on the unaffected leg as a control, the result from Parameter8 2 was influenced by the initial volume of the limb.This is further illustrated in the examples given in Table 6 where two limbs have each reduced by 2000mls, although the calculation of percentage change, based on the initial limb volumes of 10,000mls and 16,000mls, are very different. Importantly, it is impossible to know how much of an initial limb volume is due to lymphoedema in a patient with bilateral swelling. î&#x201A;Š 31

APPLICATION IN AN AUDIT Nine patients with unilateral lower limb lymphoedema participated in an audit of a bandaging system incorporating the spiral application of a foam roll and the figureof-eight application of cohesive, short-stretch bandages14.

The patients were bandaged over 12 days with a total of 6 applications of the bandaging system (Fig. 1). The limb volume was calculated using the formula for a cylinder before and after the 12-day treatment course. Circumferential measurements were taken at 4-cm intervals along the affected and unaffected limb, starting 2 cm above the ankle. These data were entered into a spreadsheet to calculate the limb volume, excess volume, and % excess volume.

The changes in limb volume in the 9 patients (Table 7) were expressed using two parameters. n

Parameter 1: percentage change in excess limb volume over time. n Parameter 2: percentage change in absolute limb volume over time.

RESULTS The results from the 9 patients with unilateral lymphoedema show a mean reduction in the excess limb volume of 35% (range 11–72%) when Parameter 1 was used (Table 7). This was similar to the mean reduction of excess volume of 33.5%, which was reported by Badger et al.15 in a study of 31 patients after 18 days of bandaging. Using Parameter 2, the mean reduction in the absolute limb volume in the 9 patients who took part in the audit was 8% (Table 7).

CONCLUSIONS The two parameters for calculating the change in limb volume yielded different results and were not interchangeable. Our results suggest that Parameter 1 is only suitable for patients with unilateral lymphoedema, but provides information on the reduction in lymphoedema volume.

Parameter 2 may be used for patients with bilateral lymphoedema, where no comparator (unaffected) limb is available.

Both parameters should be reported in research, and both limbs should be measured. However, Parameter 2 should be used with caution, as the percentage reduction is based on the whole limb volume. The accurate representation of limb volume reduction cannot be achieved using Parameter 2, where the extent of lymphoedema is unknown, as a comparison with the unaffected limb is not possible. However, both parameters are useful in the clinical setting to monitor changes in the limb volume over time.

To ensure accuracy, practitioners should use standardised, valid, and reliable approaches when assessing limb volume change. Limb volume measurements should be used in conjunction with other quality of life measures and patient-reported outcomes to provide a more holistic perspective on progress and change. Future work could involve the use of a larger dataset to examine the correlations between different approaches to quantifying limb volume reduction.

REFERENCES

1. Lymphoedema Framework. Best Practice for the Management of Lymphoedema, International consensus. London: MEP Ltd.; 2006. Available at: http://ewma.org/fileadmin/user_upload/EWMA/ Wound_Guidelines/Lymphoedema_Framework_Best_ Practice_for_the_Management_of_Lymphoedema.pdf [Accessed 03.11.14].

Bilateral and Unilateral Limb Edema. Phys Ther 2007;87(10):1362-8.

measurements for lymphoedema: implications for the SNAC trial. ANZ J Surg 2008;78(10):889-93.

6. Sitzia J. Volume measurement in lymphoedema treatment: examination of formulae. Eur J Cancer Care (Engl) 1995;4:11–6.

12. Adriaenssens N, Buyl R, Lievens P, Fontaine C, Lamote J. Comparative study between mobile infrared optoelectronic volumetry with a Perometer and two commonly used methods for the evaluation of arm volume in patients with breast cancer related lymphedema of the arm. Lymphology 2013;46(3):132-43.

2. International Society of Lymphology (ISL). The diagnosis and treatment of peripheral lymphoedema.

Consensus document of the International Society of Lymphology. Lymphology 2013;42:1-11.

3. Sander AP, Hajer NM, Hemenway K, Miller AC. Upper-extremity volume measurements in women with lymphedema: a comparison of measurements obtained via water displacement with geometrically determined volume. Phys Ther 2002;82:1201-12.

4. Taylor R, Jayasinghe UW, Koelmeyer L, et al.

Reliability and validity of arm volume measurements for assessment of lymphedema. Phys Ther 2006;86:205–14.

5. Mayrovitz HN, Macdonald J, Davey S, Olson K. & Washington E. Measurement Decisions for Clinical Assessment of Limb Volume Changes in Patients With

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7. Stanton AWB, Badger C, Sitzia J. Non-invasive assessment of the lymphedematous limb. Lymphology 2000;33:122-35.

8. Katz-Leurer M, Bracha J. Test-retest reliability of arm volume measurement in women with breast cancer-related lymphoedema. J Lymphoedema 2012;7(2):8-13.

9. Borthwick Y, Paul L, Sneddon M, McAlpine L, Miller C. Reliability and validity of the figure-of-eight method of measuring hand size in patients with breast cancer-related lymphoedema. Eur J Cancer Care 2013;22:196-201.

10. Karges JR, Mark BE, Stikeleather SJ, Worrell,TW. Concurrent validity of upper extremity volume estimates: comparison of calculated volume derived from girth measurements and water displacement volume. Phys Ther 2003;83:134–14.

11. Tewari N, Gill PG, Bochner MA, Kollias J. Comparison of volume displacement versus circumferential arm

13. Tan C-W, Coutts F, Bulley C. Measurement of lower limb volume: Agreement between the vertically orientated perometer and a tape measure method.

Physiotherapy 2013;99(3): 247-51.

14. Whitaker J, Williams A, Pope D, Charles H, Muldoon J. Sub-bandages pressures and comfort in a lymphoedema bandaging system with a foam layer and cohesive short stretch bandages. Poster at Harrogate Wound Care Conference, 2013.

15. Badger C, Peacock J, Mortimer P. A randomisedcontrolled parallel-group clinical trial comparing multi-layer bandaging followed by hosiery versus hosiery alone in the treatment of patients with lymphedema of the limb. Cancer 2000;7:2832-38.

EWMA Journal

2015 vol 15 no 1

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Scientific Communication

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at Plenary Session: Innovation, Know-How, and Technology at the EWMA - GNEAUPP 2014, Madrid

Emerging targeted technology to address unmet clinical needs - Implementing a development and adoption strategy

When faced with a new or challenging clinical situation, healthcare professionals often, of necessity, innovate by adapting or inventing new care strategies. Despite having a clear drive to innovate and create new medical devices and systems of care, healthcare professionals have frequently not been in the forefront of product development. As a result, healthcare systems have received products and services that were “pushed” to them by industry. These products may not be aligned with the development strategy of healthcare organisations.

Moreover, they may not address perceived or actual patient needs. As such, they are not “owned” by clinicians or end users.

Changes that are more radical or disruptive have a greater likelihood of eliciting resistance to implementation. There will always be early adopters.

However, products or system changes are unlikely to be widely disseminated if (1) the “technology” fails to deliver or (2) there are inflated expectations.

WHAT IS INNOVATION? Innovation is the successful implementation of new ideas and is divided into three stages:

The CEO of the National Health Technology Adoption Centre, Sally Chisholm, stated: “The need for the rapid, widespread, and systematic adoption of innovation within the NHS has never been more acute.” The same clearly applies to all healthcare systems. If this is the case, then why are innovations not rapidly adopted and universally applied? Currently, the Innovation/Adoption/Diffusion cycle for new medical devices is too long, and it takes an estimated average of 17 years for only 14% of new scientific discoveries to enter dayto-day clinical practice1. This introduces barriers to full adoption and is often controlled by regulatory requirements, reimbursement, and healthcare provider acceptance. If the process is too slow, newer technology becomes available. Innovation is then discouraged, as manufacturers are unable to recoup development costs before the next wave of products launches. The Dutch Royal Academy of Science has recently produced a report2 entitled “Evaluation of New Technology in Healthcare,” in which they offer guidance on the evaluation, use, and regulation of medical devices. The report

n

Invention or identification – finding new or improved ways of doing things through new devices, therapies, or systems n Adoption – testing new or improved ways of doing things and putting them into practice n Diffusion – replicating new or improved devices, therapies, or processes across the system Although innovation is linked to a process of improvement, it is frequently seen as part of the change process. Innovation may be:

n

Incremental - building on and improving existing practices n Radical – solving existing problems using a completely new approach n Disruptive - creating an entirely new and unexpected therapy, market, or mode of working

WHAT IS INNOVATION WITHIN HEALTH CARE? “An idea, service, or product that is either new to a healthcare system or applied in a way that is new to that system and significantly improves the quality of health and care wherever it is applied”.

Professor Peter Vowden Consultant Vascular Surgeon and Visiting Professor of Wound Healing Research, Bradford, UK Clinical Director of the NIHR Healthcare Technology Co-operative for Wound Prevention and Treatment in Bradford, UK. Correspondence: peter.vowden@bthft.nhs.uk Conflicts of interest: None

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The eight National Institute for Health Research (NIHR) Healthcare Technology Co-­‐operatives (HTCs)

NHS Organisation Barts Health NHS Trust Cambridge University Hospitals NHS Foundation Trust Guy’s and St Thomas’ NHS Foundation Trust Sheffield Teaching hospitals NHS Foundation Trust Bradford Teaching Hospitals NHS Foundation Trust

Clinical Area or Theme Chronic gastrointestinal disease Brain injury Cardiovascular disease Devices for Dignity Wound prevention and treatment (WoundTec HTC) Leeds Teaching Hospitals NHS Trust Colorectal therapies Nottinghamshire Healthcare NHS Trust, Institute of Mental health and neurodevelopmental Mental Health disorders University Hospitals of Birmingham NHS Foundation Trust Trauma management

Table 1 The eight National Institute for Health Research (NIHR) Healthcare Technology Co-operatives (HTCs)

covers a number of issues that are relevant to all healthcare systems, irrespective of the country or area in which they provide services. However, the pressure to rapidly deliver and adopt innovation must not be at the expense of patient safety. Good evidence demonstrating clinical and cost effectiveness must be derived from well-constructed clinical trials. Follow-up post-marketing surveillance data play a vital role in ensuring that data derived from randomised studies are repeated in real-world situations3. A criticism that is frequently raised in medical device-related clinical trials, particularly in the field of wound care products, is a lack of consistency and comparability between studies.

This issue is frequently highlighted in systematic reviews4, and the need to work in accordance with the CONSORT statement is further emphasised5. To overcome this, a common platform for evaluation that is similar to the suggested platform for telemedicine (MAST)6 should be introduced.

This framework would require both a generic “wound care”-related core and a disease-specific focus that deals with the characteristics of individual wound types, such as diabetic foot ulceration, venous leg ulcers, malignant wounds, or acute traumatic wounds.

“Innovation is an ongoing cycle ……. one without a beginning or an end, where one idea always leads to the next.”

Diffusion occurs for a number of reasons; (1) Bottom-up pressure from patients, public demand, and individual choice; (2) horizontal pressure from peers, outcome reporting, collaboration, competition, and marketing; (3) top-down pressure from central requirements, regulations, incentives, and guidance.

Diffusion is also dependent on the cost-effectiveness model that supports the launch of the initial product, as derived from the original clinical trials, which are replicated for general use. This model can be challenged by the 36

slow uptake of educational support within the healthcare system, changes within the system itself, and the skill of the general healthcare professional when compared to that of an experienced research team. The Whole System Demonstrator trial7 of telemedicine has highlighted the need for careful economic and clinical evaluations of new devices and systems of care in the management of chronic disease8.

Technology acceptance can be related to two key functions: the perceived usefulness of the innovation and perceived ease of use. When considering, developing, or introducing innovation, address the following questions: n

Is the new behaviour/system/device genuinely useful?

How will the “learner” know if it is useful? n Is the new behaviour/system/device easy to use? n If it is not easy to use, can anything be done to improve it? n

HEALTHCARE TECHNOLOGY CO-OPERATIVES (HTCS) In an attempt to address areas of unmet clinical need in the NHS, the National Institute for Health Research (NIHR) has established eight HTCs (Table 1), which have been established to: n

Act as a catalyst for the NHS “pull” for the develop ment of new medical devices, healthcare technologies, and technology-dependent interventions. n Focus on clinical areas and/or themes of high morbid ity, which have high potentials for improving the qual ity of life for NHS patients and improving the effective ness of healthcare services that support them. n Work collaboratively with patients, patient groups, charities, industry, and academics.

The NIHR WoundTec HTC specifically addresses innovation that is related to unmet needs in wound prevention and treatment9. This HTC has specific aims: EWMA Journal

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Scientific Communication

n

Act as a platform for innovation To carry out these aims, the NIHR WoundTec HTC is Identify and develop promising concepts for medical working through a formal collaboration between strate devices gic partners and a network of key stakeholders (patients, n Provide theoretical, methodological, and design patient groups, charities, academics, and industry). The expertise and a clinical base to develop these concepts HTC has taken on a leadership role in identifying unmet into testable interventions and devices needs and developing and translating integrated clinical n Test the feasibility, effectiveness, cost effectiveness, and and research knowledge to patient care, thereby improv acceptability of proposed innovations in NHS settings ing the life of patients, enhancing standards of wound and various care pathways and promote the spread of management, and promoting wealth creation. î&#x201A;Š Figure 1 best practice Identifying areas of need: Patient and Public Involvement n

Figure 1 Identifying areas of need: Figure 2 Patient and Public Involvement

Potential for increased features to impact production schedule, product cost, profit, complexity, and adoption

Figure 2 Potential for increased features to impact production schedule, product cost, profit, complexity, and adoption.

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“How do you make innovation possible? With a need that launches an idea.”

One of the core strategies in this process is Patient Led Innovation (PLI), which involves: n

Transforming patient-identified needs into innovative medical devices and/or services. n Innovating existing products and services to meet the needs of patients and carers. n Speeding up the development process. n Providing patient feedback and regular interactions with designers, engineers, industry healthcare profes sionals, and researchers.

This is achieved by engaging with patients throughout an innovation-led design process (Fig. 1). However, several challenges remain. A proper way to engage with patients to identify need must be implemented. Furthermore, the conversion from product “push” to need-initiated “pull” needs to be developed. End-user feedback during the design phase has the potential to improve effectiveness but

may also impact product cost and cost effectiveness when additional features and functionality are introduced (Fig. 2).

When looking at innovation in wound care products, Moues et al.10 asked if we, the healthcare professionals, are one of the barriers to innovation. They commented that although a greater understanding of wound biology and technological advances have led to numerous improvements in wound care in the last two decades, the choice of therapy still largely depends on high-quality marketing, expert opinion, and intuition, rather than scientific evidence. They state that many healthcare professionals continue to treat and dress wounds according to age-old practices, despite the fact that new research shows that this may not be the best treatment modality for the patient.

In the UK Chief Executive’s report by Sir David Nicholson for the NHS in England, Sir David Nicholson recognised, in his forward to Innovation Health and Wealth (2011), the need for innovation. Paraphrasing some of his comments:

“Our ambition must be for an NHS defined by its commitment to innovation, demonstrated both in its support for research and its success in the rapid adoption and diffusion of the best, transformative, most innovative ideas, products, services, and clinical practice.”

“Now and for the foreseeable future, we must meet health demands from within our current real terms funding while at the same time improving quality ……. This means that simply doing more of what we have always done is no longer an option. We need to do things differently.

We need to radically transform the way we deliver services ……..

Innovation is the way – the only way – we can meet these challenges.

Innovation must become core business for us all.”

References 1. Westfall JM, Mold J, Fagnan L. Practice-based research-”Blue Highways” on the NIH roadmap.

JAMA 2007;297(4):403-6.

2. KNAW Evaluation of new technology in health care.

In need of guidance for relevant evidence. 2014, Amsterdam, KNAW. 3. Yera-Alos IB, Alonso-Carbonell L, Valenzuela-Silva CM, Tuero-Iglesias AD, Moreira-Martinez M, Marrero-Rodriguez I, et al. Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers. BMC Pharmacol Toxicol 2013;14:44.

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4. Clark M, Black J, Alves P, Brindle C, Call E, Dealey C, et al. Systematic review of the use of prophylactic dressings in the prevention of pressure ulcers. Int Wound J 2014;11(5):460-71.

5. Weller C, McNeil J. CONSORT 2010 statement: updated guidelines can improve wound care. J Wound Care 2010;19(8):347-53.

6. Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, et al. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care 2012;28(1):44-51.

7. Greenhalgh T. Whole System Demonstrator trial: policy, politics, and publication ethics. BMJ 2012;345:e5280; author reply e305.

8. Henderson C, Knapp M, Fernandez JL, Beecham J, Hirani SP, Cartwright M, et al. Cost effectiveness of telehealth for patients with long term conditions (Whole Systems Demonstrator telehealth questionnaire study): nested economic evaluation in a pragmatic, cluster randomised controlled trial. BMJ 2013;346:f1035.

9. Vowden P. New wound care HTC launches. J Tissue Viability 2013;22(1):19-20.

10. Moues CM, Heule F, Legerstee R, Hovius SE. Five millennia of wound care products--what is new? A literature review. Ostomy Wound Manag 2009;55(3):16-22.

EWMA Journal

2015 vol 15 no 1

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Juan Reig Medical Doctor, Specialist in General Surgery, Former President of the EUROREC Institute, Osuna Health Area, Andalucia, Spain.

Jose A. Valverde Medical Doctor, Specialist in Emergency Medicine, Empresa Pública de Emergencias Sanitarias (EPES 061), Sevilla, Andalucia, Spain.

Monica Reig Medical Doctor, Specialist in General and Digestive Surgery, Surgery Department, San Juan de Dios Hospital, Bormujos (Sevilla), Andalucia, Spain.

Keywords: health technology, innovation, ICT, early adopter, technological trends, transformational technologies Correspondence: jreigr@gmail.com Reprints: jose.valverde.albacete@ gmail.com Conflicts of interest: None

42

Great opportunities ahead!

Don’t miss the boat!

Where tech meets health care…

ABSTRACT Technology is transforming almost everything in our daily lives, and there are few spaces or sectors not affected by this unavoidable change. However, sometimes our pace of coping with change is not always as good as it should be. In this article, we review recent technological breakthroughs and discuss ways by which they can improve the work of healthcare professionals and allow us to deliver better care to our patients. Which technologies will have the greatest impact on wound management and the closely related field of chronic care? We suggest that big data, 3D printing, communication and collaborative technologies, and innovative devices can lead to higher quality and more efficient care.

Not only new technologies, but also new professional roles, societal challenges, and the sense of personal empowerment are deeply changing the way we deliver care. These factors in combination with advancements in medicine, genetics, neuroscience, new materials, nanosensors, increased consciousness about environment and energy as well as the influence of other non-medical disciplines opens the way for progress in the healthcare arena. Such advancements are closely tied to ethical, privacy, and security concerns that should be thoroughly considered.

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at Plenary Session: Innovation, Know-How, and Technology at the EWMA - GNEAUPP 2014, Madrid

INTRODUCTION “Prediction is very difficult, especially about the future,” said Niels Bohr, winner of the Nobel Prize in Physics. However, it is also true that we must take risks. In our work and daily lives, we cannot rely on making mistakes as a way of learning and avoid guessing what may happen in the future. Based on the evidence we have today, we use this article to imagine how tomorrow will look. Contrary to many opinions, we are convinced that the best is yet to come.

That is, advances in medicine, neuroscience, genetics, information and communications technology (ICT), and technology in general; new roles for individuals and society; and increasing concern for our environment together set a foundation for progress in the health sector, which appears full of opportunities.

These future developments will occur in a synergistic manner. Isolated advances are not only difficult but are often doomed to failure. The future is relentless. We cannot hide and believe that we are not going to be affected.

As individuals in a changing social environment we want to play a leading role in the healthcare ecosystem and have key decision power over ourselves and other public and private actors, whether organisations, providers, payers, or insurers.

Determinants of progress in the health sector include mobility; breaking the physical links to fixed areas, organisations, or traditional processes; vanishing distance and barriers; democratisation of technology access; emergence of new professional roles; generation of large amounts of information from heterogeneous and accessible sources; and growing interest in the environment and the proper use of energy resources1.

Today’s technology enables us to more easily manage the healthcare policies we design and to implement our vision. It is no longer merely a tool for EWMA Journal

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executing an idea; rather, it has intrinsic value and acts as a catalyst or enabler of strategy. As decision makers, we cannot wait until a technology is mature or else we will lose competitive advantage. Instead, we must become “early adopters” if we want to differentiate ourselves, and we must actively use and benefit from technology in our daily lives, because its potential to improve quality of life for the patients or support the role of health professionals has never been more obvious.

TECHNOLOGICAL INNOVATIONS In this current global economic crisis, the healthcare system is highly valued by its users, who not only apply constant and incremental pressure to gain access to the last technological innovations but who also benefit from affordability of common technologies. At the same time, healthcare professionals do not perceive ICT as important to their work.

There is a rationale for this changing environment.

As a driving force common to all industries and not just the health sector, technology is now an integral part of everyday life. Technology has become invisible and is incorporated as a natural part of life, not just for younger generations considered “digital natives” but also for society as a whole.

The intensity of innovation and the incorporation of new technologies unprecedented, and the resulting changes increasingly affect us individually and collectively.

Moreover, the growth of computer networks, their increasing accessibility, and the rise of content sharing in the cloud leads to a distribution of information across devices and systems without barriers. Because the content of the information is the same, only slight variations in sizes and formats need to be considered when presenting the information.

Another driver of change is that solutions from other sectors are now permeating the health sector. We cannot continue saying that healthcare is different and that strategies from other sectors do not work or do not apply to our environment.

The concept of health itself is constantly evolving, not only in relation to the paradigm shift from cure to prevention, but also in terms of including broader concepts such as welfare or “wellness”, as well as integrating traditional remedies and other unconventional therapies. For example, a currently available app for weight control not only includes tools for measuring calorie intake, keeping track of exercise, and monitoring metabolism, but also incorporates information on personal mood, shared goals among social networking groups, and personalised virtual “coaching” messages.

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conditions or their experiences in healthcare systems reflects a different reality of today’s society. We care more and more about opinions, suggestions, tips, and ideas from our neighbours in social networks, and this virtual meeting space will be increasingly present as an everyday part of the healthcare process, building the concept of “conversation”. 1 !

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Figure 1. Word cloud of terms used in this report (www.worldle.net).

Aspects of the health system such as the experience of patients—a concept that exceeds the classical term “satisfaction”—and good communication can influence the quality of care and improve health outcomes. Such aspects are eventually recognised either because they improve treatment adherence, for example, or because they generate confidence and positively impact the course of a disease or condition2. The incorporation of technology into our daily lives can greatly improve patient experiences, allowing personalised communication and increasing a sense of belonging in and closeness to the healthcare system.

In summary, we believe that technological and societal innovations are directly influencing the challenges that face our healthcare system at patient, professional, and organisational levels.

IDENTIFYING TRENDS The concept of “transformational technology” relates to how some technological elements have the ability to induce deeper disruptive changes than the functions for which the technology was originally designed3,4. It is opposed to adaptive technology or transition technologies considered as simple evolutions or improvements on performance. Classic examples are the World Wide Web, Internet search engines, and the mobile phone.

Experts consider six groups of technologies with the potential to transform the healthcare sector5,6: big data, connectivity (including interoperability), improvements in computer manufacturing (e.g., micro and nanotechnology, graphene), 3D printers, cloud computing, and the Internet of Things. These are not considered isolated elements but rather different pieces of a jigsaw puzzle. For example, 43

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common healthcare technologies within the Internet of Things, improved positioning systems, and miniaturisation can offer opportunities to reduce risks of medical or diagnostic errors and enable less invasive treatments.

Let’s review the possible contributions of each of these six technologies.

The amount of data produced is estimated to grow by 60% annually. When we talk about big data7, we are referring to the 2.5 quintillion (2.5 × 1018) bytes of data generated daily8. Big data is characterised by the “4 V’s”: volume, referring to the continued increase in the amount of data produced; velocity, referring to the speed at which data is generated and used; variety, referring to the heterogeneous nature of data obtained from multiple sources; and veracity, referring to uncertainty in the value of data and its contribution to decision making.

Connectivity is necessary to ensure that our technological world works smoothly. It is the “sine qua non” for data exchange between devices or intercommunication between machines. Connectivity must occur at high speed and capacity, without barriers, to allow data to easily flow in an unobstructed manner and to be filed automatically but with some degree of control. Connectivity is one of the biggest challenges of the near future due to the exponential increase in the number of connected devices and terminals, the volume of data exchanged, the need for connections to be permanently available and safe, the numerous mechanisms and means of connections, and the need for a single device to simultaneously connect to different nodes of the network and in different ways. The healthcare environment will become a hyper-connected space where interoperability plays an unquestionable role.

Although computing power in the past has traditionally been linked to computers, today computer power is present in most different devices in our everyday lives.

Improvement in the manufacture of computing elements is another element of the technological transformation of our health system. Nanotechnology and the miniaturisation of components, the integration of graphene circuits and plates, and the embedding of computing modules in almost any element of the healthcare environment will profoundly change our near-future reality. As an example, chip-based systems for examination, diagnosis, and treatment can be capable of transmitting data and images.

3D printers can also play a role in solving health problems. For instance, a recent New England Journal of Medicine paper describes the creation of an implant using a 3D printer and biomaterials to treat a child with tracheobronchomalacia9. The possibilities of producing prostheses or tissue on demand, adapted to the particular anatomy of each patient, are tremendous. In the future, we will refer to “cell cartridges” and “organ printers”!

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Remote storage or cloud computing is another great revolution in today’s industries, including healthcare. Although a secure cloud is possibly the greatest demand of the health sector, in general, this technology can greatly contribute to the advancement of ICT and be widely implemented in healthcare. Hybrid public/private clouds that are immediately available whenever and wherever needed, regardless of where the data are stored, can be powerful tools for professional work. The paradigm shift from ownership of resources to availability of services (e.g., Software as a Service) radically changes the approach to business in the health sector, helping to implement concepts such as availability of relevant clinical information at the point of care or effectively build unique electronic health records10.

One key issue, however, is the necessary synchronisation of information across all devices, systems, and media.

The Internet of Things11 refers to the 6,000 million artefacts potentially connected to the Internet by 2015, many of which are related to health and wellness. In conjunction with other technologies, the potential savings from the use of remote monitoring and control systems for the treatment of chronic diseases could reach 20%.

Moreover, their potential for application in other aspects of care management, especially those related to quality, safety, or productivity, is considerable. However, there is the risk that devices in patients’ homes or personal networks can be hacked or malfunction, which warrants the need to consider security and ethics. The Internet of Things enables concepts such as ambient intelligence, which will have much influence on the health environment. The combination of this technology with connectivity and miniaturisation of sensors will expand its use exponentially in the coming years. Like connectivity, Interoperability is necessary to allow the predicted massive deployment of technology.

A concept that reflects both technological and sociological trends is “Bring Your Own Device” (BYOD)12. In the health sector, this has obvious implications for security and privacy, but it is spreading, aided by two factors: 1) the near-universal availability of tablets, smartphones, or similar devices and 2) the economic crisis, which minimises investments.

WHERE TO EXPECT NEW DEVELOPMENTS Advances in the consolidation, analysis, and interpretation of big data will provide objective evidence that can aid clinical diagnosis and treatment, care planning, and, more importantly, produce a radical change allowing anticipation to the health evolution. This information will be more valuable if it can be used to anticipate the occurrence of health events, either through the simple analysis of large datasets, the use of algorithms, or the use of artificial intelligence tools.

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In contrast to today’s sporadic measurement of vital signs, the immediate future leads us to continuous nonintrusive monitoring and control of physiological activities, even in healthy individuals, in any place and under any condition. Such monitoring can be performed through embedded technologies that form an integral part of health spaces or that even exist in our clothing, and such monitoring will in most part be transparent to the end user.

Another element of great importance for improving the efficiency of the health system as a whole has to do with finding and using information. There will be a breakthrough in the emergence of intelligent and focused search engines that will be able to continuously provide personalised information to patients based on their specific conditions. Such information can be provided in a way that encourages motivation, commitment, and adherence to treatments and activities for self-management and selfcare, thus significantly increasing the ability of people to make decisions in a more informed manner. Also, on the service provider side, knowledge-based decision support systems for qualified professionals will spread improving availability of updated clinical evidence and resources when needed.

People in the health system will not only participate as individuals but also as members of a community.

We are transitioning from a system focused and composed of individual health professionals to one composed of health care teams coordinated by a personal health counsellor, who is not necessarily a medical professional. Understanding that patients are the centre of the health system serves to drive this paradigm shift.

What to expect in wound care? Let’s expect technology that will support more effective and secure care based on anticipation and prevention rather than just cure, technologies that speed up healing through printed 3D skin patches, better information systems for follow-up and maintenance, and new collaborative tools that improve communication and coordination among members of the care team. An example of such an advance is smart surgical sutures that are sensitive to temperature or infections and are capable of sending information about wound status from their micro-sensors, thus enabling a fast and efficient response13.

Obviously, these advances will be distributed asymmetrically across our health system. As a result, the coexistence of different levels of development and different stages of implementation will undoubtedly lead to practical difficulties in day-to-day performance.

CONCLUSIONS The aim of this short article was to convey the wide range of opportunities and upcoming technological trends in healthcare settings over the next few years. Healthcare professionals will enjoy greater patient participation and coresponsibility, technologies that are more helpful and easy to use, more accurate and less invasive diagnostic tests, and more personalised treatments. Above all, however, they will have enhanced ability to anticipate, prevent, and perform.

In terms of sociological trends, we make note of empowerment, co-creation, sharing, online reputation, community, collective or mass intelligence, and the concept of conversation.

Progress driven by technological and sociological trends should flourish in sustainable health systems characterised by high social support, efficiency, and the ability to adapt to new circumstances, in which technology is no longer just a tool but an indissoluble part of their development.

Will we be able to re-imagine (almost) everything? It will be the only way to achieve a healthier future.

REFERENCES 1 Reig J. El Reto de la eficiencia en el sistema sanitario.

Las ideas de los expertos. Club GerTech, 2013. http:// www.clubgertech.com/wp-content/ uploads/2013/03/12636-El-reto-de-la-eficiencia-en-elsistema-sanitario-Las-ideas-de-los-expertos.pdf [Accessed 23.10.14].

com/2011/01/30/transformational-technologies/ [Accessed 23.10.14].

2 Manary MP, Boulding W, Staelin R, Glickman SW. The patient experience and health outcomes. N Engl J Med 2013;17;368(3):201-3.

6 Reeves, J. Transformational Technologies. Fool 2012. http://www.fool.com/investing/general/2012/08/31/3transformational-technologies.aspx [Accessed 23/10/2014].

3 Lukas, H. Disruptive and Transformational Technologies. Robert H. Smith School of Business, University of Maryland. http://blogs.rhsmith.umd.edu/lucas/ disruptive-and-transformational-technologies/ disruptive-and-transformational-technologies/ [Accessed 23.10.14].

4 Krugman, P. Transformational Technologies. The New York Times 2014. http://krugman.blogs.nytimes.

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5 Savitz, E. Gartner: 10 Critical Tech Trends For The Next Five Years. Forbes 2012. http://www.forbes.com/ sites/ericsavitz/2012/10/22/gartner-10-critical-techtrends-for-the-next-five-years/ [Accessed 23.10.14].

7 Wikipedia. Big Data. http://en.wikipedia.org/wiki/ Big_data [Accessed 23/10/2014].

8 IBM Watson Foundations. IBM big data and information management. http://www-01.ibm.com/software/ data/bigdata/ [Accessed 23.10.14].

9 Zopf DA, Hollister SJ, Ohye RG, Green GE. Bioresorbable Airway Splint Created with a Three-Dimensional Printer. N Engl J Med 2013;368:2043-5.

10 Rouse, M. Software as a Service (SaaS). TechTarget. http://searchcloudcomputing.techtarget.com/definition/ Software-as-a-Service [Accessed 23.10.14].

11 Wikipedia. Internet of Things (IoT). http://en.wikipedia. org/wiki/Internet_of_Things [Accessed 23.10.14].

12 Healthcare IT News. Bring your own device (BYOD). http://www.healthcareitnews.com/directory/byod [Accessed 23.10.14].

13 Kryska S, Grajek M, Rej A. A new weapon in the hands of surgeons. Intelligent sutures. MEDtube. http:// medtube.net/ tribune/a-new-weapon-in-the-hands-of-surgeonsintelligent-sutures/ [Accessed 23.10.14].

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*As demonstrated in vitro ^Defined as the ability to manage exudate, infection and biofilm, as demonstrated in vitro 1. Newman GR, Walker M, Hobot JA, Bowler PG, 2006. Visualisation of bacterial sequestration and bacterial activity within hydrating Hydrober™ wound dressings. Biomaterials; 27: 1129-1139. 2. Walker M, Hobot JA, Newman GR, Bowler PG, 2003. Scanning electron microscopic examination of bacterial immobilization in a carboxymethyl cellulose (AQUACEL™) and alginate dressing. Biomaterials; 24: 883-890. 3. Bowler PG, Jones SA, Davies BJ, Coyle E, 1999. Infection control properties of some wound dressings. J. Wound Care; 8: 499-502. 4. Walker M, Bowler PG, Cochrane CA, 2007. In vitro studies to show sequestration of matrix metalloproteinases by silver-containing wound care products. Ostomy/Wound Management. 2007; 53: 18-25. 5. Assessment of the in vitro Physical Properties of AQUACEL EXTRA, AQUACEL Ag EXTRA and AQUACEL Ag+ EXTRA dressings. Scientific background report. WHRIA3817 TA297, 2013, Data on file, ConvaTec Inc. 6. Physical Disruption of Biofilm by AQUACEL® Ag+ Wound Dressing. Scientific Background Report. WHRI3850 MA232, 2013, Data on file, ConvaTec Inc. 7. Antimicrobial activity and prevention of biofilm reformation by AQUACEL™ Ag+ EXTRA dressing. Scientific Background Report. WHRI3857 MA236, 2013, Data on file, ConvaTec Inc. 8. Antimicrobial activity against CA-MRSA and prevention of biofilm reformation by AQUACEL™ Ag+ EXTRA dressing. Scientific Background Report. WHRI3875 MA239, 2013, Data on file, ConvaTec Inc.

®/™ Indicates trademarks of ConvaTec Inc. ©2014 ConvaTec Inc. AP-014181-MM

Scientific Communication

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to EWMA Journal, based on a presentation given at a free paper session (Free paper session: Quality of life) at the EWMA - GNEAUPP 2014, Madrid

A patient-led approach to product innovation in patient education and wound management

ABSTRACT This paper reports results from a multi-disciplinary industry-academia research partnership whose goal was to conceive, design and prototype solutions for older adults with chronic wounds.

Aim: The aim of the project was to explore the potential enhanced benefits of extended patient involvement in an entire live product development process, from understanding the wound care environment, through needs identification, to solution generation and iteration.

Methods: An action-design research methodology was used to engage with 47 target users and develop design ideas and prototypes. The research was built around a theoretical framework that integrates aspirations and needs of target users with socio-technical systems thinking and innovation management processes.

Results: The design component of the research methodology resulted in the concept design of a wound management education and information system for use by patients and their caregivers. This concept was developed based on observations of and interaction with patients and caregivers. A prototype solution was built and used as a vehicle to gain an understanding of

opportunities, issues, and challenges to be addressed in supporting older adults with chronic wounds and enabling them to maintain and improve their personal wellbeing. This led to the identification of the need for readily available, current wound care information, advice, and support for older people and caregivers.

The design concept was a response to this need. From early evaluations of a prototype implementation, age was identified as not necessarily being a barrier to the use of a technology-based solution; IT skills, confidence, and access to the internet were identified as more important factors.

Outcomes: A prototypical wound care information system was developed that has been evaluated with target users using deliberative panels and home-based evaluations of a prototype implemented on a tablet platform. Wound care solutions focussed on the need to support people in maintaining their personal wellbeing lead to different requirements from those that support wound treatment. By considering wider perspectives, solution providers have opportunities to utilise fewer or re-allocate resources whilst improving user wellbeing by creating user-focussed outcomes that are effective, efficient, and valued by both patient and provider.

INTRODUCTION Policy developments in the UK resulting from the Health & Social Care Act1 prioritise the adoption of a proactive approach to patient involvement in service and product innovation in healthcare. The “user pull” this creates aligns with innovation theories2 that emphasise the importance of understanding user and market needs in addition to technologies that could be used to create solutions. Within industry, the importance of customer insight is increasingly recognised, and growing numbers of companies in the medical technology sector are looking to open innovation as a key approach to drive future growth3. However, currently less than one third of medical technology-based solutions have been co-created with customers or external partners4. 

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Elaine McNichol1

Alison McKay1

Christine Milligan2

Kate Bennett3

Rod Hulme4

Heather Joy5 1 University

of Leeds, Leeds LS2 9JT, UK 2 University of Lancater, Bailrigg, Lancaster LA1 4YW, UK 3 University of Liverpool, Liverpool, Merseyside L69 3BX, UK 4 Smith & Nephew, 15 Adam Street, London, WC2N 6LA 5 Hull City Health Care Partnership CIC, 5 Beacon Way, Hull, HU3 4AE, UK Correspondence: e.mcnichol@leeds.ac.uk Conflicts of interest: None

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In addition to achieving user pull, a further challenge in creating such solutions lies in understanding the organisational context in which solutions are to be introduced.

This is especially the case when introducing information and communications technology (ICT)-based solutions, where failure is often associated with social dimensions of the environment in which they are introduced and with interactions between social and technical dimensions5,6.

With solutions intended for use in patients’ homes, the importance of close interaction with patients and of integrating solutions within the broader patient experience and home environment is even higher. This research used a socio-technical systems framework7 as a means of gaining these insights both in the early stages of the design process and in the evaluation of prototype solutions.

The problem of older adults living with chronic wounds was selected as a case study because of the challenges involved in supporting this population to allow them to live independently, thereby improving their quality of life and wellbeing. Solutions were conceived, designed, and prototyped. The specific focus on development of innovative internet/e-technology-based solutions was identified early in the process, during which patients highlighted the importance of being able to manage, rather than cure, their wounds. The approach used both educated researchers and clinical experts, and addressed issues of both personal wellbeing and clinical health, driven by a philosophy of patient-identified need.

BACKGROUND There is a tension between the primary focus of clinicians, industry, and healthcare organisations with regards to cure and compliance, and the importance to patients of the everyday impact of living with a wound and the requirements of innovations that will address their sense of wellbeing8. At the same time, there is increased recognition within the NHS in the UK, for example, of public and patient involvement both in research and in the design and delivery of services9. This creates a challenge in identifying, hearing, and maintaining the voice of the patient amongst the plethora of multi-professional voices.

These competing commitments informed the rationale for beginning with the patient perspective, thereby ensuring that this perspective was the inspiration for the innovation process, and that it would continue to be involved and influence at critical stages of development.

The importance of user pull in successful innovation processes is increasingly recognised10. ICT-based systems and solutions can provide the “pull” from patients and caregivers for greater innovation by enabling patients and caregivers to make informed choices about which interventions they would like to receive and take responsibility for

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in managing their own care. Patient and caregiver demand is an important driver for the adoption of technology as they become more empowered and more demanding about the kinds of treatment they want. Patients may not be able to specifically articulate an innovation, but they can describe their basic needs and their basic expectations of wound care management solutions. The aim of this project was to explore the potential enhanced benefits of extended patient involvement in an entire live productdevelopment process, from understanding the wound care environment, through needs identification, to solution generation and iteration.

METHOD & RESEARCH PROCESS An action-design research methodology was used11. Core aspects of the methodology were engagement with users through the whole process (before any solutions were proposed) and the use of design sketching and prototyping as a means of quickly exploring and evaluating potential solutions, broadly illustrated in Figure 1.

Figure 1. The design and development process

As preparation for the cycle, a desk-based analysis of patient and other stakeholder needs, informed by a socio-technical systems thinking approach to innovation and management processes5 , was carried out. This was combined with the concept of using design to create self-perpetuating Virtuous Cycles of Wellbeing12. The research team engaged with 47 older people with a focus on the key experience of “living with” a chronic wound.

The more detailed research process, illustrated in Figure 2, began with a study of the problem domain, which included a desk-based study and discussions with wound care professionals, and a literature review of innovation systems in the wound management domain. This ensured that all academic participants had a basic awareness of issues and current practices in the management of wounds.

Two series of half-day workshops were then carried out.

These workshops involved 15 selected urban, communitybased, ambulatory, and wheel-chair bound patients and caregivers with a history of wound care, and an ability to articulate their stories, experiences, and needs gained from

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of community-based patients and caregivers, again, from training they had previously received from the University both urban and rural settings. The prototype was impleof Leeds. The results of this preliminary work, in terms mented as semi-functional software on a hand-held device, of how meaningful it was for patients and their caregivers, in order to allow the patient and caregiver to develop a betwere evaluated at the beginning of the first action design ter feel for a potential live solution. The research took the research workshops. This led to a shared understanding of form of one-to-one or one-to-two interviews, conducted patient and caregiver perspectives on living with a chronic by a project team member, either in the patient’s home or wound and highlighted differences in priorities of different a neutral health-related environment. stakeholders within chronic wound care systems where patients and caregivers place more value on living well With the exception of the Design team (ex-students), all (e.g., no discomfort related to compression stockings and activity was conducted by project team members and asbeing able to wear shoes that are comfortable, aesthetically sociates drawn from the initial academic, health provider, pleasing, and odour free13) rather than healing the wound. and industry participants. Feedback on the process was Outputs from these workshops were in the form of lowobtained from the team members. fidelity prototypes of possible solutions and their pros and cons. Results from the initial study and the workshops were passed to a professional design team to inform the RESULTS development of five concept designs with an IT interface The key results of the project are split into two areas of but with no functionality. These concepts were evaluated focus: in a second series of patient-led workshops held in both 1. The benefits of extended patient and caregiver an urban and a rural environment with ambulatory and involvement in the product development process. wheelchair-bound community-based patients and caregiv2. The final design concept definition as shown in ers less familiar with articulating their needs.

Feedback on both the product solutions and their involvement in the development process was Figure 3.

Based upon the qualitative and quantitative feedback from obtained from the participating patients and caregivers. the workshops, specified concept selection criteria were It can be seen that the final concept was an education and used to select the final concept for further development.

The final result from this phase of the research was the definition of a concept that was then wound management information system informed by isFeedback on both the product solutions and their inimplemented as a prototype that could be evaluated with a wider range of community‐based patients sues that patients and caregivers said were important to volvement in the development process was obtained from and caregivers, again, from both urban and rural settings. The prototype was implemented as semi‐ them. Appropriate expert advice on relevant topic-related the participating patients and caregivers. functional software on a hand‐held device, in order to allow the patient and caregiver to develop a issues was included along with advice on management, The final result from this phase of the research was better feel for a potential live solution. The research took the form of one‐to‐one or one‐to‐two support and personal goal setting, self-monitoring and the definition of a concept that was then implemented reporting of wound profile (self-assessment) capabilities, asinterviews, conducted by a project team member, either in the patient’s home or a neutral health‐ a prototype that could be evaluated with a wider range

related environment.

Understand the problem situation Desk‐based study of wound care user needs & requirements

Discussions with wound care professionals

Literature review of wound management innovation systems

Research results

Preliminary design workshops Design development workshop with patients & carers

Five Professional concept design designs development of concepts

One concept selected for development Professional design development of final concept

Final design concept definition

low fidelity Review problem prototypes understanding with patients & carers

Concept development & evaluation with users in rural settings Prototype development & evaluation with users in urban settings

Figure 2. Flow chart of the research process

Figure 2: Flow chart of the research process

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USING TECHNOLOGY IT skills, confidence, and issues of access were all pertinent to the potential value and impact of the system and were addressed by creating an easy-to-use system that could be deployed on multiple platforms.

Ease of access to expert information and personal wound history as and when needed was seen as empowering and enabling individuals to make decisions and live their lives more independently, an important component of “wellbeing.” However, there was some concern that the technology might mean less input and support from the clinicians and by default more work and responsibility for the management of the wound by the patient. The importance of practitioner contact was emphasised by participants and seen as an enabler for technology adoption. This tension is not limited to wound management; it is also reflected in the wider self-management literature14,15. n The recognition that age need not be a barrier to the use of technology. More important was that the tech nology was described as easy to use, and because it had followed the KISS ‘keep it short and simple’ principle, that it overcame any anxieties individuals may have had due to either a lack of familiarity with IT technol ogy or to lack of physical dexterity.

Among practitioners, views differed between social care and healthcare professionals; social care professional tended to feel that the solution increased empowerment and independence, whereas healthcare professionals tended to hold the view that many older people want to be cared for rather than empowered, and raised concerns that additional monitoring may increase their workloads and that changes in patient and practitioner roles reduced the need for their professional expertise. In discussions considering how these concerns might be addressed, the use of the solution as a “safety net” and a “red flag” system was positively received.

The design was generally regarded as strong, however, in developing it further, a number of technical issues would need to be addressed. For example, methods for caregivers and patients to measure wounds would be needed, as would easy-to-use means of capturing lifestyle-related information, such as nutrition, exercise, and rest. Patients and caregivers recognised the importance of a good diet and exercise, but also identified that the impact of the wound was that “exercise can often be difficult and painful. Anything to help with and monitor exercise would be very beneficial.” (Patient quotation).

ISSUES IDENTIFIED AS IMPORTANT BY PATIENTS INCLUDED: n Trust in the confidentiality of the system, that is, that they could access information as and when they want ed to as well as record information specific to their wound that would only be accessible to themselves and to the healthcare professional. A real fear existed with patients that technology-enhanced care meant that their details could be “hacked.”

DISCUSSION AND FUTURE OPPORTUNITIES The research reported in this paper is part of a wider research initiative with a long-term goal of creating effective and efficient ways of engaging with the users of health and social care systems and with a goal of generating meaningful “user pull” to inform the programmes of change that are being introduced in response to challenges arising from the ageing population. The methodology and process used are outlined in Section 2; a more detailed paper on the

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Figure 3. Design concept

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information on and suggestions for exercise and diet, and links to other potentially useful resources. This addressed a number of issues that patients and caregivers identified and other key stakeholders recognised.

LACK OF READILY AVAILABLE CURRENT WOUND CARE INFORMATION, ADVICE, AND SUPPORT A key benefit to patients and caregivers was that the design overcame a problem described by one patient as “There is not a lot of care information available other than a simple leaflet and basic information from district nurses.” Patient focus groups emphasized that information and advice were not readily available or understandable, and that they were unable to determine if the advice was appropriate for themselves and the care they required. The approach to wound management embedded within the design enables patients to access information when required, as opposed to having to remember it from when it was provided, and allows caregivers and family members to easily access this information.

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methodology is currently in preparation. However, key features of the process are engagement with users through the entire process and the use of design prototypes to help build a shared understanding of both the problem and the proposed solution, and to identify further development opportunities.

A key feature of the action design research methodology is that it benefits both the researcher, by generating new knowledge, and the system users (patients and caregivers), through the resulting solutions. The solution reported in this paper has the potential to lead to a reduction in treatment costs through more appropriate use of clinical appointments. The on-line tool would help inform decision making about whether to request an appointment with a clinician, thereby reducing potentially unnecessary appointments and saving patients time and resources by their not having to either stay at home waiting for a visit or travelling to a clinic. By capturing more holistic information, such as diet, exercise, support, and broader well-being issues, in addition to wound-specific issues, individually-designed treatment plans can be created.

From a process perspective, patient-led identification of needs requiring solutions may identify different priorities to the professionals. Ensuring innovations are fit for purpose and acceptable (i.e., usable, affordable, and wanted) to the patient/caregiver makes them more likely to be adopted, thus speeding up the adoption process of appropriate innovation. Innovations are tailored with patients and caregivers to meet their needs, recognising their unique insights and embedding the inclusion of their perspective throughout the development process to ensure that the end product delivers on the initial identified need.

A “patient-led” approach moves beyond the principle of “patient involvement.”16 It demonstrates a commitment to the concept that the patient has a different but equally valid expertise that should be heard and inform service and treatment innovation. The inclusion of the patient voice at all stages of the innovation process fosters an “on-going” relationship and helps to address the issue

of tokenistic involvement. In this instance, the context has been wound care, but the principle and practice of a patient-led approach to product and service innovation is transferable to other health conditions and contexts.

CONCLUSIONS The aim of the project was to explore the potential enhanced benefits of extended patient involvement in an entire live product development process.

It is clear from the findings that patient and caregiver participation in the product development process brings benefits to understanding the issues that are important to patients’ health and well-being, co-creating potential solutions that address those issues and thereby potentially improve clinical outcomes and use of clinical resources, and tailoring technical requirements to ensure product innovations are fit for purpose in the lived world of the patient as well as in the laboratory.

Involving patients and caregivers in selecting product concepts is not new, but rigorously involving them all the way through the product development process from concept through prototyping and ultimately to marketing is not common and is a practice that this project suggests is advantageous.

Recommendations for practice: n Recognise the patient and caregiver’s expertise of lived

experience and respond to it with the same respect as

to a clinician’s or technologist’s expertise. n Invest time in understanding the patient and caregiver

experience of wounds and innovating new products

and services in response to that insight. n Involve patients and caregivers at the beginning and through

all key stages of innovation development to ensure a good

idea becomes a good product or service.

REFERENCES 1. Health and Social Care Act 2012, c.7. Available at: http://www.legislation.gov.uk/ukpga/2012/7/contents/ enacted (Accessed: 8 January 2015).

6. Clegg C, Shepherd C. The biggest computer programme in the world… ever!’: time for a change in mindset? J Inform Technol 2007;22:212-21.

2. Rogers EM, Medina UE, Rivera MA, Wiley CJ. Complex adaptive systems and the diffusion of innovations. Innov J 2005;10:1-26.

7. Clegg CW. Sociotechnical principles for system design. Appl Ergon 2000;31:463-77.

3. Greenhalgh T, Robert G, MacFarlane F, Bate P, Kyriakidou O. Diffusion of Innovations in Service Organizations: Systematic Review and Recommendations. Milbank Q, 2004;82:581–629.

4. Price Waterhouse Cooper Health Research Unit (2013) Medtech companies prepare for an innovation makeover. www.pwc.com/hriwww.pwc.com/us/ healthindustriestwitter.com/PwCHealth. (accessed 01.05.14) 5. Clegg CW, Gray MO, Waterson PE. The charge of the ‘ByteBrigade’ and a sociotechnical response. Int J Hum Comput Interact 2000;52:235-51.

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8. Anon 2012. International consensus. Optimising wellbeing in people living with a wound. An expert working group review. London: Wounds International.

9. http://www.england.nhs.uk/ourwork/patients/ [Accessed 01.04.15] 10. Or CKL, Karsh BT. A Systematic Review of Patient Acceptance of Consumer Health Information Technology. J Am Med Inform Assoc 2009;16:550– 60.

11. Sein M, Henfridsson O, Purao S, Rossi M, Lindgren R. Action Design Research. MIS Q, 2011;35: 37-56.

13. McNichol E. Involving patients with leg ulcers in developing innovations in treatment and management services. Br J Community Nurs 2014;19(9 Suppl):27-32.

14. Bayliss EA, Steiner JF, Fernald DH, Crane LA, Main DS. Descriptions of Barriers to Self-Care by Persons with Comorbid Chronic Diseases. Ann Fam Med 2003;1(1):15-21.

15. Blakeman T, Protheroe J, Rogers A, Chew-Graham C, Kennedy A. Understanding the management of early-stage chronic kidney disease in primary care: a qualitative study. Br J Gen Pract 2012;62(597):e23342.

16. McNichol ED. Patient Led Innovation in Healthcare - The Value of The User Perspective. Int J Healthc Manag 2012;5(4):216-22.

12. Wartman SA. Toward a virtuous cycle: The changing face of academic health centers. Acad Med 2008;83(9):797–9.

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Scientific Communication

European perspectives on biomaterials for health Fergal Donnelly MD FFPM, Directorate‑General for Research & Innovation, European Commission, B‑1049 Brussels, Belgium.

Correspondence: Fergal.DONNELLY@ ec.europa.eu Conflicts of interest: None

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ABSTRACT Biomaterials for health will become a major focus of European research efforts in the coming years and as part of the Horizon 2020 Framework Programme for Research and Innovation. They will find applications particularly as integral parts of Advanced Therapy Medicinal Products (ATMPs) or, indeed, as complete or parts of Medical Devices. The relevant regulations that govern the marketing of these entities must be taken into consideration when planning research and development, and various incentives and assistance in that regard are available from regulators.

INTRODUCTION Most new technical innovations are directly or indirectly linked to the increasing use of specialised materials, which is forecast to continue rising steadily until at least 2030. The Materials Summit of 2012 brought together a wide range of representatives of the leading industrial and research parties to put together a broad strategic vision of research and development activities for the eventual deployment of specialised materials.

This is intended to generate and maintain the growth, competitiveness, and sustainability of European industry to foster economic activity and employment possibilities along with improved living standards for European citizens1.

At the same time, the bio-based markets with high demand, especially in the field of human healthcare, and with complex yet favourable legislative frameworks have the potential to make a substantial contribution to transform the European economy into one that is more sustainable and competitive in nature. In this context, there is a need for specific partnerships between the private and public sectors, building on corporate responsibility to facilitate greater transparency and accelerated access to new therapeutic interventions in the healthcare field, whilst at the same time rewarding innovation and enhanced industrial competitiveness2.

An integrated approach to research, development, and innovation actions is therefore anticipated3. In this way, novel materials should be devised at the same time as the creation of new products of which the materials are intended to be an integral part. Processing should also be addressed, thus ensuring both the novelty of the developed solution and the rapidity of the solution’s industrial take-up. Among the specific areas of interest that have been identified as priorities for action is biomaterials for medical applications, for EWMA Journal

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Scientific Communication

which a Strategic Roadmap for Research has been proposed1, 4.

BIOMATERIALS FOR HEALTH Biomaterials are examples of Advanced Materials5, because they can offer major improvements in a wide variety of different fields, including healthcare. In the health field, biomaterials often become part of or an entire living structure, either alone or in combination with another biomedical entity in order to perform, augment, or replace a natural function. They might be non-interactive with their environment, such as the case of a heart valve, or possess a more interactive functionality, such as the case of drug-impregnated stents that release pharmaceutical products. More recently, biomaterials have been used to facilitate the operation of Medical Devices6 and Advanced Therapy Medicinal Products (ATMPs)7 over prolonged periods of time.

According to various forecasts and estimates, the size of the global biomaterials market is expected to reach €100 billion by the year 2020, increasing from a mere €20 billion over the preceding 15 years with a Combined Annual Growth Rate (CAGR) of between 10% and 15%. Increased investment of a public and private nature, technological advances, greater scope for the use and deployment of biomaterials, and an ageing population – who are by far the greatest users of biomaterials – are the major factors that will promote the global biomaterials market growth.

However, major deterrents that negatively impact the biomaterials market include immunological and inflammatory reactions, stringent regulatory systems, reimbursement, and the biomechanics issues of fracture, fatigue, and wear. The global biomaterials market is dominated

by North America, followed by Europe, Asia, and the rest of the world. North America is expected to continue to lead the biomaterials market in the years to come, followed by Europe. The European market is characterised by a fragmented picture that affects all sectors: national pricing policies and reimbursements offered by healthcare maintenance organisations, national research and innovation policies, etc.

From a technological perspective, the biomaterials market is expected to experience growth due to large increases in the demand for new products that have to interact with their environment in specifically tailored ways. This especially applies to products that are expected to modify the body’s natural reactions to promote tissue and organ regeneration, the so-called “smart biomaterials”. Currently, this field relies largely on the use of “non-smart” biomaterials, which include the traditional categories of polymers, metals, ceramics, and composites. These only partially fulfill clinical needs by:

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n

Replacing damaged tissues and organs (i.e. medical implants) n Treating diseases through the controlled administration of drugs (i.e. drug carriers) n Facilitating diagnosis and monitoring (i.e. contrast agents and biosensors)

The currently available biomaterials suffer limitations, leading to reduced longevity (medical implants) and a lack of biospecificity (biosensors, drug carriers, and contrast agents).

The need to develop biomimetic and bioresponsive biomaterials is therefore widely recognised, as this approach offers solutions both for Advanced Therapies and for improved longevity of Medical Devices. This will need to be a major research and development focus in the future, with innovation being the key to success. Indeed, the body’s internal environment can be simulated by synthetic materials to support tissue-repair processes and to facilitate the cell-specific recognition processes required for bio-targeted drug delivery or imaging. Likewise, biomimetic, bioresponsive biomaterials are widely recognised as prerequisites for the future implementation of cell-based therapies. Major biomaterial breakthroughs in the coming years should address specific needs, such as the enabling the ability to control the phenotype of mesenchymal stem cells in culture.

The major quantum leap for the short to medium-term future is to move away from merely replacing a natural function towards promotion of the body’s capacity for selfhealing, thereby facilitating the regeneration and renewal of the body’s own functions. This might mean modulating an immune response that already exists in an organism to allow other actions to follow, such as the infiltration of a diseased organ with an Advanced Therapy Medicinal Product (ATMP) or a Medical Device so as to repair damaged tissue. Collectively, the ability of biomaterials to adapt to their environments in a beneficial manner, referred to as biocompatibility, will in no small part determine the success of the therapeutic interventions with which the biomaterials are associated. This particular aspect of interactive or smart biomaterials is expected to be a major area of growth for research and development activities in Horizon 2020 and can help to move research out of the “Death Valley” and into commercially viable solutions.

The rational design of smart biomaterials therefore cannot be considered unless a better understanding is achieved of the in vivo perturbation of the biological environment, drug delivery, the mechanisms of biomaterial degradation and fate, and the control of tissue-biomaterial interaction.

In particular, the importance of controlling any inflammation process has been highlighted in a tissue-regeneration context as being of paramount importance. Research will also need to focus on biomaterials that can be adapted to 55



non-invasive clinical protocols through the concepts of injectability, self-assembly, and bio-responsiveness. This approach is becoming crucial for the diagnosis, management, and treatment of critical pathologies such as neurodegenerative disorders (e.g. Alzheimer’s disease, Parkinson’s disease, and multiple sclerosis) as well as cardiovascular disorders, cancer, diabetes mellitus, and others.

REGULATORY AFFAIRS In undertaking research actions involving biomaterials that will become part of Medical Devices or ATMPs, regulatory requirements should be considered, even in basic research projects in which new biomaterials are developed from zero. This means that possible applications and their implications in terms of regulation should be set out in detail. Regulatory experts should be involved in the basic research activities undertaken by consortia to raise awareness of the implications of research decisions in terms of the regulatory path to be followed.

Regulation should not be looked at in isolation but as a factor contributing to the acceptability to the healthcare system of the products containing smart biomaterials. A clear regulatory path should be set out as a requirement for proposals to be considered for funding. The requirements for evidence of safety and efficacy do not come only from regulators but also from the end users and payers. This comprises the full value chain from “bench to bedside”, including the manufacturing sector, where scaling up of production is an important consideration. As a part of this exercise, it will also be necessary to develop a new and better methodology for standardisation, safety assessment, and clinical evaluation and to help to take appropriate stock of innovative scientific advances as and when they occur. This will not in any way replace the current systems of regulatory approval.

The main regulatory processes that concern Medical Devices and ATMPs are the relevant European regulations currently in force that govern these fields6,7.

n

The new environment of the overall regulatory process for medical devices has important implications for future research and development in the field, including biomaterials.

As a result of this package, several measures will be introduced to ensure the traceability and transparency of the devices and their ingredients, which will have important consequences for the biomaterials that may be a part of the devices. They will be required to bear a European Unique Device Identification (UDI), identifying the specific product type and batch, and all operators must be able to identify all those involved in the supply chain. A number of major questions need to be integrated by future research projects with the aim to translate into eventual clinical use. These will concern conformity assessment, surveillance audits, testing, and inspections and also more detailed requirements addressing pre-market clinical evaluation and post-market clinical follow-up. The adaptation of classification rules and risk-classification procedures and the reinforcement of clinical evidence requirements all contribute to a more complex regulatory scenario for medical devices in Europe.

ADVANCED THERAPY MEDICINAL PRODUCTS In the case of Advanced Therapies (and the biomaterials that are parts thereof ), which is the larger of the two fields of potential application, Small and Medium-sized Enterprises (SMEs) that develop these products for human or veterinary use may avail themselves of various incentives that are provided by the European Medicines Agency (EMA), which regulates their marketing in the EU. These comprise: n

n

MEDICAL DEVICES In the field of Medical Devices, the European Commission adopted a package on innovation in health on 26 September 2012, consisting of :

n

n

n

The Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers, and healthcare professionals8 n The Proposal for a Regulation of the European Parlia ment and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) Nº 178/2002 and Regulation (EC) Nº 1223/20099 56

The Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices10

n

n

Administrative and procedural assistance from the SME office Fee reductions for procedures in the pre and postmarketing authorisation phases, including scientific advice, inspections, line extensions, and variations Fee exemptions for certain administrative services of the EMA Deferral of the fee payable for an application for marketing authorisation or related inspection Conditional fee exemption when scientific advice is followed and a marketing authorisation application is not successful Assistance with translations of the product-information documents submitted in the application for marketing authorisation

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n

Waiver of the MedDRA licensing fee when registering with EudraVigilance; this is only available for micro or small-sized enterprises and not for medium-sized enterprises n Inclusion in the public SME register

These incentives can include a 90% reduction in the total applicable fee charged for scientific advice given regarding applications for ATMPs for human use, a 90% reduction to the total applicable fee for non-orphan medicinal products, and either a deferral of the total applicable fee or a conditional fee exemption for an application for a Marketing Authorisation. Further details are available from the EMA11.

WOUND HEALING Biomaterials are used most frequently as part of medical devices, for example, as fracture-fixation devices, internal tissue sealants, surgical haemostats, adhesion barriers, and skin substitutes. Collectively, this domain is expected to be one of the better performers in terms of market growth, with an expected overall combined annual growth rate in the region of 17.8% in the five years ending in 2017.

Plastic surgery and the increase in diabetic ulcers, resulting from ageing and diabetic populations, are the main drivers for this growth. Interestingly, this growth is expected to be greatest not in North America or Europe, but rather in Asia12.

One of the fields for ATMPs is tissue engineering, which is expected to be the focus of new developments in wound healing in the coming years. Biomaterials that facilitate its operation are therefore expected to enjoy a significant upsurge in demand for use in applications where skin and tissue regeneration is desirable. A particularly interesting example of this is chitin, which has high biocompatibility along with a wide range of potential functions, such as accelerated skin repair, immunostimulation, and the stabilisation of drug components intended for delivery.

Another example of an Advanced Therapy that will require similar biomaterials for their effective deployment and use in wound healing is stem cell therapy, which is presently largely confined to autograft use in emergency situations when other solutions are not available.

Given the fragmented nature of European research activities, an integrated approach at the European level is crucial to overcome the new technical challenges that lie ahead and to take advantage of the consequent possibilities for market growth and expansion. The various stakeholders who are involved from research through innovation and eventual market placement will need to be pooled to allow for the increased up-scaling of production and financial risk sharing and the simultaneous optimisation

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of the use of available knowledge and resources. A better focus on research and development priorities through the definition of a strategic research agenda in consultation with stakeholders would thereby ensue. A more competitive private sector to drive economic growth can flourish.

Within this context, there could be the means to address topics such as the regulation and standardisation that require a neutral/multi-stakeholder environment. This will provide for better long-term benefits at the bedside, in the form of shorter waiting times for new therapeutic interventions, that reflect the best of the state of the art at an affordable price, not just for patients but also for healthcare systems overall.

EDUCATION & TRAINING The need for and imminent arrival of smart biomaterials for health pose a particular challenge in the field of education and training, which is somewhat unprecedented in that it requires a combination or merging of research efforts of a clinical nature with those of a more fundamental or laboratory-based nature. This means the development of a broadly accepted career path, based on defined cognitive learning alongside on-the-job experience, for both physicians and non-physicians to become a registered specialist in biomedicine. There is also a need for the acquisition of other skills of a non-scientific nature, such as those in economics, regulatory affairs, ethics, management, business administration, and law. In addition, the structure of undergraduate medical degree courses is such that there is little or no time dedicated to the acquisition of research skills. This contrasts sharply with the post-graduate sphere, whether clinical or non-clinical, where a major emphasis is placed on carrying out and eventually publishing research in order to acquire credibility in a given therapeutic field.

The main obstacles that need to be overcome are: n Design appropriate curricula with appropriate oppor tunities for interdisciplinarity as well as the possibility of research as a long-term career option. n

n

Modernise resources and strategies to reflect new developments and challenges related to healthcare systems, which can thereby be rendered more attractive for medical researchers.

Facilitate the mutual recognition of degrees and diplomas, thereby fostering better international collaboration, while at the same time maintaining the highest possible clinical and quality standards.

n

Improve co-operation between academia and the

î&#x201A;Š

industrial and clinical sectors to facilitate practical hands-on training.

Academic institutions that offer degrees and diplomas related to medical research in all its forms, whether clinical or non-clinical, should develop more numerous and more active connections with a wide variety of public and private stakeholders, both in their immediate regional environment and worldwide. These would comprise large and small industrial companies, healthcare institutions, regulatory bodies, public administrations, research institutes, and all other stakeholders with an interest in the research and production of biomaterials for health. Common and internationally accepted principles regarding research integrity can help to devise appropriate principles in this regard, such as the Marie Curie Actions, the ERASMUS Student Exchange programme, and various activities of the European Science Foundation, which should be continued and expanded. This would result not only in greater mobility and career choices but also in the acquisition of practical skills and the facilitation of better responses to the challenges that lie ahead.

In this regard, a major objective for Europe should be the mutual recognition of post-graduate degrees and diplomas, along the same lines as those used for undergraduate qualifications at present, which would preferably be endorsed by a recognisable pan-European higher education authority. This should be based upon commonly developed standards for the global recognition of credentials along with the development of a pan-European career-tracking scheme that can support the development of world-class quality standards in the field of biomaterials research. Not only will this support and consolidate the classification and standardisation the different types of new and emerging biomaterials, but it will also testify to the excellence and

overall competitiveness of European research institutions and researchers and their mobility within the EU. Continuous professional development programmes for senior medical researchers (i.e. those in pre-clinical disciplines) as well as those in applied medical fields would necessarily become part of this exercise.

The final overall product or deliverable would be an internationally recognised MD-PhD diploma. This would comprise the foregoing scientific and non-scientific elements as well as practical hands-on experience, leading to the production of a memoir supervised and reviewed by experts in the relevant pre-clinical and clinical fields that would certify the results of the research carried out. Greater mobility and career choices can therefore be expected, as well as greater potential use of the practical skills thus acquired.

CONCLUSIONS The ultimate challenge to be addressed in the research and development of biomaterials for health is the integration required to overcome the “Death Valley” between laboratory-based research on the one hand and commercially viable solutions that make a positive difference to the lives of patients on the other. Regulatory requirements must be considered, even in those basic research projects in which new biomaterials are developed from the very beginning, as these have implications not just for eventual applications but also advantages and incentives available from regulators which can speed up the development process. This emphasis on the practical application of research to meet major societal challenges will help to improve existing research infrastructures and to make better use of research results. The result will be to further strengthen innovation, develop new activities, and boost the productivity and competitiveness of the European economy.

REFERENCES

1. European Research and Innovation in Materials Science and Engineering: What to change in the future? Report from the Materials Summit in Brussels, 10 September 2012, 2013 Research and Innovation EUR 25606, ISBN 978-92-79-27540-1

biomaterials-roadmap-for-horizon-2020_en.pdf [Accessed 07.04.14]

2. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions An Integrated Industrial Policy for the Globalisation Era : “Putting Competitiveness and Sustainability at Centre Stage” Brussels, 28.10.2010, COM(2010) 614 final 3. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions : “A European strategy for Key Enabling Technologies – A bridge to growth and jobs”, Brussels, 26.6.2012, COM(2012) 341 final 4. Biomaterials For Health - A Strategic Roadmap for Research and Innovation - Horizon 2020, http://ec. europa.eu/research/industrial_technologies/pdf/

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vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals” Brussels, 26.9.2012, COM(2012) 540 final

5. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions : “Preparing for our future: Developing a common strategy for key enabling technologies in the EU”, Brussels, 30.09.2009, COM(2009) 512 final.

9. Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009: Brussels, 26.9.2012 COM(2012) 542 final 2012/0266 (COD)

6. Directive 90/385/EEC, regarding Active Implantable Medical Devices, Directive 93/42/EEC regarding Medical Devices and Directive 98/79/EC regarding In Vitro Diagnostic Medical Devices.

10. Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices (Text with EEA relevance) Brussels, 26.9.2012 COM(2012) 541 final 2012/0267 (COD)

7. Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products (Gene Therapy, Stem Cell Therapy And Tissue Engineering).

11. Explanatory note on fees payable to the European Medicines Agency, 20 March 2014, EMA/800328/2013, Executive Director, European Medicines Agency, London, UK.

8. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions : “Safe, effective and innovative medical devices and in

12. Biomaterials Market – Global Forecasts to 2017, Healthcare Consulting - MarketsandMarkets 2013.

EWMA Journal

2015 vol 15 no 1

Wound Repair and Regeneration publishes translational research, evidence-based clinical investigation, ground-breaking mechanistic studies focused on wound healing and tissue regeneration.

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A randomized controlled trial of larval therapy for the debridement of leg ulcers: Results of a multicenter, randomized, controlled, open, observer blind, parallel group study Elizabeth Mudge, et al.

Guidelines for the prevention of pressure ulcers Joyce K. Stechmiller, et al.

Guidelines for the treatment of pressure ulcers Joanne Whitney, et al.

Interactions between extracellular matrix and growth factors in wound healing Gregory S. Schultz, et al.

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Scientific Communication

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at a free paper session (Free paper session: Pressure Ulcers) at the EWMA · GNEAUPP 2014, Madrid.

Rosie Cameron MBA, BA, Tissue Viability Project Lead, NHS GGC

An eLearning modular approach to pressure ulcer prevention and management: the views of nursing staff

INTRODUCTION Pressure ulcers are a significant burden both financially and in terms of health-related quality of life.

In response to a growing regard for pressure ulcers as preventable causes of harm, the Scottish government has been involved in the ongoing development of comprehensive quality-improvement programmes encompassing standardised pressure ulcer-prevention packages and the adoption by some health boards of a “Zero Tolerance” mantra regarding avoidable pressure damage (NHS HIS 20111.

There is recognition that a key intervention in the successful achievement of this aim is staff education; however, traditional methods of delivery in pre and post registration nursing are not always adequate2-4. Although there is a shortage of literature exploring the application of eLearning in the healthcare setting, proposed benefits include: convenience, flexibility, compatibility with different learning styles, and cost effectiveness, particularly in the delivery of education programmes on a mass level 4,5 HYPOTHESIS/AIM This paper considers the views of nursing staff on the proposed effectiveness of an eLearning education package for pressure ulcer prevention and management interventions in NHS Greater Glasgow and Clyde (NHSGGC).

METHODS In NHSGGC, a modular eLearning education package for pressure ulcer prevention and man

Angela Rodgers BSc Specialist Nursing Paediatric, RGN, Dip HEN Child Branch, Tissue Viability Nurse, NHS GGC

agement was developed by members of the Tissue Viability Team to support staff involved in patient-care delivery and to ensure education on a level that supports the achievement of targeted quality-improvement outcomes. The programme was based upon existing NHSGGC education frameworks and incorporated into LearnPro NHS, a web-based system that records module completion and assessment, and meets the requirements for both mandatory and role-specific training. A small group of nursing staff was randomly selected from across various clinical areas and skill levels, to test the pilot modules prior to implementation. A qualitative questionnaire was used to obtain a formal evaluation of experience upon module completion. The final module content was adapted and implemented according to relevant feedback from the pilot evaluation.

RESULTS The uptake for pilot module completion across NHSGGC was 100% of the pilot group, and informal feedback from clinical staff was largely positive. The majority of staff expressed a favourable attitude towards eLearning as a concept, although a small number reported feeling uncertain about their skills in utilising it fully. The reported barriers to utilising eLearning mainly included barriers associated with resources including: time, computer availability, and lack of IT support. The majority of participants believed the pressure ulcer content of the modules to be relevant and sufficient; however, a small number reported finding the subject matter too basic in relation to their clinical role and level of individual knowledge.

Lynn Welsh MA, BSc (Hon), RGN, Adult Community Vascular Specialist Nurse, NHS GGC

Katrina McGown Adult Acute Tissue Viability Nurse, NHS GGC On behalf of NHS GGC Tissue Viability Service.

NHSGGC Tissue Viability Department Centre for Brain Injuries 70 Commercial Rd Gorbals, Glasgow Scotland G5 0QZ Correspondence: Lynn.welsh@ ggc.scot.nhs.uk Conflicts of interest: None

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CONCLUSION The Tissue Viability Team found eLearning to be a useful supplement to traditional delivery methods of pressure ulcer prevention and management; however, a marked challenge was the delivery of theoretical content that was suitable for clinical staff with varied knowledge and skill sets across a large organisation. Future recommendations for practice include auditing the incidence of pressure damage in NHSGGC to critically analyse the direct impact of eLearning education upon patient outcomes.

ACKNOWLEDGEMENTS Robert McIlreavy and Learn Pro Development Team

REFERENCES 1. Ashton J, Price P. Survey comparing Clinicians’ wound healing knowledge and practice. Br J Nurs 2006;15(9):18-26.

2. Gerkin KL, Taylor TH, Weatherby FM. The perception of learning and satisfaction of nurses in the online environment. J Nurses Staff Dev 2009;25(1):E8-13.

UPCOMING EWMA INITIATIVES Antimicrobial Stewardship in Wound Care Programme The overall aim of the stewardship programme is to reduce inappropriate and overuse of antimicrobials in wound care by promoting, facilitating, and teaching good antimicrobial use practices. The programme builds on three key objectives and program deliverables: n Development of treatment recommendations n A practical guide for implementation of antimicrobial stewardship n Execution of educational events

3. Mazzoleni MC, Maugeri C, Rongoni C, Cantoni A, Imbriani M, Maugeri S. Is it worth investing in online continuous education for healthcare staff? Stud Health Technol Inform 2012;180: 939-43.

4. NHS Health Improvement Scotland (2011) Preventing Pressure Ulcers Driver Diagram and Change Package. http://www.healthcareimprovementscotland.org/ programmes/patient_safety/tissue_viability.aspx {accessed3/12/13}.

5. Stephen-Hayes J. Pre-registration nurses’ views on the delivery of tissue viability. Br J Nurs 2013;22(20):18-23.

Document: Health-Related Quality of Life – the Patient’s Perspective The EWMA Council has recently decided to initiate a project to highlight the importance of evaluating the patient´s HRQoL in relation to wound management.

The primary objective of this project is to develop recommendations for use of the available HRQoL assessment tools for wound care patients.

Document: Oxygen Therapies Guidance The EWMA Oxygen Therapies Guidance Document will provide practice-oriented guidance on the current use of various forms of oxygen therapies for wound treatment.

This will include an overview of the available treatment options, and an assessment of the best available evidence for use.

Finally, the document will explore the main reasons behind the large differences in the use of oxygen therapies for wound healing between the U.S.A. and Europe, and the potential for increasing the use of oxygen therapies in Europe.

Read more about upcoming EWMA initiatives at www.ewma.org.

Debridement: Whose problem is it?

Solutions for patients, purchasers and providers Chairman: Andrew Kingsley, Devon (UK)

Gregory Schultz, Gainesville (USA) “The role of biofilms in wound chronicity” Andrew Kingsley, Devon (UK) “The relationship between the patient, purchaser and provider to meet the challenges of debridement” Trudy Young, Cardiff (UK) “Debridement across all age groups and wound needs using all available resources” www.Lohmann-Rauscher.com

Symposium 14 May 2015, 1:15 – 2:15 p.m.

Room Platinum 1 – 2

Scientific Communication

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at a free paper session (Free paper session: Pressure Ulcers) at the EWMA · GNEAUPP 2014, Madrid.

Major and minor amputation rates: What do they tell us?

INTRODUCTION Any amputation is a major violation of physical integrity and should be prevented. Other than amputation due to trauma, the lower limb is threatened mainly by peripheral arterial disease and neurovascular foot syndrome. Representatives from government health departments and patient organisations across all European countries met with diabetes experts under the aegis of the World Health Organization (WHO) Regional Offices for Europe and the International Diabetes Federation (IDF) in St Vincent, Italy on 10–12 October 1989, and declared a 50% reduction in the rates of limb amputations due to diabetic gangrene as one of the five-year targets1.

There has been an ongoing discussion about whether this target could be achieved, but in recent years some promising data has been published. This manuscript provides a short overview of these recent studies and highlights the differences between the minor and major amputation rates.

PATIENTS AND METHODS To review the literature, we searched PubMed for the words “lower limb amputation”, “major amputation”, “minor amputation”, and “diabetes”. Manuscripts were included in our review if they were published within the last 5 years and reported population-based trends in major amputation rates over a period of years. The reports are summarized in Table 1.

RESULTS Most studies on major amputation report a decrease in the amputation rate. The United States, United Kingdom, Italy, Finland, Sweden, and Germany had similar trends of different sizes. A direct comparison of the figures is difficult and needs to consider the populations included in each analysis. For example, higher amputation rates are reported from the United States Medicare population compared with populations in other countries. The Medicare population includes individuals who are 65 years and older, disabled, or treated by hemodialysis. Thus, within this population the absolute number of amputations is high. Other studies report amputation rates based on the total population or patients with diabetes only. Thus, younger age groups are included in the countries that report lower amputation rates.

In contrast to these countries, studies from Ireland and Spain did not report a decrease in the major amputation rates. Major amputation rates appear to be fixed at a certain level in these countries.

Minor amputation rates are not reported in all included studies, and trends are not consistent with the major amputation rates within a country. Although major amputation rates decreased in the United Kingdom, Finland, Sweden, and Germany, minor amputation rates increased. In

Knut Kröger Vice President of the Initiative of Chronic Wounds, Germany Department of Angiology, HELIOS Klinikum Krefeld, Germany Correspondence: knut.kroeger@ helios-kliniken.de Conflicts of interest: None

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Spain and Ireland, minor amputation rates increased when major amputations rates increased. Only the United Kingdom and Italy had decreasing minor amputation rates.

DISCUSSION Overall, strategies to reduce major amputation rates in patients suffering from diabetes mellitus seemed to be successful in many countries. Moxey et al. previously reviewed the literature for the incidence of lower extremity amputations from 1989 until 2010, and reported significant reductions in the incidence of lower-extremity amputation in specific at-risk populations2. Thus, it is surprising to see that the incidence failed to decrease in some countries in recent years. Doctors and politicians in these countries are well advised to analyse the reasons for this lack of decrease.

In light of the rising prevalence of diabetes mellitus, minor and major amputation rates might represent different aspects of the same problem. Minor amputation rates might mirror the burden of the rising prevalence of diabetes mellitus and the effects of sufficient or insufficient primary prophylaxis of foot lesions in a specific population. Major amputation rates might provide insight into the effectiveness of treatment strategies when a lesion threatens the limb.

Decreasing major amputations rates indicate that an increasing number of patients with a threatened limb are able to obtain optimal treatment to prevent the deterioration of the lesion. Major amputation is conducted only when all prior efforts have failed. Thus, if a foot lesion can be treated effectively with antibiotics, then offloading and revascularisation major amputations will not be necessary.

However, these therapeutic instruments need to reach the affected patient early enough. Thus, a decrease in major amputation rates can be achieved effectively and easily by referring patients to specialised centres early enough.

Such centres have been established in recent years because these centres can earn money from all the procedures that are offered.

Foot lesions in people suffering from diabetes mellitus usually develop outside a medical setting initially, and it is the patient that has to initiate the first step to contact a

specialist. When the patient finally contacts the specialist, part of the toes or forefoot may already be destroyed beyond repair and no medical procedure can restore it. Thus, despite all the available medical procedures, an indication for minor amputation is given at the time the foot lesion is seen for the first time by a specialist. A decrease in minor amputation rates cannot be achieved through specialised centres, because no procedure exists to restore a toe. Minor amputation rates can be reduced only by improving primary prevention. Primary prevention includes the dissemination of information to the affected population, adequate foot wear and foot care, regular foot inspection to identify early lesions and subsequent offloading, optimal glycemic control and weight reduction, and so on. Therefore, the primary prevention of foot lesions is expensive.

It cannot be managed by single specialised centres, but needs to involve all general practitioners and all health services to reach the total population. The patient or the health system has to spend money, and no doctor can earn money offering one specific procedure.

Given these fundamental differences in the reasons for major and minor amputation, the global target in the fight against amputations associated with diabetes mellitus should focus on the reduction in minor amputations.

Although each major amputation that is prevented is a blessing for the patient, major amputation rates only tell us about the advances in medicine associated with some specialists. The reduction in minor amputation rates requires a general change in care for patients suffering from diabetes mellitus to prevent initial lesions.

The reported minor amputation rates can be assumed to underestimate the true rate, as only minor amputations involving surgical procedures are counted in the published literature. A spontaneous demarcation of the distal part of a small toe can result in a dry gangrene that might be removed during a routine dressing change. Thus, an unknown but probably high number of patients suffering from foot lesions end up with minor amputations that do not appear in the analysed databases. Therefore, although some authors have reported decreasing minor amputation rates in their countries, these results may not represent the true rate.

REFERENCES 1. Diabetes Care and Research in Europe: The St Vincent Declaration. World Health Organization, 1989 2. Moxey PW, Gogalniceanu P, Hinchliffe RJ, Loftus IM, Jones KJ, Thompson MM et al. Lower extremity amputations--a review of global variability in incidence.

Diabet Med 2011;28:1144-53.

3. Rowe VL, Lee W, Weaver FA, Etzioni D. Patterns of treatment for peripheral arterial disease in the United States: 1996-2005. JVS 2009;49: 910-7.

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4. Goodney PP, Beck AW, Nagle J, Welch HG, Zwolak RM. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations.

JVS 2009;50:54-60.

5. Vamos EP, Bottle A, Edmonds ME, Valabhji J, Majeed A, Millett C. Changes in the incidence of lower extremity amputations in individuals with and without diabetes in England between 2004 and 2008. Diabetes Care 2010;33:2592-7

6. Buckley CM, Kearney PM, Ali F, Bhuachalla CN, Casey C, Roberts G et al. Concordance studies between hospital discharge data and medical records for the recording of lower extremity amputation and diabetes in the Republic of Ireland. BMC Res Notes 2013;6:148.

7. Almaraz MC, GonzĂĄlez-Romero S, Bravo M, Caballero FF, Palomo MJ, Vallejo R et al. Incidence of lower limb amputations in individuals with and without diabetes mellitus in Andalusia (Spain) from 1998 to 2006.

Diabetes Res Clin Pract 2012;95:399-405.

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Country, Study UNITED STATES Rowe et al., 20093 Goodney et al., 20094

Patients

Period

Major Amputation Rates

Nationwide inpatient sample (age ≥ 18 years) Medicare population (age ≥ 65, disabled, or on hemodialysis)

1996 2005

30.8% to 21.8% of all acute admissions for PAD* 263 to 188 per 100,000 insured

UNITED KINGDOM National hospital activity Vamos et al., data 20105 (age > 16 years)

1996 2006

Minor Amputation Rates

n.r.

n.r.

2004 2008

118 to 102 per 100,000 people with diabetes

157 to 149 per 100,000 people with diabetes

Hospital In-patient enquiry (age ≥ 16 years)

2005 2009

47.9 to 48.0 per 100,000 people with diabetes

96.2 to 127 per 100,000 people with diabetes

Andalusian Health Service (age ≥ 30 years) Lopez-de-Andres et National hospital discharge data al., 20118

1998 2006 2001 2008

14.9 to 14.9 per 100,000 people with diabetes ≥ 30 years 7.12 to 7.47 per 100,000 inhabitants in patients with type 2 diabetes

13.1 to 14.3 per 100,000 people with diabetes ≥ 30 years 9.23 to 10.97 per 100,000 inhabitants in patients with type 2 diabetes

ITALY Lombardo et al., 20149

National Hospital Discharge Record database

2001 2010

114.5 to 79.3 per 100,000 people with diabetes

168.8 to 161.1 per 100,000 people with diabetes

Nationwide registers on hospital discharges and causes of death

19972007

13.6 to 9.3 per 100,000 person-years in patients with diabetes

11.0 to 13.5 per 100,000 person-years in patients with diabetes

SWEDEN Larsson et al., 200811

Several sources of information

1982 2001

16 to 6.8 per 100,000 inhabitants with diabetes

4.7 to 6.5 per 100,000 inhabitants with diabetes

GERMANY Kröger et al., 201412

National hospital discharge data

2005 2011

23.3 to 17.7 per 100,000 inhabitants

35.0 to 41.8 per 100,000 inhabitants

IRELAND Buckley et al., 20126

SPAIN Almaraz et al., 20127

FINLAND Winell et al., 201310

* Peripheral arterial disease

8. López-de-Andrés A, Martínez-Huedo MA, CarrascoGarrido P, Hernández-Barrera V, Gil-de-Miguel A, Jiménez-García R. Trends in lower-extremity amputations in people with and without diabetes in Spain, 2001-2008. Diabetes Care 2011;34:1570-6 9. Lombardo FL, Maggini M, De Bellis A, Seghieri G, Anichini R. Lower extremity amputations in persons with and without diabetes in Italy: 2001-2010. PLoS One. 2014;9:e86405.

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10. Winell K, Venermo M, Ikonen T, Sund R. Indicators for comparing the incidence of diabetic amputations: a nationwide population-based register study. Eur J Vasc Endovasc Surg 2013;46:569-74.

11. Larsson J, Eneroth M, Apelqvist J, Stenström A. Sustained reduction in major amputations in diabetic patients: 628 amputations in 461 patients in a defined population over a 20-year period. Acta Orthop 2008;79:665-73.

12. Kröger K, Moysidis T, Feghaly M, Schäfer E, Bufe A; on behalf of the Initiative Chronische Wunden e.V., Germany. Association of diabetic foot care and amputation rates in Germany. Int Wound J 2014;4.

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Organ der Deutschen Gesellschaft für Phlebologie Organ der Schweizerischen Gesellschaft für Phlebologie, Bulletin de la Société Suisse de Phlébologie

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Scientific Communication

adrid · Spain

EWMA n GNEAUPP 2014 Submitted to the EWMA Journal, based on a presentation given at The European Society for Clinical Nutrition and Metabolism (ESPEN) Guest Session: Obesity and wound management: The role of nutrition at the EWMA - GNEAUPP 2014, Madrid

Wound risk and prevention in obesity: The role of nutrition INTRODUCTION Obesity is a worldwide problem, not only because of its serious medical comorbidities but also due to its increasing prevalence. It has recently been estimated that the prevalence of obesity has nearly doubled since 1980; 35% and 11% of adults older than 20 years of age are now overweight or obese, respectively, and 65% of the world’s population live in nations in which people who are overweight or obese are more likely to die than people who are underweight1. Therefore, a growing number of obese people will need medical assistance. The purpose of this short review is to address the nutritional aspects of wound risk and prevention in obese people.

WOUND RISK FACTORS IN OBESE PEOPLE Obese people often have several wound risk factors, as shown in Table 1.

Some of these may be preventable, but others are not. In addition, obesity may impair the body’s normal reaction to the effects of gravity. Pressure causes the brain to order a positional change to relieve ischemia, but positional changes may be challenging for obese people and their caregivers, leading to increased susceptibility to pressure sores2.

María D. Ballesteros-Pomar MD, PhD Endocrinology and Nutrition Department, Clinical Nutrition Unit.

Complejo Asistencial Universitario de León Altos de Nava s/n 24008 León, Spain.

Correspondence: mdballesteros@telefonica. net Conflicts of interest: None

SKIN DISORDERS IN OBESE PEOPLE Obesity and associated comorbidities increase the likelihood of impaired skin integrity and slow-to-heal wounds. Therefore, obese people are at risk of developing pressure ulcers, perigenital irritant dermatitis due to urinary and/or fecal incontinence, benign (e.g., candidal intertrigo, erythrasma) or more serious (e.g., cellulitis, necrotizing fasciitis) skin infections, venous ulcers, diabetic foot ulcerations, and surgical site infections3.

Obese people face numerous challenges in maintaining their skin integrity4 due to many pathogenic factors5, as shown in Figure 1. Obese people are at risk of delayed wound healing due to reduced oxygen and nutrient perfusion as a result of cardiovascular changes. Furthermore, adipose tissue has a relatively reduced blood supply, leading to inadequate oxygenation.

Hypoventilation is also common in obese individuals, which reduces tissue oxygenation4.

Furthermore, moisture and microorganism collection in the skin folds of obese individuals can also increase the risk of infection and decrease skin integrity. Immobility, friction, and shear due to substantial weight stress the skin’s barrier function. Nutritional aspects also have a central role in the pathogenesis of skin disorders in obese people. In particular, obese people  EWMA Journal

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TABLE 1.

WOUND RISK FACTORS IN OBESE PEOPLE. • Advanced age • Cognitive impairment/altered sensory perception • Hypoxia, infection/sepsis • Intensive care unit experience, especially vent-dependency • Hyperglycemia/diabetes • Inadequate perfusion/oxygenation/ circulation • Reduced mobility and difficult positional changes • Multiple trauma/burns • Pre-operative illnesses/co-morbidities (e.g., cardiovascular disease) Figure 1. Pathogenic mechanisms of wound risk in obese people (adapted from Pierpoint et al.5).

may be malnourished despite their physical appearance.

This issue will be addressed in the present overview, as malnutrition can lead to inadequate protein, vitamins, and nutrients that are essential to wound repair4.

THE ROLE OF VASCULARITY AS A WOUND RISK FACTOR IN OBESE PEOPLE Some recent reviews and studies have addressed the role of vascularity as a wound risk factor in obese people5-7. An inherent decreased vascularity of adipose tissue has been described in obese people, and increased adiposity induces a signalling cascade that positively feeds back to impair angiogenesis and cause chronic low-grade inflammation.

In addition, increased expression of 11β-hydroxysteroid dehydrogenase type 1 (11βHSD1), an intracellular glucocorticoid-amplifying enzyme, has been observed in obese people. As glucocorticoids suppress angiogenesis, the elevated level of 11βHSD1 serves to amplify the inhibitory effects of glucocorticoids. As adipose tissue becomes hypoxic from impaired angiogenesis, hypoxia-inducible factor 1 alpha (HIF1β) levels increase and initiate local inflammation and fibrosis, which further impair the angiogenic process and wound healing. Other microvascular abnormalities linked to obesity include reduced nitrogen oxide availability, which impairs microvascular rarefaction, and prolonged elevation of free fatty acids in the blood due to increased fat mass, which impairs capillary recruitment5.

In surgical wounds, the increased tension on wound edges that frequently occurs in obese people contributes 72

• Some disease states that cause hyper metabolism and increase nutritional risk

to wound dehiscence8. Wound tension increases tissue pressure, reducing microperfusion and the availability of oxygen to the wound. The increase in pressure ulcers or pressure-related injuries in obese individuals is also influenced by hypovascularity, as poor perfusion makes tissue more susceptible to this type of injury. Venous insufficiency is another vascular factor associated with the development of chronic wounds and delayed wound healing5.

OTHER PATHOGENIC MECHANISMS OF WOUND RISK IN OBESE PEOPLE Beyond impaired angiogenesis and vascularity, chronic low-grade inflammation associated with obesity is another important pathogenic mechanism of skin disorders and impaired wound healing. Obesity-related microangiopathy and alterations in immune mediators may lengthen the inflammatory stage of wound healing and leave obese individuals more susceptible to infections.

Oxidative stress has also been linked to obesity, especially abdominal obesity, through a deficiency in adiponectin, an adipocytokine that protects against oxidative stress and inflammation. Low adiponectin levels impair wound healing via two mechanisms: impaired angiogenesis and impaired keratinocyte proliferation and migration, which is a critical process in the re-epithelialisation phase of wound healing4,5. Another aspect of wound healing that is potentially affected by a hypoxic environment in obesity is the capability of fibroblasts to synthesise collagen5.

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DIABETES AND WOUND HEALING IN OBESE PEOPLE Obesity is often associated with metabolic complications, with diabetes being one of the most relevant complications that also has an important role in wound risk and impaired healing. Poor blood glucose control impairs wound healing and increases risk of infection, and the metabolic stress caused by the wound further increases blood glucose.

In diabetic patients, foot ulcers and pressure-related chronic non-healing wounds are always accompanied by hypoxia9, resulting from insufficient perfusion and angiogenesis8. Hypoxia may further increase the early inflammatory response, which prolongs injury by increasing levels of oxygen radicals. Hyperglycemia also increases the production of oxygen radicals, thereby contributing to oxidative stress. The formation of advanced glycation end products under hyperglycemic conditions is associated with impaired wound healing. High levels of metalloproteases found in diabetic foot ulcers and chronic wounds are also associated with tissue destruction and inhibit normal repair processes. Diabetic patients exhibit dysregulated cellular functions leading to inadequate bacterial clearance and delayed or impaired repair, such as defects in T-cell immunity, leukocyte chemotaxis, phagocytosis, bactericidal capacity, and dysfunctional fibroblasts and epidermal cells10. Diabetic neuropathy also contributes to impaired wound healing. Figure 2 shows factors that contribute to impaired healing in individuals with diabetes.

MALNUTRITION AND WOUND HEALING As previously mentioned, obesity does not necessarily imply a good nutritional status. Obese people are sometimes malnourished because of bad nutritional habits or fad diets, but malnutrition is difficult to detect. This paradoxical malnutrition results from a calorie-dense diet that is high in carbohydrates and fats and low in vitamins and minerals5. Many micronutrient and macronutrient deficiencies have been described in obese people11. Among 232 obese individuals studied by Ernst et al12. before bariatric surgery, 12.5% were deficient for albumin, 8.0% for phosphate, 4.7% for magnesium, 6.9% for ferritin, 6.9% for hemoglobin, 24.6% for zinc, 3.4% for folate, 18.1% for vitamin B12, 32.6% for selenium, 5.6% for vitamin B3, 2.2% for vitamin B6, 2.2% for vitamin E, and 25.4% for 25-OH vitamin D. Albumin deficiency and anemia were positively correlated with body mass index (BMI), and 48.7% of the obese people included in the study showed at least one nutritional deficiency. As proper wound healing requires adequate levels of vitamins and minerals5, obese people may be at risk of impaired wound repair.

Therefore, obese people may have depleted lean body mass and protein stores while maintaining high levels of adipose mass and may be deficient in many vitamins and minerals needed for healing. Furthermore, detecting malnutrition is not easy in these individuals, as many nutrition screening tools rely on BMI or percentage weight loss, making it difficult to assess malnutrition. î&#x201A;Š

Figure 2. Potential effects of diabetes on wound healing. MMPs, matrix metalloproteases; ROS, reactive oxygen species; AGEs, advanced glycation end products (adapted from Guo et al.8.

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PREVENTION OF WOUNDS IN OBESE PEOPLE Some preventative measures might decrease the risk of skin breakdown and maximise wound healing in obese people13. It is very important to maintain skin integrity using cleansers, lotions, moisture barrier ointments, and sealants.

Also, patient independence and mobility should be promoted through the use of supplies, equipment, adaptive devices, and rooms designed for obese patients. Special attention should be paid to tube site care, positioning, and stabilisation. Leg elevation and external compression to encourage fluid recirculation is also important to avoid pressure sores. Furthermore, an adequate staff-to-patient ratio significantly helps to prevent sores13.

ROLE OF NUTRITION IN PREVENTING PRESSURE SORES Evidence-based guidelines on pressure ulcer prevention and treatment that have been developed by the European Pressure Ulcer Advisory Panel (EPUAP)14 and the American National Pressure Ulcer Advisory Panel (NPUAP)15 specifically address the role of nutrition in preventing pressure sores. First, general recommendations are made for the screening and assessment of nutritional status of every individual at risk for pressure ulcers, as the early identification and management of undernutrition can prevent pressure ulcer development. The guidelines suggest using any valid, reliable, and practical tool for nutritional screening that is quick and easy to use and acceptable to both the individual and health care worker as well as having a nutritional screening policy in place in all health care settings. The Braden Risk Assessment Scale for predicting pressure ulcer risk includes a nutrition subscale that can be used in the nutrition screening and assessment process16.

The problem for obese people is that any tool based on

body weight may underestimate malnutrition, and there is currently no screening tool validated for obese individuals.

Second, the guidelines propose providing nutritional support to each individual with nutritional and pressure ulcer risks by performing nutritional assessment, estimating nutritional requirements, comparing nutrient intake with estimated requirements, providing appropriate nutrition intervention based on an appropriate feeding route, and monitoring and evaluating nutritional outcome. Individuals with nutritional and pressure ulcer risks should receive at least 30-35 kcal per kg body weight per day, with 1.25-1.5 g/kg/day protein and 1 ml/kcal/day fluid intake. Obese individuals should not be underfed when at wound risk. When estimating their energy needs, the use of adjusted body weight or specific formulae should be considered. In obese people, beware of calories, but maintain or increase protein supply.

Third, a specific recommendation is to offer highprotein mixed oral nutritional supplements and/or tube feeding in addition to the usual diet to individuals with nutritional and pressure ulcer risks. This recommendation is based on a systematic review and meta-analysis showing a 25% reduction in pressure ulcer development in at-risk patients with high-protein oral nutritional supplements (250-500 kcal/day) compared to routine care17. Obese people should not be excluded from this recommendation when they are either malnourished or at high nutritional risk. A decision tree on nutrition in pressure ulcers prevention and treatment has been published by EPUAP14.

In conclusion, obesity itself should be recognised as a relevant risk factor for wounds, even more so if complicated by diabetes or cardiovascular disease. Also, as obese people may be malnourished, nutritional assessment and management, as in any other at-risk patient, is vital for wound prevention.

REFERENCES

World Health Organization. Obesity and Overweight.

Fact sheet N°311. Reviewed May 2014. Available at:http://www.who.int/mediacentre/factsheets/fs311/en/ Accessed July 20,2014.

pathy, hypertension, and insulin resistance. Circulation.

2004;109(21):2529-35. Epub 2004 May 10.

Levy BI, Schiffrin EL, Mourad JJ, Agostini D, Vicaut E, Safar ME, Struijker-Boudier HA. Impaired tissue perfusion: a pathology common to hypertension, obesity, and diabetes mellitus. Circulation.

2008;118(9):968-76.

Lowe JR. Skin integrity in critically ill obese patients. Crit Care Nurs Clin North Am 2009;21(3):311-22.

Beitz JM. Providing quality skin and wound care for the bariatric patient: an overview of clinical challenges.

Ostomy Wound Manag. 2014;60(1):12-21.

Trans Tasman Dietetic Wound Care Group - Professional Association. Evidence based practice guidelines for the nutritional management of adults with pressure injuries. 2011. NGC:008729. Available at: http://daa. asn.au/wp-content/uploads/2011/09/Trans-TasmanDietetic-Wound-Care-Group-Pressure-Injury-Guidelines-2011.pdf . Accesssed July 21, 2014.

Guo S, Dipietro LA. Factors affecting wound healing. J Dent Res. 2010;89(3):219-29. Epub 2010 Feb 5.

Tandara AA, Mustoe TA. Oxygen in wound healing— more than a nutrient. World J Surg 2004; 28:294-300.

Sibbald RG, Woo KY. The biology of chronic foot ulcers in persons with diabetes. Diabetes Metab Res Rev 2008;24(Suppl 1):25-30.

Moizé V, Deulofeu R, Torres F, de Osaba JM, Vidal J. Nutritional intake and prevalence of nutritional deficiencies prior to surgery in a Spanish morbidly obese population. Obes Surg. 2011;21(9):1382-8.

Pierpont YN, Dinh TP, Salas RE, Johnson EL, Wright TG, Robson MC, Payne WG. Obesity and surgical wound healing: a current review. ISRN Obes. 2014 Feb 20;2014:638936. de Jongh RT, Serné EH, IJzerman RG, de Vries G, Stehouwer CD. Impaired microvascular function in obesity: implications for obesity-associated microangio

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Ernst B, Thurnheer M, Schmid SM, Schultes B. Evidence for the necessity to systematically assess micronutrient status prior to bariatric surgery. Obes Surg. 2009;19(1):66-73. Epub 2008 May 20.

Mathison CJ.Skin and wound care challenges in the hospitalized morbidly obese patient. J Wound Ostomy Continence Nurs. 2003;30(2):78-83.

Clark M, Schols JM, Benati G, Jackson P, Engfer M, Langer G, Kerry B, Colin D; European Pressure Ulcer Advisory Panel. Pressure ulcers and nutrition: a new European guideline. J Wound Care. 2004;13(7):26772.

Dorner B, Posthauer ME, Thomas D and National Pressure Ulcer Advisory Panel. The Role of Nutrition in Pressure Ulcer Prevention and Treatment: National Pressure Ulcer Advisory Panel White Paper. 2009 NPUAP Nutrition White Paper. Available at: http:// www.npuap.org/wp-content/uploads/2012/03/NutritionWhite-Paper-Website-Version.pdf. Accessed July 24, 2014.

Braden B. The Braden Scale for Pressure Ulcer Prediction. Available at: http://www.bradenscale.com/ images/bradenscale.pdf. Accesed July 25, 2014.

Stratton RJ, Ek AC, Engfer M, Moore Z, Rigby P, Wolfe R, Elia M. Enteral nutritional support in prevention and treatment of pressure ulcers: a systematic review and meta-analysis. Ageing Res Rev. 2005;4(3):422-50.

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More Healing + Less Pain = (That’s all the math I need to know)

Ferris Mfg. Corp. 5133 Northeast Parkway, Fort Worth, TX 76106 USA • +1 817-900-1301 • www.polymem.eu Unless otherwise indicated, all trademarks are owned by or licensed to Ferris. © 2013, Ferris Mfg. Corp., Fort Worth, TX 76106 USA MKL-680 REV-0 0315

EPUAP 2015 18th Annual Meeting of the European Pressure Ulcer Advisory Panel 16 – 18 September 2015 Ghent · Belgium

www.epuap2015.org Venue: Culture and Conference Centre Het Pand

PUTTING THE PRESSURE IN THE HEART OF EUROPE • Early registration deadline 15 June 2015 • Abstract submission deadline 30 April 2015 Organised by the European Pressure Ulcer Advisory Panel and the University Centre for Nursing & Midwifery (Ghent University) in cooperation with EPUAP Business Office office@epuap.org +420 251 019 379

Cochrane Reviews

ABSTRACTS OF RECENT ­COCHRANE REVIEWS Publication in The Cochrane Library Issue 7, 2014

Phototherapy for treating pressure ulcers Chiehfeng Chen, Wen-Hsuan Hou, Edwin SY Chan, Mei-Ling Yeh, Heng-Lien Daniel Lo. Citation: Chen C, Hou WH, Chan ESY, Yeh ML, Lo HLD. Phototherapy for treating pressure ulcers.

Cochrane Database of Systematic Reviews 2014, Issue 7. Art. No.: CD009224. DOI: 10.1002/14651858.CD009224.pub2.

Copyright © 2014 The Cochrane Collaboration.

Published by John Wiley & Sons, Ltd.

ABSTRACT Background: A pressure ulcer is defined as “an area of localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure, or pressure in combination with shear”. The use of phototherapy - that is, light (or laser) used as an adjuvant, non-surgical intervention, with the aim of having a therapeutic effect on healing - has increased recently.

Objectives: To determine the effects of phototherapy on the healing of pressure ulcers.

Search methods: In January 2014, we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid EMBASE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); and EBSCO CINAHL. We did not restrict the search by language or publication date.

Selection criteria: Randomised controlled trials (RCTs) comparing the effects of phototherapy (in addition to standard treatment) with sham phototherapy (in addition to standard treatment), another type of phototherapy (in addition to standard treatment) or standard or conventional treatment alone.

Data collection and analysis: Two review authors assessed studies for relevance and design according to EWMA Journal

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the selection criteria, extracted data and evaluated study quality. The authors made attempts to obtain missing data by contacting study authors. Disagreement was resolved by consensus and discussion with a third review author.

Main results: We identified seven RCTs involving 403 participants. All the trials were at unclear risk of bias.

Trials compared the use of phototherapy with standard care only (six trials) or sham phototherapy (one trial).

Only one of the trials included a third arm in which another type of phototherapy was applied. Overall, there was insufficient evidence to determine the relative effects of phototherapy for healing pressure ulcers.

Time to complete healing was reported in three studies. Two studies showed the ultraviolet (UV) treated group had a shorter mean time to complete healing than the control group (mean difference -2.13 weeks (95% CI -3.53 to -0.72, P value 0.003)). One study reported that the laser group had a longer mean time to complete healing than the control group (mean difference 5.77 weeks; 95% CI -0.25 to 11.79). However, this result should be interpreted with caution, as these were small studies and the findings may have been due to chance. Three studies reported proportions of ulcers healed with a variety of results. One study reported a different outcome measure, and the other two studies had different treatment durations. These variations did not allow us to pool the studies and draw any conclusions as to whether phototherapy is effective or not.

Adverse effects were reported in only two studies that compared phototherapy with control; the risk ratio for adverse events was imprecise. One study reported risk ratio (RR) 0.72 (95%CI 0.18 to 2.80). However, another study reported RR 0.89 (95% CI: 0.71 to 1.12) based on the number of events in each group, rather than the number of people with events. Among five studies reporting the rate of change in ulcer area, three studies found no statistically significant difference between the two groups. Pooling was not undertaken because of differences in outcome measures reported.

The results were based on data from trials with unclear risk of bias for which generation of the randomisation sequence, concealment allocation and blinding of outcome assessors were unclear. No studies reported on quality of life, length of hospital stay, pain or cost.

Authors’ conclusions: We are very uncertain as to the

Sally Bell-Syer, MSc Managing Editor Cochrane Wounds Group Department of Health Sciences University of York United Kingdom Correspondence: sally.bell-syer@york.ac.uk Conflicts of interest: None www.wounds.cochrane.org

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effects of phototherapy in treating pressure ulcers. The quality of evidence is very low due to the unclear risk of bias and small number of trials available for analysis. The possibility of benefit or harm of this treatment cannot be ruled out. Further research is recommended.

Plain language summary Phototherapy for treating pressure ulcers What are pressure ulcers? Pressure ulcers (also called bed sores or pressure sores) are sores on the skin caused by constant pressure or friction. They usually affect people who are immobilised or find it difficult to move themselves, for example the elderly or paralysed. Pressure ulcers frequently occur on bony parts of the body, such as the heels and hips, and also on the coccyx (tail bone). Pressure ulcers do not always heal, and, if they do heal, healing can take a long time.

What is phototherapy? Phototherapy is a treatment in which part of the body is exposed to daylight, a or light of a specific wavelength. It is used for treating a variety of diseases, and may involve lights and lasers. Phototherapy is used to treat pressure ulcers in the hope that it will reduce the time the ulcers take to heal.

The purpose of this review: This review tried to find out whether phototherapy treatment(s) given in addition to standard care (i.e. pressure relief, removal of dead tissue from the wound, infection control and application of dressings) improves healing times for pressure ulcers. Standard care plus phototherapy could be compared against standard care alone, or against standard care plus sham phototherapy, or against standard care plus another type of phototherapy.

Findings of this review: The review authors searched the medical literature up to 7 January 2014, and identified seven relevant medical trials, with a total of 403 participants. Six trials compared the use of phototherapy with standard care only; one trial compared it with standard care plus sham phototherapy. Only one trial included a third treatment group that investigated another type of phototherapy.

Two trials reported the time taken for pressure ulcers to heal completely, and these showed an improvement in healing time for people in the phototherapy group who received treatment with ultraviolet light. However, this result should be interpreted with caution, as these were small, poor quality trials, at unclear risk of bias (i.e. with potentially misleading results), and the findings may have been due to chance. The other trials reported either conflicting results or various measures/time points among trials, which meant that we could not conclude whether or not phototherapy is effective for treating pressure ulcers. Two trials reported incidence of harmful (adverse) effects and noted no significant differences between the phototherapy and standard treatment groups. Four trials provided funding information, two from industry funding, the others from an institutional grant. No studies reported on quality of life, length of hospital stay, pain or cost.

This review identified only a few, small studies provided with insufficient evidence to support the use of phototherapy as a routine treatment for pressure ulcers. More trials will need to be

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conducted before it can be established whether this treatment works and is safe.

Perioperative corticosteroids for preventing complications following facial plastic surgery Edina MK da Silva, Bernardo Hochman, Lydia M Ferreira.

Citation: da Silva EMK, Hochman B, Ferreira LM. Perioperative corticosteroids for preventing complications following facial plastic surgery. Cochrane Database of Systematic Reviews 2014, Issue 6. Art. No.: CD009697. DOI: 10.1002/14651858.

CD009697.pub2.

Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background: Early recovery is an important factor for people undergoing facial plastic surgery. However, the normal inflammatory processes that are a consequence of surgery commonly cause oedema (swelling) and ecchymosis (bruising), which are undesirable complications. Severe oedema and ecchymosis delay full recovery, and may make patients dissatisfied with procedures.Perioperative corticosteroids have been used in facial plastic surgery with the aim of preventing oedema and ecchymosis.

Objectives: To determine the effects, including safety, of perioperative administration of corticosteroids for preventing complications following facial plastic surgery in adults.

Search methods: In January 2014, we searched the following electronic databases: the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase; EBSCO CINAHL; and Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS). There were no restrictions on the basis of date or language of publication.

Selection criteria: We included RCTs that compared the administration of perioperative systemic corticosteroids with another intervention, no intervention or placebo in facial plastic surgery.

Data collection and analysis: Two review authors independently screened the trials for inclusion in the review, appraised trial quality and extracted data.

Main results: We included 10 trials, with a total of 422 participants, that addressed two of the outcomes of interest to this review: swelling (oedema) and bruising (ecchymosis). Nine studies on rhinoplasty used a variety of different types, and doses, of corticosteroids. Overall, the results of the included studies showed that there is some evidence that perioperative administration of corticosteroids decreases formation of oedema over the first two postoperative days. Meta-analysis was only possible for two studies, with a total of 60 participants, and showed that a single perioperative dose of 10 mg dexamethasone decreased

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oedema formation in the first two days after surgery (SMD = -1.16, 95% CI: -1.71 to -0.61, low quality evidence). The evidence for ecchymosis was less consistent across the studies, with some contradictory results, but overall there was some evidence that perioperatively administered corticosteroids decreased ecchymosis formation over the first two days after surgery (SMD = -1.06, 95% CI:-1.47 to -0.65, two studies, 60 participants, low quality evidence ). The difference was not maintained after this initial period. One study, with 40 participants, showed that high doses of methylprednisolone (over 250 mg) decreased both ecchymosis and oedema between the first and seventh postoperative days. The only study that assessed facelift surgery identified no positive effect on oedema with preoperative administration of corticosteroids. Five trials did not report on harmful (adverse) effects; four trials reported that there were no adverse effects; and one trial reported adverse effects in two participants treated with corticosteroids as well as in four participants treated with placebo. None of the studies reported recovery time, patient satisfaction or quality of life. The studies included were all at an unclear risk of selection bias and at low risk of bias for other domains.

Authors’ conclusions: There is limited evidence for rhinoplasty that a single perioperative dose of corticosteroids decreases oedema and ecchymosis formation over the first two postoperative days, but the difference is not maintained after this period.

There is also limited evidence that high doses of corticosteroids decrease both ecchymosis and oedema between the first and seventh postoperative days. The clinical significance of this decrease is unknown and there is little evidence available regarding the safety of this intervention. More studies are needed because at present the available evidence does not support the use of corticosteroids for prevention of complications following facial plastic surgery.

Plain language summary Corticosteroids for preventing complications following facial plastic surgery Complications following facial plastic surgery: Today, facial plastic surgery is one of the most common types of surgery. People frequently chose to have it for aesthetic (beauty) reasons, so doctors need to minimise the unpleasant effects (complications) associated with these procedures. All surgical procedures produce an inflammatory response, which may cause swelling and bruising. Severe swelling and bruising are troublesome for patients, as they delay full recovery.

Why corticosteroids might help: Corticosteroids, more often known as ‘steroids’, are medicines that doctors prescribe to reduce inflammation in a wide range of conditions. They are commonly used in facial plastic surgery to reduce swelling and bruising, though it is not known how efficient or safe they might be.

The purpose of this review: This review tried to find out whether giving corticosteroids around the time of facial plastic surgery reduces swelling and bruising compared to another intervention, no intervention, or a fake medicine (placebo).

Findings of this review: The review authors searched the medi-

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cal literature up to January 2014, and identified 10 relevant medical trials, with a total of 422 participants. Nine of these studies were on people having rhinoplasty (surgery to reshape the nose) and one was on people having a facelift.The trials investigated a variety of corticosteroid medicines, as well as different doses of corticosteroids. People in the studies were assessed for swelling and bruising for up to 10 days after surgery. None of the studies stated the funding source.

There was some low quality evidence that a single dose of corticosteroid administered prior to surgery might reduce swelling and bruising over the first two days after surgery, but this advantage was not maintained beyond two days. One study, with 40 participants, showed that high doses of corticosteroid decreased both swelling and bruising between the first and seventh postoperative days. The usefulness of these results is uncertain and there is currently no evidence regarding the safety of the treatment. Five trials did not report on harmful (adverse) effects; four trials reported that there were no adverse effects; and one trial reported adverse effects in two participants treated with corticosteroids as well as in four participants treated with placebo. None of the studies reported recovery time, patient satisfaction or quality of life.

Therefore, the current evidence does not support use of corticosteroids as a routine treatment in facial plastic surgery. More trials will need to be conducted before it can be established whether this treatment works and is safe.

Chinese herbal medicines for treating skin and soft-tissue infections Yun Fei Wang, Hua Fa Que, Yong-Jun Wang, Xue Jun Cui. Citation: Wang YF, Que HF, Wang Y-J, Cui XJ. Chinese herbal medicines for treating skin and soft-tissue infections. Cochrane Database of Systematic Reviews 2014 , Issue 7 . Art. No.: CD010619. DOI: 10.1002/14651858.CD010619.pub2 .

Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background: Skin and soft-tissue infections (SSTIs) are common infections of the epidermis, dermis or subcutaneous tissue. SSTIs range in severity from minor, self-limiting, superficial infections to deep, aggressive, gangrenous, life-threatening infections.

Some classifications divide SSTIs into ‘complicated’ and ‘uncomplicated’ infections based on clinical severity. Treatments of SSTIs involves antibiotic therapy, surgical debridement or drainage, and resuscitation if required. Sometimes these treatments are limited by high treatment costs, bacterial resistance to antibiotics and side effects, therefore, many people with SSTIs are turning to Chinese herbal medicines to treat this problem.

Chinese herbal medicines are natural substances that have been used for centuries in China where they are generally considered to be effective for SSTIs. Some Chinese herbal medicines have been shown to have antibacterial and anti-inflammatory properties, although a few herbal medicines have been reported to 

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have side effects. Therefore there is a need to review the current clinical evidence systematically to inform current practice and guide future studies on Chinese herbal medicines for SSTIs. Objectives: To evaluate the benefits and harms of Chinese herbal medicines for treating skin and soft-tissue infections (SSTIs).

Search methods: Searches were not restricted by date, language or publication status. In July 2014 we searched the following electronic databases: the Cochrane Wounds Group Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; Ovid AMED (Allied and Complementary Medicine); and EBSCO CINAHL. Selection criteria: All randomised controlled trials (RCTs) in people with SSTIs that compared Chinese herbal medicines with another intervention or control.

Data collection and analysis: Two review authors screened the literature search results independently; there were no disagreements.

Main results: We identified no RCTs that met the inclusion criteria.

Authors’ conclusions: There is currently no information available from RCTs to support or refute the use of Chinese herbal medicines in treating people with SSTIs. Plain language summary Should Chinese herbal medicines be used in patients with skin and soft-tissue infections?

What are skin and soft-tissue infections? Skin and soft-tissue infections (SSTIs) are common infections of the skin or the tissue beneath the skin. They include impetigo, abscesses, cellulitis, erysipelas, necrotising (flesh-killing) skin infections, infections caused by animal or human bites or by animal contact, and infections after surgery.

Most SSTIs do not require treatment, but heal by themselves.

Some SSTIs are more serious and can become life-threatening, and these need medical treatment.

What are Chinese herbal medicines? Chinese herbal medicines are mostly extracts of plants, or parts of plants, that are used individually, or combined, as medicines. These traditional medicines have been used in China for centuries, and Chinese doctors currently prescribe them to treat SSTIs. Why use Chinese herbal medicines for SSTIs? In the Western world antibiotics are used to treat SSTIs, however antibiotics are expensive, can cause harms (side effects) as well as benefits, are not suitable for all people, and are becoming less effective as bacteria start to develop resistance to them. Alternative treatments need to be identified, and Chinese herbal medicines could provide that alternative.

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The purpose of this review: The aim of this review was to see if medical research showed whether Chinese herbal medicines are an effective treatment for SSTIs. We wanted to compare the use of Chinese herbal medicines with other treatments, or a fake treatment (placebo), to see which produced a better outcome for patients in a particular type of medical study called a ‘randomised controlled trial’.

Findings of this review: We could not find any randomised controlled trials that compared the use of Chinese herbal medicines for treating SSTIs with other treatments or a placebo. Therefore, we cannot support or refute the use of Chinese herbal medicines to treat SSTIs. In future, we hope that randomised controlled trials will be conducted to evaluate the benefits and side effects of Chinese herbal medicines compared with current practice for the treatment of SSTIs. These trials would help people and doctors to decide on the best way to treatment SSTIs.

Publication in The Cochrane Library Issue 8, 2014

Dressings for the prevention of surgical site infection Jo C Dumville, Trish A Gray, Catherine J Walter, Catherine A Sharp, Tamara Page.

Dumville JC, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD003091. DOI: 10.1002/14651858.CD003091.pub2.

Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background: Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured often with sutures, staples, clips or glue. Wound dressings, usually applied after wound closure, provide physical support, protection from bacterial contamination and absorb exudate. Surgical site infection (SSI) is a common complication of surgical wounds that may delay healing.

Objectives: To assess the effects of wound dressings for preventing SSI in people with surgical wounds healing by primary intention.

Search methods: In February 2014 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); The Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); The Health Technology Assessment Database (HTA) (The Cochrane Library); NHS Economic Evaluation Database (NHSEED) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations);

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Ovid EMBASE and EBSCO CINAHL. There were no restrictions based on language or date of publication or study setting.

Selection criteria: Randomised controlled trials (RCTs) comparing alternative wound dressings or wound dressing with no dressing (wound exposure) for the postoperative management of surgical wounds healing by primary intention.

Data collection and analysis: Two review authors performed study selection, risk of bias assessment and data extraction independently..

Main results: Twenty RCTs were included (3623 participants).

All trials were at unclear or high risk of bias. Twelve trials included people with wounds resulting from surgical procedures with a contamination classification of ‘clean’, two trials included people with wounds resulting from surgical procedures with a ‘clean/contaminated’ contamination classification and the remaining trials evaluated people with wounds resulting from various surgical procedures with different contamination classifications. Two trials compared wound dressings with leaving wounds exposed. The remaining 18 trials compared two alternative dressing types. No evidence was identified to suggest that any dressing significantly reduced the risk of developing an SSI compared with leaving wounds exposed or compared with alternative dressings in people who had surgical wounds healing by primary intention.

Authors’ conclusions: At present, there is insufficient evidence as to whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI or whether any particular wound dressing is more effective than others in reducing the rates of SSI, improving scarring, pain control, patient acceptability or ease of dressing removal. Most trials in this review were small and at high or unclear risk of bias. However, based on the current evidence, we conclude that decisions on wound dressing should be based on dressing costs and the symptom management properties offered by each dressing type e.g. exudate management.

Plain language summary: No recommendations regarding type of wound dressing for the prevention of surgical site infection Millions of surgical procedures are conducted globally each year. The majority of procedures result in wounds in which the edges are brought together to heal using stitches, staples, clips or glue - this is called ‘healing by primary intention’. Afterwards, wounds are often covered with a dressing that acts as a barrier between them and the outside environment. One advantage of this may be to protect the wound from micro-organisms, and thus infection. Many different dressing types are available for use on surgical wounds, however, it is not clear whether one type of dressing is better than any other at preventing surgical site infection, or, indeed, whether it is better not to use a dressing at all. We conducted a review of all available, relevant, evidence regarding the impact of dressings on the prevention of surgical site infections in surgical wounds healing by primary intention. The review examined data from 16 randomised controlled trials and found no evidence to suggest either that one dressing type was better than any other, or that covering these wounds with dressings at all was better at preventing surgical

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site infection, or that any dressing type improves scarring, pain control, patient acceptability or ease of removal. It is important to note that many trials in this review were small and of poor quality, at high or unclear risk of bias and there is an overall lack of evidence. Decisions on wound dressing should be based on dressing costs and the need for management of specific symptoms e.g., absorption of exudate.

Publication in The Cochrane Library Issue 11, 2014

Wound drainage following groin dissection for malignant disease in adults David R Thomson, Hazim Sadideen, Dominic Furniss.

Citation example: Thomson DR, Sadideen H, Furniss D. Wound drainage following groin dissection for malignant disease in adults. Cochrane Database of Systematic Reviews 2014 , Issue 11 . Art. No.: CD010933. DOI: 10.1002/14651858.CD010933. pub2 .

Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background: Groin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates, and, if used, the optimum time for drain removal after surgery is also unknown.

Objectives: To assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.

Search methods: In September 2014 we searched the following electronic databases using a pre-designed search strategy: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). In November 2013 we searched Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.

Selection criteria: We considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage in individuals undergoing groin dissection, where the most superior node excised was Cloquet’s node (the most superior inguinal lymph node). No limits were applied to language of publication or trial location. Two review authors independently determined the eligibility of each trial. 

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Data collection and analysis: Two review authors, working independently, screened studies identified from the search; there were no disagreements.

Tissue adhesives for closure of surgical incisions

Main results: We did not identify any RCTs that met the inclusion criteria for the review.

Jo C Dumville, Paul Coulthard, Helen V Worthington, Philip Riley, Mathew Fortnam, Neil Patel, James Darcey, Marco Esposito, Maarten van der Elst, Oscar J F van Waes

Authors’ conclusions: There is a need for high quality RCTs to guide clinical practice in this under-researched area.

Plain language summary: The effects of using drainage tubes after surgical removal of lymph glands from the groin What are lymph glands? Lymph glands are part of the body’s immune system and swell or enlarge when the body is fighting an infection. They are located in a number of places in the body, including the neck, armpits, and groin.

Why remove lymph glands? Surgical removal of the lymph glands found in the groin (the inguinal lymph nodes) is an important part of the treatment for several types of cancer, including melanoma and other types of skin cancer, as well as squamous cell cancer of the penis, vulva and the surrounding skin. Sometimes complications, such as wound infection, bruising (haematoma) or a collection of lymph fluid in the area (seroma), can occur after removal of these lymph nodes.

Why insert drainage tubes after surgery? Surgeons can insert plastic drainage tubes into the area from which the lymph nodes have been removed. These tubes are inserted towards the end of the operation, once the lymph glands have been removed. The aim of the drainage tubes is to drain away any fluid or blood that may collect in the wounds and cause complications. The drains are usually left in place until the amount of fluid draining out of them in a 24-hour period has reduced to a certain volume (typically less than 30 mL to 100 mL), although some surgeons will remove the drains at a particular time point after surgery (this can vary from 1 day to more than 1 week). Patients can remain in hospital while the drain is in place, although many surgeons will let patients leave hospital and have the drain managed on an outpatient basis.

However, it is unclear whether placement of a drainage tube reduces, increases or has no effect on complications following this type of surgery. Furthermore the best timing for removal of drainage tubes is unknown.

The purpose of this review: The aim of this review was to review all randomised clinical trials (RCTs) that have compared what happens to patients who had a drain inserted after removal of the inguinal lymph nodes with patients who did not have a drain.

We also looked for RCTs that examined the effect of removing drains at different times. We searched the medical literature up to September 2014 to gather all the available evidence.

What the review discovered: We did not identify any RCTs that compared what happens when you do or do not use drains after surgery for inguinal lymph node removal and therefore we still do not know if drains are beneficial in this context.

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Citation example: Dumville JC, Coulthard P, Worthington HV, Riley P, Fortnam M, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ F. Tissue adhesives for closure of surgical incisions. Cochrane Database of Systematic Reviews 2014 , Issue 11 . Art. No.: CD004287. DOI: 10.1002/14651858.CD004287. pub4 Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT Background: Sutures (stitches), staples and adhesive tapes have been used for many years as methods of wound closure, but tissue adhesives have entered clinical practice more recently. Closure of wounds with sutures enables the closure to be meticulous, but the sutures may show tissue reactivity and can require removal. Tissue adhesives offer the advantages of an absence of risk of needlestick injury and no requirement to remove sutures later. Initially, tissue adhesives were used primarily in emergency room settings, but this review looks at the use of tissue adhesives in the operating room/theatre where surgeons are using them increasingly for the closure of surgical skin incisions.

Objectives: To determine the effects of various tissue adhesives compared with conventional skin closure techniques for the closure of surgical wounds.

Search methods: In March 2014 for this second update we searched the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.

Selection criteria: Only randomised controlled trials were eligible for inclusion.

Data collection and analysis: We conducted screening of eligible studies, data extraction and risk of bias assessment independently and in duplicate. We expressed results as randomeffects models using mean difference for continuous outcomes and risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes. We investigated heterogeneity, including both clinical and methodological factors.

Main results: This second update of the review identified 19 additional eligible trials resulting in a total of 33 studies (2793 participants) that met the inclusion criteria. There was low quality evidence that sutures were significantly better than tissue adhesives for reducing the risk of wound breakdown (dehiscence; RR 3.35; 95% CI 1.53 to 7.33; 10 trials, 736 participants

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that contributed data to the meta-analysis). The number needed to treat for an additional harmful outcome was calculated as 43.

For all other outcomes - infection, patient and operator satisfaction and cost - there was no evidence of a difference for either sutures or tissue adhesives. No evidence of differences was found between tissue adhesives and tapes for minimising dehiscence, infection, patients’ assessment of cosmetic appearance, patient satisfaction or surgeon satisfaction. However there was evidence in favour of using tape for surgeons’ assessment of cosmetic appearance (mean difference (VAS 0 to 100) 9.56 (95% CI 4.74 to 14.37; 2 trials, 139 participants). One trial compared tissue adhesives with a variety of methods of wound closure and found both patients and clinicians were significantly more satisfied with the alternative closure methods than the adhesives. There appeared to be little difference in outcome for different types of tissue adhesives. One study that compared high viscosity with low viscosity adhesives found that high viscosity adhesives were less time-consuming to use than low viscosity tissue adhesives, but the time difference was small.

This is how life feels to people with EB. Their skin is as fragile as a butterfly’s wing. They have Epidermolysis Bullosa, a painful and currently incurable skin blistering condition. www.debra-international.org

Authors’ conclusions: Sutures are significantly better than tissue adhesives for minimising dehiscence. In some cases tissue adhesives may be quicker to apply than sutures. Although surgeons may consider the use of tissue adhesives as an alternative to other methods of surgical site closure in the operating theatre, they need to be aware that sutures minimise dehiscence. There is a need for more well designed randomised controlled trials comparing tissue adhesives with alternative methods of closure.

These trials should include people whose health may interfere with wound healing and surgical sites of high tension.

Plain language summary: Tissue adhesives for closure of surgical skin incisions. Tissue adhesives or glues are increasingly used in place of stitches (sutures) or staples to close wounds. It has been suggested that tissue adhesives may be quicker and easier to use than sutures for closing surgical wounds. Tissue adhesives carry no risk of sharps injury - unlike needles that are used for sutures - and are thought to provide a barrier to infection. This may mean that they also promote healing, and the need for removal of sutures is avoided.

The researchers searched the medical literature up to March 2014, and identified 33 medical studies that investigated the use of tissue adhesives for closure of wounds. They compared tissue adhesive with another method of closure such as sutures, staples, tape, or another type of tissue adhesive. The main outcomes of interest were whether wounds stayed closed - and did not break down - and whether they became infected. The results of the review showed clearly that fewer wounds broke down when sutures were used. Studies also reported that some types of tissue adhesives might be slightly quicker to use than other types. There was no clear difference between tissue adhesives and the alternative closure methods for cosmetic results or costs.

Results regarding surgeons’ and patients’ preferred skin closure method were mixed.

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Previous Issues Volume 14 Number 2 October 2014 Published by European Wound Management Association

WOUND CARE – SHAPING THE FUTURE

Rf dC

A PATIENT, PROFESSIONAL, PROVIDER AND PAYER PERSPECTIVE

Volume 14, no 2, October 2014 Economic outcomes of a new chronic wound treatment system in Poland Grzegorz Krasowski, Robert Wajda, Małgorzata Olejniczak-Nowakowska Dressings for split thickness skin graft donor sites Dorte P. Barrit, Hanne Birke-Sorensen The utility of pulse volume waveforms in the identification of lower limb arterial insufficiency Jane H Davies, Jane E A Lewis, E Mark Williams The importance of using a nutritional risk analysis scale in patients admitted to continued care Jose M Corrales, Nuria P Gayo, Mª del Carmen P Águila, Almudena M Martín, Ana Ribeiro Neonatal facial pressure ulcers related to non-invasive ventilation Laura Bonell-Pons, Pablo García-Molina, Evelin Balaguer-López, Mª Ángeles Montal, María C Rodríguez Volume 14, no 1, May 2014 Prevalence of pressure ulcers in hospitalized patients in Germany Heidi Heinhold, Andreas Westerfellhaus, Knut Kröger Excess use of antibiotics in patients with non-healing ulcers Marcus Gürgen Regenerative medicine in burn wound healing: Aiming for the perfect skin Magda MW Ulrich Promising effects of arginine-enriched oral nutritional supplements on wound healing Jos M.G.A. Schols Efficacy of platelet-rich p ­ lasma for the treatment of chronic wounds Vladimir N. Obolenskiy, Darya A. Ermolova, Leonid A. Laberko, Tatiana V. Semenova.

Volume 13, no 2, October 2013 Risk assessment scales for ­pressure ulcers in intensive care units: A systematic review with meta-analysis F. P. García-Fernández et al.

Pressure-time integral of elastic versus inelastic bandages H. Partsch, G. Mosti VERUM – A European approach for successful venous leg ulcer healing R. Brambilla et al.

Effect of topical h ­ aemoglobin on venous leg ulcer healing M. Arenbergerova et al.

The effects of an arginine-enriched oral nutritional supplement on chronic wound healing in non-malnourished patients J. Schols et al.

Efficacy of honey gel in the treatment of chronic lower leg ulcers O. Tellechea et al.

Other journals EWMA wishes to facilitate the exchange of information on wound healing in a broad perspective with this section on International Journals.

ACTA

VULNOLOGICA

ORGANO UFFICIALE DELL’ASSOCIAZIONE ITALIANA ULCERE CUTANEE

Volume 12

December 2014

No. 4

CONTENTS 165

187

Infections and pressure sores

A novel methacrylate powder dressing (Altrazeal®) for hard-to-heal wounds. Case report

ORIGINAL ARTICLES

CASE REPORTS

Brenta F., Vischio M., Scalise A., Jaber O., Scevola D., Nicoletti G.

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Evaluation of the efficacy of a preparation containing essential fatty acids and plant extracts in the prevention and treatment of dehydrated skin in diabetic patients Federici A., Federici G.

Vol. 12 - No. 4

Fraccalvieri M., Morozzo U., Salomone M., Ruka E., Fava R.

193

An infected wound secondary to subcutaneous heroin injection: self-management in wound care. Case report Acquaro J., Sales P., Bignamini E.

ACTA VULNOLOGICA

XV

Save the Date for 2015!

Clinical Symposium on Advances in Skin & Wound Care • September 18-21, 2015 • Hyatt Regency, New Orleans, Louisiana

Advances in

SKIN& WOUND CARE ®

The International Journal for Prevention and Healing

www.woundcarejournal.com

C M E

Volume 28 Number 2 February 2015

CLINICAL MANAGEMENT EXTRA Changes in Classifications of Chronic Lower-Limb Wound Codes in Patients with Diabetes: ICD-9-CM Versus ICD-10-CM Jeanne R. Lowe, PhD, RN; Greg Raugi, MD, PhD; Gayle E. Reiber, PhD, MPH; and JoAnne D. Whitney, PhD, RN, CWCN, FAAN

ORIGINAL INVESTIGATIONS What Is the Healing Time of Stage II Pressure Ulcers? Findings from a Secondary Analysis Alvisa Palese, MNS; Saiani Luisa, MNS; Pota Ilenia, BNS, RN; Dario Laquintana, MNS; Giuseppe Stinco, MD; Paola Di Giulio, MNS, RN; and on behalf of the PARI-ETLD Group

Use of Silicone Materials to Simulate Tissue Biomechanics as Related to Deep Tissue Injury Jessica L. Sparks, PhD; Nicholas A. Vavalle, MS; Krysten E. Kasting; Benjamin Long, MS; Martin L. Tanaka, PhD; Phillip A. Sanger, PhD; Karen Schnell, MSN; and Teresa A. Conner-Kerr, PhD

Association of Sociodemographic Factors with Hope for Cure, Religiosity, and Spirituality in Patients with Venous Ulcers Geraldo Magela Salomé, PhD, RN; Sergio Aguinaldo de Almeida, RN; and Lydia Masako Ferreira, MD, PhD

PLUS Payment Strategies • Practice Points • Infolink

Endorsed by

Lippincott Williams & Wilkins

Finnish

Infections and pressure sores Brenta F., Vischio M., Scalise A., Jaber O., Scevola D., Nicoletti G. Evaluation of the efficacy of a preparation con¬taining essential fatty acids and plant extracts in the prevention and treatment of dehydrated skin in diabetic patients Federici A., Federici G. A novel methacrylate powder dressing (Altrazeal®) for hard-to-heal wounds. Case report Fraccalvieri M., Morozzo U., Salomone M., Ruka E., Fava R. An infected wound secondary to subcutaneous heroin injection: self-management in wound care. Case report Acquaro J., Sales P., Bignamini E. Advances in Skin & Wound Care, vol. 28, no 2, 2015 www.aswcjournal.com

English

Use of Silicone Materials to Simulate Tissue Biomechanics as Related to Deep Tissue Injury Jessica L. Sparks, PhD; Nicholas A. Vavalle, MS; Krysten E. Kasting; Benjamin Long, MS; Martin L. Tanaka, PhD; Phillip A. Sanger, PhD; Karen Schnell, MSN; and Teresa A. ConnerKerr, PhD What Is the Healing Time of Stage II Pressure Ulcers?

Findings from a Secondary Analysis Alvisa Palese, MNS; Saiani Luisa, MNS; Pota Ilenia, BNS, RN; Dario Laquintana, MNS; Giuseppe Stinco, MD; Paola Di Giulio, MNS, RN; and on behalf of the PARI-ETLD Group Association of Sociodemographic Factors with Hope for Cure, Religiosity, and Spirituality in Patients with Venous Ulcers Geraldo Magela Salomé, PhD, RN; Sergio Aguinaldo de Almeida, RN; and Lydia Masako Ferreira, MD, PhD Haava, no. 4, 2014 www.shhy.fi Trip skater’s frost bite Heli Kavola The blade of skate is as sharp as knife of chef Immy Berry, Sara Maastovaara Some things just do not work Sirpa Paananen Occasions Piia Grek-Stjernberg Spectrum of wounds in the doctor’s station Ritva Saraste Recognition and come across of a patient with traumatic crisis Päivi Vuokila-Olkkonen Matti’s experience of traumatic crisis Sirpa Tapio Research from the world OCD: baceteriofobia and fear of smithereens Ulla Dunder Hundreds of wounds, skin lacerations and damages challenge the helpers Anu Pukki The care and prevention of malnutrition among the patients with wounds Susanna von Knorring , Kaisa Kajander EPUAP 2014, Stockholm

Volume 13, no 1, April 2013 The Biofilm-forming capacity of s­ taphylococcus aureus from chronic wounds can be useful for determining Wound-Bed Preparation methods Y. Yarets, L. Rubanov, I. Novikova, N. Shevchenko In vitro efficacy of various topical antimicrobial agents against multidrug-resistant bacteria M. Hajská, L. Slobodníková, H. Hupková, J. Koller The mTOR inhibitors and the skin wound healing F. Benhadou, V. del Marmol A review of evidence for negative pressure wound therapy (NPWT) use post spinal surgery R. A. Atkinson, K. J. Ousey, S. Lui, J. B. Williamson A randomized study on the effectiveness of a new pressurerelieving ­mattress overlay for the prevention of pressure ulcers in elderly patients at risk E. Ricci, C. Roberto, A. Ippolito, A. Bianco, M. T. Scalise Motorcycle ride position, venous return, and symptoms of ­chronic venous insufficiency Ellie Lindsay, P. Vowden, K. Vowden, J. Megson

Acta Vulnologica, vol. 12, no 4, 2015 www.vulnologia.it

Italian

Spanish

Helcos, vol. 25, no. 4, 2014 Pressure ulcers epidemiology in Spain in 2013: results from the 4th National Prevalence Survey” Pedro L. Pancorbo-Hidalgo et al.

Variability on the mangment of chronic wounds. What do nurses think about” José Antonio Esperón Güimil et al

The EWMA Journals can be downloaded free of charge from www.ewma.org

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EWMA Journal

2015 vol 15 no 1

EWMA Int. Journal of Lower Extremity Wounds vol. 13, no 4, 2014 http://ijlew.sagepub.com

English Fa ct or : 2.

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Total-pages: 124

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Paper-type: UPM Gloss 70

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international wound journal An international journal for multidisciplinary wound research and practice

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porcine study comparing Therapy to VeraFlo™ Therapy aline, there was 43%* more ranulation after 7 days of therapy.

february 2015 | volume 12 | issue 1

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r medical RESSURE Editor-in-Chief: Professor Keith Harding Editor: Dr Douglas Queen www.systagenix.com

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MEDLINE Listed Available online: wileyonlinelibrary.com/journal/iwj

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JOURNALOF

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In this issue: • Establishing community wound prevalence within an inner London borough • Honey for non-healing leg ulcers • Analysis of microcirculation in sore-prone pressure areas on conventional and anti-decubitus hospital mattresses Official Journal of the

29-11-2014 01:55:26

English journal of wound care

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opus

Difficult Situations Managing Diabetic Foot. Evidences and Personal Views: Is to Operate on Patients With Diabetic Foot Osteomyelitis Old-Fashioned?

Eric Senneville and Sophie Nguyen Confronting a Dramatic Situation: The Charcot Foot Complicated

by Osteomyelitis Luca Dalla Paola Do Diabetic Foot Infections With Methicillin-Resistant Staphylococcus aureus Differ From Those With Other Pathogens?

Besa Zenelaj, Cindy Bouvet, Benjamin A. Lipsky, and Ilker Uçkay Saving the Limb in Diabetic Patients With Ischemic Foot Lesions Complicated by Acute Infection Giacomo Clerici and Ezio Faglia

Pain in chronic venous insufficiency (including venous claudication) M. Stücker; M. Dörler Peripheral arterial occlusive disease (PAOD) The most important differential diagnosis in leg pain C. Jeanneret-Gris Chronic critical ischaemia of the legs T. O. Meier; B. R. Amann-Vesti Neurogenic claudication A. Mehrkens; B. Jeanneret Restless legs syndrome J. Hafner; P. Dziunycz; A.L. Frauchiger; N. Gräni; F. Kaufmann; N. Jaberg-Bentele; C. Luder; M.T. Mohanna; P. Stieger; B. Weber; D.O. Mayer; S. Läuchli; C. Buset Complex regional pain syndrome (CRPS) Previously Sudeck’s atrophy J. Hafner; C. Buset; P. Dziunycz; N. Gräni; F. Kaufmann; N. Jaberg-Bentele; C. Luder; M.T. Mohanna; P. Stieger; B. Weber; D.O. Mayer; S. Läuchli; A.L. Frauchiger Wound pain N. Gräni; C. Buset; P. Dziunycz; A.L. Frauchiger; F. Kaufmann; N. Jaberg-Bentele; C. Luder; M.T. Mohanna; P. Stieger; B. Weber; D.O. Mayer; S. Läuchli; J. Hafner

Journal of Tissue Viability, vol. 23, no 4, 2014 www.journaloftissueviability.com

English

telligence

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Phlebologie, vol. 43, no 6, 2014 www.schattauer.de

German

WC

volume 24. number 1. january 2015

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The monthly international Journal of Wound Care

Measurement of microelectric potentials in a bioelectrically-active wound care device Evaluation of bactericidal effect of antiseptics on bacteria isolated from wounds Clinical evaluation of a next-generation antimicrobial dressing Effect of a tackifying agent on the properties of ceramide 2 hydrocolloid dressings Use of HBOT and a living bilayer skin substitute on a compromised skin flap

Establishing community wound prevalence within an inner London borough: Exploring the complexities A. Hopkins , F. Worboys A quantitative analysis of microcirculation in sore-prone pressure areas on conventional and pressure relief hospital mattresses using laser Doppler fl owmetry and tissue spectrophotometry J. Rothenberger , S. Krauss , M. Held , D. Bender , H.-E. Schaller , A. Rahmanian-Schwarz , M.A. Constantinescu , P. Jaminet Letter to the Editor Honey for non-healing leg ulcers S.S. Tin , V. Wiwanitkit

English

Rane vol. 4, no 1, 2013 www.lecenjerana.com Novel AG /alginate nanocomposites for wound treatments: animal studies Jasmina Stojkovska, et.al Clinical forms of plantar necrotising fasciitis Cedomir S Vucetic, et.al The significance of D - dimer in early diagnosis of deep vein ­thrombosis in coagulation disorder patients (abstract) Ivana Jelic The possibilities of use of dermoscopy as a diagnostic method in chronic venous insufficiency and chronic venous ulceration (abstract) Javorka B. Delic, Vesna Mikulic

Swedish

Sårmagasinet vol. 1, no 1, 2014 www.ntvw.nl

Journal of Wound Care, vol. 24, no 1, 2015 www.journalofwoundcare.com Evaluation of bactericidal effect of three antiseptics on bacteria isolated from wounds D.U.A. Kumara, S.S.N. Fernando, J. Kottahachchi, D.M.B.T. Dissanayake, G.I.D.D.A.D. Athukorala, N.S. Chandrasiri, K.W.N. Damayanthi, M.H.S.L. Hemarathne, A.A. Pathirana A real-life clinical evaluation of a next-generation antimicrobial dressing on acute and chronic woundsl M. Walker, D. Metcalf, D. Parsons, P. Bowler Measurement of microelectric potentials in a bioelectricallyactive wound care device in the presence of bacteria S.S. Park, H. Kim, I.R.S. Makin, J.B. Skiba, M.J. Izadjoo Use of HBOT and a living bilayer skin substitute for a compromised flap with chronic steroid use: a case report A.L. Pistorio, J. Leslie, R.B. Gustavson, R.C. Baynosa The effect of the concentration of tackifying agent on the adhesive and skin protective properties of ceramide 2-containing hydrocolloid dressings M. Kohta, T. Iwasak

SårMAGASINET E n t i d s k r i f t f r å n s å r s j u k s k ö t e r s k o r i Sv e r i g e

Rapport från EPUAP

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NY tidning

Tema: trycksår

SårMagasinet nr 1 2014

Leczenie Ran vol. 11, no 3, 2014

Polish

Protein metabolism in the patients with thermal injury Kucharzewski M, Ryszkiel I, Wilemska-Kucharzewska K, Rojczyk-Gołębiewska E, Pałasz A The evaluation of chosen extracellular matrix enzymes activity during regeneration of experimental thermal injuries Olczyk P, Komosińska-Vassev K, Winsz-Szczotka K, Stojko J, Klimek K, Gajewski K, Olczyk K The speed of healing process of the leg venous ulcer after application of the foam dressing with silver ions – own experience Kucharzewski M, Mieszczańsk P, Wilemska-Kucharzewska K In vitro evaluation of the single and multispecies biofilm prevention capabilities of two wound irrigation solutions and a topical antiseptic Westgate SJ, Cutting KC Lithuanian

Theme Pressure ulcers Focus EPUAP, Stockholm From shame to success, the journey of a geriatric hospital Sit/and position change clinics Paediatric pressure ulcers PUCLAS 3 New Clinical guidelines, pressure ulcers Pressure ulcers in the spinal cord injured Pressure ulcers an African initiative

nr 1 2014

1

Wounds (SÅR) vol. 23, no 1, 2015 www.saar.dk Portrait of the bacteria Pseudoomonas aeruginosa Henrik Pierre Calum Wound care – General management and local competences Jens Fonnesbech Sitting positions that work! Two experienced occupational therapist swill teach nurses and therapists how to build a common language and share specialist skills Jens Fonnesbech Wound support in Central Region Denmark – support function for telemedicine wound assessment Jens Fonnesbech Status on National Telemedicine Wound project Dorthe S. Lassen, Merete H. Jensen “On this principle have I based a practice” Joseph Lister and the early antiseptics.

Adam Bencard

Scandinavian

Lietuvos chirurgija, vol. 14, no 3, 2014 www.chirurgija.lt Endoscopic ultrasound predicts early recurrence of esophageal varices after endoscopic band ligation: a prospective cohort study Masalaite L, Valantinas J, Stanaitis J Successful video-assisted thoracic surgery for pleural empyema Jagelavicius Z, Jovaišas V, Kybartas A, Zilinskas A, et al.

Treatment of local complications that develop after catheterisation through the femoral artery puncture Asakiene I, Cernauskas A, Misonis N, Zabulis V, et al.

Good results with transcutaneous tibial nerve stimulation for advanced chronic constipation treatment Stundiene I, Zeromskas P, Pfeifer J, Valantinas J Neurilemoma of intrathoracal vagal nerve: clinical case Askinis R, Krasauskas A, Zaremba S, Cicenas S

EWMA Journal

2015 vol 15 no 1

Wund Management, vol. 8, no 6, 2014 English abstracts are available from www.mhp-verlag.de

German ISSN 1864-1121

8. Jahrgang

74528

6

2014

Wund

Management Schwerpunktthema: Chronische Wunden und Ernährung

Originalarbeit Effektivität einer azellulären synthetischen Matrix als Ergänzung zur Standardversorgung bei Ulcus cruris venosum und mixtum: Vergleich von klinischen Studiendaten und Routinedaten

Übersicht Bedarf und Einfluss der Ernährung auf die Wundheilung

Pflegelexikon Exsudat – Bedeutung und Bewertung

Cochrane Pflegecorner Frühes versus spätes postoperatives Baden oder Duschen zur Verhinderung von Wundkomplikationen

Dèbridement mit medizinischen Larven – Ein Update

Blickpunkt Bedürfnisorientierte und bedarfsgerechte Ernährung in der stationären Altenhilfe

Images Livedovaskulopathie

Offizielles Mitteilungsorgan Initiative Chronische Wunden e. V. (ICW e. V.) Österreichische Gesellschaft für Wundbehandlung (AWA) Schweizerische Gesellschaft für Wundbehandlung (SAfW) Wundnetz Kiel e. V. Wundverbund Südwest e. V. Wundzentrum Hamburg e. V. Wundzentrum Nord e. V.

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Effectiveness of an Acellular Synthetic Matrix as an Adjunct to Standard Care in Venous and Mixed Leg Ulcers: Comparison of Clinical Study Data and Routine Data M. Augustin*, M. Gutknecht, Z. Anastasiadou, K. Heyer, K. Harding, P. Aldons, H. Edwards, M. Stacey, E.-L. Heinrichs, R. Shannon Larval debridement therapy – an update (Review) K. Protz

EWMA 2015

LONDON

EWMA 2015 Conference in London, UK

By José Verdú Soriano, EWMA Scientific Recorder.

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The 2015 programme will offer guest sessions from several organisations that are active in thematic issues related to wound healing and management.

An International Partner Session will be hosted by EWMA’s American Partner, the Association for the Advance-

EHEALTH IN WOUND CARE -FROM THE PERSPECTIVE OF HEALTH CARE PROFESSIONALS E U R OP EA

The conference theme is WOUND CARE – SHAPING THE FUTURE - A PATIENT, PROFESSIONAL, PROVIDER, AND PAYER PERSPECTIVE, which reflects that the interdisciplinary teamwork and collaboration between patients, professionals, and policy makers are essential for facilitating good practice and providing continuity of care.

This will be even more important in the future, as health care systems throughout Europe have to cope with increasing pressure to demonstrate the efficient and cost-effective use of resources to optimise wound care with the help of innovative procedures and practices. It is imperative that all these perspectives are considered if we are to realise the goal of successful wound management.

Stay informed by visiting the conference website, www. ewma2015.org, to see registration opportunities or obtain further information about the programme. You can also get your updates on EWMA’s social media platforms.

The full-day streams are extremely popular among EWMA conference delegates and will offer more in-depth presentations and discussions within particular fields of knowledge. The EWMA 2015 full-day symposia includes the eHealth symposium, the joint EWMA-BSAC symposium, the joint EWMA-JCN symposium as well as the TVS symposium.

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Expectations for this conference are high, as more than 800 abstracts have been submitted.

The conference offers more than 1,000 scientific presentations by international key speakers, free paper presenters, poster presenters, workshop facilitators, and satellite symposium speakers. A record number of participants (3,400+) are expected, and the exhibition is the largest in the history of EWMA.

ment of Wound Care (AAWC). The title of the session is “AAWC, Your International Partner, Presents: A Global View of Wound Care: Past, Present, and Future.”

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The 25th Conference of the European Wound Management Association (EWMA 2015) will be a historic event in many ways. The scientific programme has expanded significantly and will consist of various key sessions, workshops, lectures, full-day streams, and satellite symposia, with scientists from Europe as well as the rest of the world.

The 2015 conference is organised in cooperation with the Tissue Viability Society (TVS).

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With this symposium, EWMA focuses, for a third time, on the ever-increasing role of eHealth and information and communication technologies (ICT) in health care.

Specifically, the role of eHealth in wound care will be emphasised.

Increasingly, eHealth is being introduced as an important approach to solving the future challenges that our health care systems will face. eHealth solutions are perceived as essential tools to enable the provision of more care outside hospitals and to facilitate interdisciplinary collaboration and communication across units and sectors to optimise continuity of care. We are currently witnessing the rapid development of available technologies, with increasing EWMA Journal

2015 vol 15 no 1

examples of regions and countries where eHealth is already a part of their routine care. This will forever change the way that care is delivered. The hope is that use of these technologies will lead to more responsive care of higher quality and at lower cost. It is now important to understand how this can be achieved.

This year’s eHealth symposium will examine state-of-theart eHealth services that are already in use in wound care, as well as expectations for future health care systems. It will delve into the need for organisational changes and shifts in the roles and responsibilities of patients and healthcare professionals in eHealth implementation and the delivery of eHealth supported care. Finally, the programme will present some of the recent technical developments in this field. The programme will conclude with a wrap-up session that aims to highlight the main conclusions of the day.

This session will also generate a discussion about ways of moving towards the large-scale deployment of high quality eHealth services in wound care.

To guide the audience through these topics, EWMA has invited several leading experts, researchers, and experienced practitioners within the field of eHealth and wound care.

to properly utilise clinical guidelines, and insufficient implementation of basic policies to promote rational use.

Infection is one of the most frequent complications in wound management; consequently, antimicrobial agents are readily used in the treatment of wounds. Alarmingly, it is estimated that approximately 50% of antibiotic use in both outpatient and inpatient settings is inappropriate.

In wound management, the use of topical antimicrobial agents is particularly important, as the misuse of these agents is believed to be as serious as the misuse of orally or intravenously administered antibiotics. EWMA is dedicated to facing this challenge.

To strengthen our knowledge and educational power, we have joined forces with the British Society for Antimicrobial Chemotherapy for this educational event.

EWMA SYMPOSIUM: CHALLENGE YOUR PRACTICE: WOUND MANAGEMENT AND DRESSING SELECTION IN THE COMMUNITY This Nursing in the Community study day will give accessible, practical guidance on understanding, assessing, and managing wounds. The attendees will be able to gain a clear working knowledge of what needs to be done in community care to achieve better outcomes.

JOINT SYMPOSIUM OF BSAC AND EWMA

Combatting antimicrobial misuse in Wound Care The World Health Organization (WHO) has identified key factors that contribute to the general misuse of antimicrobials: diagnostic uncertainty, lack of skills, failure

WORKSHOPS n Skincare of patients with a chronic wound n Improve mobility and independence with high-quality

foot care - SOFTCAST HEEL PROTECTORS n Evidence-based pressure ulcer risk assessment and

implementation in clinical practice n Debridement n Cooperating Organisations Workshop n Meet the experts: Everything you want to know

about Maggot therapy n Biofilm n Podiatry n Nutrition in wound care n Designing a registry of wounds: the how and why n Can Cochrane reviews inform your clinical decision making? n Strategies for engaging students - support from new

technologies in the delivery of education

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Let’s join forces to bring the European wound healing community together in its mission to raise the awareness of wound management and drive the wound management agenda forward across Europe. We look forward to welcoming you in London! www.ewma2015.org

PROGRAMME HIGHLIGHTS KEY SESSIONS n Opening plenary session: Wound care - shaping the future

- A patient, professional, provider, and payer perspective n Living with non-healing wounds. Psychosocial concerns and

quality of life as patient-informed outcomes n Pressure ulcer risk assessment: What do we know today? n Wound care & geriatrics/Dementia in wound care n Palliative wound care – Evidence-based practice for

managing challenging skin lesions n Hard-to-heal wounds – a challenge for all involved n Paediatric wound care n Leg ulcer diagnosis and treatment – addressing the challenges n NPWT - where are we now, what are the controversies? n Guidance document: eHealth in wound care - from

conception to implementation

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EWMA

PROMOTING ANTIMICROBIAL STEWARDSHIP IN WOUND CARE Infection is one of the most frequent complications in wound management and, consequently, antimicrobial agents are readily used in the treatment of wounds. Alarmingly, it is estimated that approximately 50% of antibiotic use in both the outpatient and inpatient settings is inappropriate. It is a well-established fact that inappropriate use and overuse of antimicrobial agents triggers the emergence of resistant bacteria and causes patient harm. Patients with antimicrobial-resistant infections are more likely to experience ineffective treatment, recurrent infection, delayed recovery or even death.

The WHO has identified the following as key factors contributing to the general misuse of antimicrobials1: diagnostic uncertainty, lack of skills, failure to properly utilise clinical guidelines and inadequate implementation of basic policies to promote rational use1. For wound management, the misuse of topical antimicrobial agents is as serious as the misuse of antibiotics administered orally or intravenously.

Antimicrobial stewardship programmes are increasingly advocated as a means to decrease the misuse of antimicrobial agents. Along with infection prevention and control, hand hygiene and surveillance, antimicrobial stewardship is considered a key strategy in local and national programmes to prevent the emergence of antimicrobial resistance and reduce preventable healthcare-associated infections.

EWMA’S ANTIMICROBIAL STEWARDSHIP PROGRAMME Currently, there are no international or coordinated legislative or regulatory mandates designed to optimize the use of antimicrobial therapy through antimicrobial stewardship. Given the societal value of antimicrobials and their diminishing effectiveness due to antimicrobial resistance, EWMA supports broad implementation of antimicrobial stewardship.

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PROGRAMME AIM The overall aim of EWMA’s antimicrobial stewardship programme is to reduce inappropriate use and overuse of antimicrobials in wound care by promoting, facilitating and teaching good antimicrobial practice. With a focus on the health professional’s role in the area of appropriate use of antimicrobials across health care settings, the programme is targeting not only health professionals involved with wound care - doctors, nurses, pharmacists, microbiologists - but it is also reaching out to policy makers, such as clinical administrators or managers at the local, regional or national level. The aim is supported by the following objectives and programme deliverables:

Treatment recommendations n Development and publication of clinical treatment rec ommendations (decision support tools) that can be used to stratify patients with infected wounds into treatment groups at the point of care n Establishment of expert consensus on key elements of evidence-based best practice antimicrobial prescribing n Development of recommendations for specific wound types: diabetic foot ulcers, venous leg ulcers, and pres sure ulcers

Practical guide to implementation of antimicrobial stewardship n Development, publication and dissemination of a prac tical guide to antimicrobial stewardship in wound care n Description of structural and organisational require ments to optimise antimicrobial treatment of wounds across all health care settings

Dissemination & education events Development, planning and execution of an educa- tional curriculum and educational events disseminat- ing treatment recommendations and a practical guide to antimicrobial stewardship n Dedicated symposia at upcoming EWMA conferences n Regional courses on antimicrobial stewardship in coln

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laboration with EWMA Cooperating Organisations and International Partner Organisations n EWMA’s EU advocacy activities As part of the EWMA antimicrobial stewardship programme, BSAC and EWMA will host a joint session on antimicrobial wound management.

THE OBJECTIVES OF THE JOINT EWMA 2015 SYMPOSIUM ARE AS FOLLOWS: n To enlighten the audience about the innovation and best practices in prevention, diagnosis and treatment of wound infections n To educate the audience about the challenges of anti- microbial resistance in wound care n To inspire and prepare the audience to work with and implement antimicrobial stewardship programmes n The symposium is free of charge for all delegates with a valid registration for EWMA 2015.

BRITISH SOCIETY FOR ANTIMICROBIAL CHEMOTHERAPY (BSAC) /EWMA JOINT SYMPOSIUM

Pisa International Diabetic Foot Course, 30 September - 3 October 2015 Pisa, Italy

This 4 day theoretical course & practical training gives participants a thorough introduction to all aspects of diagnosis, management and treatment of the diabetic foot.

Lectures will be combined with practical ­sessions held in the afternoon at the diabetic foot clinic at the Pisa University Hospital.

Lectures will be in agreement with the ­International Consensus on the Diabetic Foot & Practical Guideline on the Management and Prevention on the Diabetic Foot.

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Antimicrobial Stewardship in Wound Management Thursday 14th May, 14:15-17:55 EWMA Conference 2015, London

Management of the Diabetic Foot

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This course is endorsed by EWMA.

Read more about the symposium here: www.ewma2015.org/scientific/bsac-ewma-symposium.html 1. Medicines: rational use of medicines. Fact sheet number 338. 2010, World Health Organization.

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2015 vol 15 no 1

www.diabeticfootcourses.org

EWMA 2016

Bremen

SAVE THE DATES 11-13 MAY 2016 BREMEN 路 GERMANY

www.ewma.org www.deutscher-wundkongress.de www.wund-dach.org

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EHEALTH IN WOUND CARE - OVERVIEW AND KEY ISSUES TO CONSIDER BEFORE IMPLEMENTATION

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A joint document of the Australian Wound Management Association (AWMA), Australia and the European Wound Management Association (EWMA), Europe.

The document is developed in connection with the United4Health project.

Published as an online supplement by the Journal of Wound Care

This document aims to provide wound care clinicians with a rapid and structured overview of the key issues related to the use of eHealth applications (telemedicine and telehealth) within wound care. This includes: n An overview of the terminology and available literature on this topic n Guidance on the methodology for the evaluation of eHealth solutions n A discussion of the potential benefits of eHealth technologies in wound care as well as the possible barriers to their implementation n Recommendations for ensuring a good implementation process n Recommendations for supporting the involvement of wound care professionals in safeguarding that eHealth solutions in wound care meet the needs of patients METHODOLOGY The layout of the document follows the structure and focus areas of the Model for the Assessment of Telemedicine (MAST), which defines crucial items to address in the evaluation of an eHealth application.

The content of the document is developed on the basis of a literature review that identified available documentation for the use of eHealth solutions in wound care. Furthermore, the document draws on various key documents that have been published recently on the general development, evaluation, and implementation of eHealth solutions. These documents include valuable up-to-date information relevant to any group of clinicians who wish to follow and influence the way eHealth solutions are integrated into daily clinical practice.

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FINDINGS AND CONCLUSIONS The literature review revealed that the amount and level of evidence for the use of eHealth applications in wound care remains limited. Some MAST domains have not been examined in any of the available studies. Thus, more research is required to identify the potential benefits and harms to patients as well as the possible challenges related to the implementation of eHealth solutions in wound care.

Zena Moore, Document editor Correspondence: ewma@ewma.org

Potential barriers as well as facilitators for the implementation of eHealth applications into wound care practice are identified in the document, and these may either enhance or impede the implementation process. However, the available research on the use of eHealth care demonstrates patient satisfaction; improved access to health services for all client cohorts, including underprivileged groups; and increased job satisfaction for clinicians.

The document recommends that wound care clinicians who are considering the use of eHealth

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applications in their clinical practice should consult widely and conduct regular evaluations of the outcomes to ensure efficient implementation of these services.

To support this approach, some steps to ensure a good implementation process within a given organisation have been proposed. These steps are synthesised into a three-level model and illustrate the areas demanding specific attention in the different phases, ranging from initial considerations to actual implementation and the use of the system in a clinical practice.

This model is illustrated in Figure 1. A more detailed description of the model is provided in the full document.

This document is published in connection with the United4health project (www.united4health.eu).

Funding programme: ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Commission.

Figure 1: What must be in place during the development and implementation of an eHealth solution.

EWMA CONFERENCE 2015

eHealth Symposium

London · Thursday 14 May & Friday 15 May

eHealth in wound care – from the perspective of the health care professionals

OVERALL OBJECTIVE With this symposium, EWMA focuses, for a third time, on the ever-increasing role of eHealth and information and communication technologies (ICT) in health care in general and wound care in particular.

This year’s eHealth symposium will examine the state of the art of eHealth services already in use in wound care, as well as expectations for future health care systems. It will delve into the need for organisational changes and shifts in the roles and responsibilities of the patients and healthcare professionals in eHealth implementation and delivery of eHealth supported care. Finally, the programme will present some of the recent technical developments in this field. The programme will conclude with a wrap-up session aiming to highlight the main conclusions of the day.

The purpose of the wrap up session is also to generate discussion about ways of moving forward towards the large-scale deployment of high quality eHealth services in wound care.

PROGRAMME THURSDAY 14 MAY 16.55 - 17.55

Key session: Guidance document on eHealth in wound care

FRIDAY 15 MAY 08.00 - 09.30

Remote assessment in wound care: Towards mature solutions and large-scale deployment

10.15 - 11.15

The healthcare system of the future – healthcare without borders

11.15 - 12.15

The organisational dimension of eHealth implementation

12.30 - 13.30

New technologies - new opportunities

14.15 - 15-15

Wrap up session: State of the art of eHealth in wound care

Read more about the symposium programme at www.ewma2015.org/scientific/ehealth-symposium The eHealth symposium is held in connection with the United4health project

www.united4health.eu

EWMA has invited some of the leading experts, researchers, and experienced practitioners within the field of eHealth and wound care to guide the audience through these topics.

EWMA Secretariat · Nordre Fasanvej 113, 2 · DK-2000 Frederiksberg · Denmark · www.ewma.org

EWMA NEWS

NEWS FROM CHRODIS-JA EWMA is an associated partner in the Joint Action on Chronic diseases (CHRODIS-JA) initiative by the European Commission, which has now been working for 1 year. Represented by EWMA council member Prof. Alberto Piaggesi EWMA in particular engages in the work package (WP) 7 which addresses the challenge that the burden of diabetes places on the health systems and individuals. The WP7 will as one of the tasks map data and good practices on prevention of complications of type 2 diabetes – among these diabetic foot ulcers.

During the first year a questionnaire on National Diabetes Plans has been sent out. Currently answers from 21 countries are being processed and a draft report on the contents of various National Diabetes Plans is being prepared. This will be followed by an analysis of the processes for prevention of diabetes and complications used in the European Member States. Ultimately the work will produce a guideline on how to make National Diabetes Plans based on best practises content and process wise.

EWMA will participate in the next meeting of the WP 7 in Rome, 2-3 July, 2015.

EWMA PILOT PROJECT: WOUND CENTRE ENDORSEMENTS With the objective of developing a programme for the EWMA endorsement of wound centres, the EWMA has initiated a pilot project targeting the endorsement of a wound centre at the Beida Hospital in Beijing, China.

A working group comprised of wound care clinicians with experience in developing wound care centres in different European countries will be responsible for defining the criteria and procedures for the endorsement of wound centres. The pilot project, which is led by Prof. Finn Gottrup, will focus on wound centres based inside a hospital, including an in-patient ward. However, EWMA also plans to develop specific criteria for wound centres based outside the hospital.

A set of draft criteria has been developed and will be shared and discussed with the Chinese wound care centre to ensure that the developed criteria match the reality of the centres targeted by the programme and meet the standards defined by EWMA. The pilot project is expected to be finalised in the autumn of 2015.

The members of the working group are: Hubert Vuagnat (Chair), Finn Gottrup, Luc Gryson, Arkadiusz Jawien, and Severin Laüchli.

This project is supported by an unrestricted grant from the Coloplast Access to Health Care foundation.

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LEG ULCER GUIDANCE DOCUMENT The EWMA Leg Ulcer Guidance initiative aims to produce a practical guidance document that may be applicable within different clinical settings for leg ulcer treatment in Europe.

The working group responsible for this project started their initial planning of the project in February 2015, and the final document is planned for launch during the EWMA 2016 Conference in Bremen, Germany, 11-13 May 2016.

The document will be developed in collaboration with the Australian Wound Management Association (AWMA), and the document editors are Peter Franks (UK) and Judith Barker (Australia, AWMA representative). The author group also includes Mark Collier (UK), Georgina Gethin (Ireland), Arkadiusz Jawien (Poland), Severin Läuchli (Switzerland), Christine Moffatt (UK), and Sebastian Probst (Switzerland)

In relation to this initiative, a key session on leg ulcers will be held at the EWMA 2015 conference.

This session will include an outline of the current challenges related to the organisation of treatment, as well as an introduction to the diagnosis and assessment of the different types of leg ulcers, by members of the document author group.

The initiative is supported by unrestricted grants from L&R/Activa and BSN Medical

EWMA Key Session: EWMA Conference 2015, London Leg ulcer diagnosis and treatment – addressing the challenges Thursday 12 May 16:55-17:55

SPECIAL SESSION FOR UNDERGRADUATE STUDENT NURSES DURING THE EWMA 2015 CONFERENCE Based on the success of previous years, a special session intended for undergraduate student nurses will take place during the EWMA 2015 Conference.

There has been such an overwhelming interest from students from all over the UK that the event was already fully booked in early April.

The session will give undergraduate student nurses an introduction to wound management. For the students, this will be a unique setting to receive an introduction to the field of wound management in general and pressure ulcers and diabetic foot ulcers in particular, both on a national and international level.

For the first time, one of the presentations during the session will be given by an undergraduate nurse.

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The presentation will be made by 3rd year nursing student, Charlotte Johnston, who has successfully arranged a pressure ulcer conference at the University of Lincoln and was named “Rising Star of the Healthcare Sector”. Charlotte will talk about her personal motivation and present the topic “Pressure ulcer prevention: what can we do as students?”

Furthermore, representatives from both TVS and EWMA will be represented at the session, and there will be a presentation on international cooperation and career opportunities within the field of wound management.

The session will take place on Wednesday 13 May from 15.30-16.30 pm. www.ewma2015.org EWMA Journal

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EWMA NEWS

DEVELOPMENTS ON THE NEW EWMA GUIDANCE DOCUMENT ON NEGATIVE PRESSURE WOUND THERAPY In 2007, EWMA published a Position Document on “Topical Negative Pressure in Wound Management”.

This document was focused on a single device, which at that time was the main negative pressure wound therapy (NPWT) device available on the market. Since 2007, the NPWT technology has advanced considerably, and a number of new devices and treatment applications have become available.

Against this background, a new EWMA guidance document on NPWT is being elaborated. The document will be published in 2016 and presented at the EWMA 2016 conference in Bremen.

The first meeting of the author group was held at the EWMA Secretariat on Sunday 22 February 2015. Here, the content of the document was discussed and established. Secondly, an industry partner meeting was held, where the document outline was presented and discussed.

Among the major developments coming out of the meeting were: n The decision to include all three types of NPWT within the document: on open wounds, with instilla tion, and over closed incisions. This approach en sures the most broadly relevant document with a reach not seen earlier in the NPWT literature. n Extensive coverage of specific factors and guidance in terms of treatment of wounds with different aeti ologies and within different specialities such as trauma, cardiovascular surgery, and problem wounds. n A special focus from the patient’s perspective.

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A dedicated chapter on organisation, which will deal with the cross-sectional possibilities and barriers including reimbursement structures and implementation.

The EWMA NPWT document author group is comprised of the following experts: n Editor Jan Apelqvist, Immediate Past President, PhD, Dr. med. (Sweden) n Co-editor Christian Willy, Prof. Dr. med. (Germany) n Ann-Mari Fagerdahl, RN, PhD (Sweden) n Malin Malmsjö, Prof. Dr. med. (Sweden) n Alberto Piagessi, Prof. Dr. med. (Italy) n Astrid Probst, RN (Germany) n Peter Vowden, Prof. Dr. med. (United Kingdom) A key session will be held at the EWMA conference in London, which will introduce and discuss important elements from the document. In addition, a range of dissemination and implementation activities is planned following the document presentation at the EWMA Conference in Bremen in 2016, which is expected to strengthen the document’s impact and application.

The initiative is supported by unrestricted grants from Acelity, BSN, Mölnlycke, Smith&Nephew, Spiracur.

EWMA Key session EWMA Conference 2015, London NPWT - Where are we now, what are the controversies?

Friday 15 May 14:15-15:45

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SWAN-iCare The aim of the SWAN-iCare project is to develop a wearable device that allows for the monitoring and personalised management of hard-to-heal diabetic foot ulcers and venous leg ulcers.

One key role of EWMA in the SWAN-iCare consortium is to facilitate the dissemination of information to raise awareness about the project. This year, the annual EWMA conference in London will serve as the central platform to disseminate information about the project to experts in the field of wound care.

EWMA has invited the SWAN-iCare consortium to introduce the project at a symposium dedicated to eHealth from the perspective of the wound care professional. The project will be presented by Prof. Marco Romanelli, MD, PhD, of the University of Pisa.

Members of the SWAN-iCare consortium also will attend the Focus Group meeting at the EWMA conference. The overall aim of the Focus Group meeting is for the SWAN-iCare consortium to obtain input from potential end users regarding the product prototype. To facilitate this process EWMA will feature a panel of wound care clinicians with expertise in the management of diabetic foot ulcers and venous leg ulcers. The Focus Group meeting is seen as a strategic opportunity to gain independent validation and sharpen the product specifications at a critical point of the development phase. www.swan-icare.eu

NEW CONSENSUS GUIDELINES FROM THE INTERNATIONAL WORKING GROUP ON THE DIABETIC FOOT During the 7th International Symposium on the Diabetic Foot, May 20 – 23 in The Hague, Netherlands, the International Working Group on the Diabetic Foot (IWGDF) will launch their IWGDF Consensus guidelines on the management and prevention of the Diabetic Foot.

The guidelines, which are updated once every 4 years by experts on the various aspects of diabetic foot syndrome, include practical and specific guidelines for topics such as: Footwear and Off-loading, Infection, Wound Management, Prevention and peripheral artery disease, Diagnosis and Prognosis.

The recommendations in the specific guidelines are developed through the review of supporting scientific evidence.

The purpose of these documents is to provide guidelines that will reduce the impact of diabetic

foot disease via quality healthcare with considerations for cost and using the principles of evidencebased medicine augmented with expert opinion. The intended audience for these guidelines is healthcare professionals working with patients suffering from diabetic foot syndrome or patients at risk for developing diabetic foot syndrome.

The guidelines are free of charge and published both in print and online at www.iwgdf.org. The guidelines are translated and published in English, French, and Spanish.

The International Symposium on the Diabetic Foot, at which the updated guidelines will be launched, is the world’s largest diabetic foot meeting, bringing together more than 1.200 experts from around the world. See the Symposium program and learn more at www.diabeticfoot.nl. www.iwgdf.org

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EWMA NEWS Organisations

Report from the 6th Pisa International Diabetic Foot Course 2014 Pisa International Diabetic Foot Course 2014

Prof. Alberto Piaggesi Director, Diabetic Foot Section University Hospital of Pisa Correspondence: piaggesi@immr.med.unipi.it www.diabeticfootcourses.org

The 6th International Diabetic Foot Course, “Management of the Diabetic Foot”, was held in Pisa, Italy, 1-4 October 2014.

38 participants from 18 different countries, 12 international faculty members and 16 national faculty members, took part in the 2014 course.

Sharing this experience and interacting with the most recognised international experts in the field were highly valued by the participants.

The Diabetic Foot Course combines theory are practical training. Theoretical lectures were held in the mornings and practical workshops with smaller groups were held in the afternoons in the specialised diabetic foot clinic at the University Hospital of Pisa.

The course finished with a 2-hour long direct transmission from the operating room, where Alberto Piaggesi and his staff performed two operations, which were commented on and discussed live by two faculty members.

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The results of an evaluation survey in addition to general comments from the participants during the course suggested great satisfaction with the outcome of the course, emphasising the benefits of combining practice and theory.

The 7th International Diabetic Foot Course will be held again in Pisa, 30 September-3 October 2015. Additional information is available at www.diabeticfootcourses.org or from the Course Secretariat at info@diabeticfootcourses.org.

Participants and faculty members of the 2014 Course:

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EWMA international Partner Organisation

THE WOUNDCARE KIT -A KEY TOOL FOR WOUND CARE IN A HUMANITARIAN ENVIRONMENT

International organisations (such as UNICEF, HCR, ICRC, and MSF (Doctors Without Borders)) commonly use health or medical equipment kits to quickly respond to the main medical or health situations they encounter during their programmes.

A kit is a set of elements selected for a definite task and assembled in a box. It is designed to enable a quick response during emergency. It must be reliable, relatively cheap and bring rapidly all the elements needed in a definite emergency situation in settings with limited resources.

WAWLC representatives presenting the wound care kit in Toronto 31 Oct 2014: From left: John Macdonald, David Keast, Hubert Vuagnat, Terry Treadwell, Eric Comte.

A wound care kit will consist of a box containing the basic necessary supplies needed to treat wounds at a health centre level.

reduced to 36 items, was set and communicated during the 20th annual conference of the Canadian Association for Wound Care November 2014.

The conception of the actual wound care kits used by different international organisations dates back more than 20 years and does not consider the new knowledge acquired during these last decades in wound care and wound healing.

The next step, beginning right now, is the physical constitution of this new kit. This prototype will allow us to have a better estimate of its volume, weight and price.

Furthermore, it will allow us to think of the packaging.

A new wound care kit encompasses the concept of “advanced wound care” and will be a dynamic tool to: n Provide basic equipment for wound care n Harmonise training with a standardised list of medical goods n Facilitate budget calculation both for fund providers and the organisations themselves n Facilitate deployment in emergency situations n Facilitate negotiations with industrial firms to gain the best commercial conditions Since a little more than two years, a working group of the World Alliance for Wounds and Lymphedema Care (www. wawlc.org), has organised workshops to obtain an expert consensus on the kit content. During two workshops held during EWMA’s 2013 (Copenhagen) and 2014 (Madrid) conferences and further work through the internet, an initial 42-item list was retained. From this list a second list,

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Next, with a partner, 15 kits will be made and sent to 3 pilot sites familiar with modern wound care (two in Africa, one in Haiti). This pilot phase will allow the necessary adaptations that will lead to a final 10-month-long test phase. At the end of this process, through the lessons gained, the definitive kit will be constituted.

Collaboration with industry is still open and will be crucial in the realisation of the kit.

For any questions, please do not hesitate to contact the authors. n Hubert Vuagnat Hubert.Vuagnat@hcuge.ch,

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Eric Comte, Eric.comte@geneva.msf.org

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Kit items: Gauze and dressing

WAWLC was officially launched as a global partnership encouraged by the WHO in 2009. Read more about WAWLC activities at www.wawlc.org. WAWLC is an international partner organisation of EWMA.

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Non-woven gauze, sterile

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Non-woven gauze, non-sterile

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Paraffin gauze, sterile

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Transparent polyurethane film Bandaging

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Cohesive bandage

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Under cast padding, roll

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Crêpe bandage Tape

WALWC SESSION AT EWMA 2015 At the EWMA conference in London, a WAWLC guest session will be held with the title “Update on WAWLC Activities in Resource-limited Settings.” The session will feature an update on the kit development process.

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2-cm adhesive tape roll

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10-cm adhesive tape roll Cream and ointment

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Vaseline cream

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Silver sulphadiazine Hygiene and disinfectant

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Sterile saline

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Liquid soap

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Polyvidone iodine, 10%, solution

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Alcohol gel hand rub with dispenser

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Disposable gloves, non-sterile

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Scalpel blade, scalpel

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Scalpel blade, scalpel with handle

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Syringe 20 ml

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Disposable drapes

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Easy-to-use wound care protocols

REFERENCES

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Marker pen

1. Guidelines for medicine donations. WHO. Geneva. Third Edition 2011.

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Individual patient record

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Paper tape rules

Time: Wednesday 13 May 13.45-15.00 Place: Platinum 5 Chairs: David Keast, Hubert Vuagnat

Material

Writing and paper

2. Kit System Management. (Managing Access to Medicines and Health Technologies, Chapter 26). WHO. Geneva. 2012. http://apps.who.int/medicinedocs/documents/ s19603en/s19603en.pdf. [Accessed 24.06.2012] The authors would like to thank the rest of the working group: Kingsley Asiedu, Robyn Björk, David Keast, Jan Kristensen, John Macdonald, Terry Treadwell and, of course, all of the other individuals who contributed to this work.

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Sharp container

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Obituary 20 April 2015

Visit EWMA on our Social Media platforms Follow us and get the latest ­updates about EWMA activities:

www.facebook.com/ EWMA.Wound

www.linkedin.com/company/ european-wound-managementassociation

Twitter: @ewmatweet

GRAPHIC DESIGNER OF EWMA JOURNAL SINCE 2001, BIRGITTE CLEMATIDE It is with great sorrow that we have received the information about Birgitte Clematide’s death a few days ago.

Birgitte has been the most important person behind EWMA’s graphical design for the past 15 years.

She created the design for EWMA Stockholm 2000, the new EWMA logo in 2000 and the first EWMA Journal in 2001.

Since then, she has been instrumental in the graphic design for all EWMA Journals and conference programmes.

Her original expression helped define the characteristic and easily recognizable profile of EWMA and the EWMA conferences. Hers was a talent combined by the critical curiosity of the academic, the great imagination of the artist and the professionalism of the craftsman.

She will be missed by everyone involved in EWMA. On behalf of The European Wound Management Association (EWMA)

Instagram: @ewmapics

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EWMA NEWS Organisations

AWMA NEWS AWMA Australian Wound Management Association

Margo Asimus, AWMA President

It is with great pleasure that I have been offered this opportunity to introduce myself to the EWMA membership. In May 2014, I was appointed AWMA President. For over 20 years, I have enjoyed being involved in the specialty of wound management, first as a stomal therapist/wound specialist/infection control officer in the acute system that inspired a goal to become a nurse practitioner in the community setting consulting in high-risk, communitybased clinics from 2004. Since 2012, I have worked as Vice President for AWMA alongside our now immediate past president Bill McGuiness.

In the second half of 2014, the AWMA committee was closely aligned to the strategic direction and focused activity in identified key result areas (KRAs). Each area has executive leadership with the following defined objectives: 1. Profile 2. Growth 3. Governance 4. Education & Research 5. Nationalisation

Jane Andrews Deputy CEO, Wound Management Innovations CRC Australia

www.awma.com.au

The WMI CRC is a joint venture involving 20 participating industry, academic and end-user organisations with a shared vision of transforming wound outcomes. The WMI CRC has four operational areas, including research, development, clinical translation and education. The WMI CRC was established in 2010 with over $100 million dollars of cash and in-kind contributions from the Australian Government and WMI CRC participants.

The partnerships and relationships between AWMA and WMI CRC continue to grow stronger as our collaborations and synergies forge ahead, and we strive together to achieve great results in key areas.

2015–2016 will bring some significant changes to AWMA as we know it today. However, as we continue to increase membership, undertake political lobbying, collaborate with our international partners and conduct awareness campaigns, we must move away from a hard-working voluntary organisation to a business that functions efficiently and grows to meet the needs of Australians. I look forward to leading this challenge together with our motivated AWMA committee and partnership from the WMI CRC.

Establishing this framework has moved AWMA closer to a portfolio structure in preparation for Nationalisation when it occurs later this year.

In addition to the KRA activities, AWMA subcommittees have been very productive in planning projects that are scheduled for completion over the next 12 months: n Australian and New Zealand Clinical Practice Guidelines for the Prevention and Management of Venous Leg Ulcers revision n Wound Aseptic Technique position documents n Australian Wound Management Association Standards revision n Wound Awareness Campaign (August launch) The Wound Management Innovation CRC (WMI CRC) is working with AWMA on characterising the dimensions of Australia’s wound problems by establishing a National Wound Registry. Clinical registers are recognised as efficient tools to improve health outcomes and to reduce direct health costs. In addition, the WMI CRC and AWMA will be jointly launching a patient awareness campaign to ensure that people with wounds are directed to the most appropriate resources.

EWMA international Partner Organisation

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AAWC NEWS AAWC Association for the Advancement of Wound Care

Dear Colleagues and Friends at EWMA, The Association for the Advancement of Wound Care (AAWC) is pleased to update the readers of the EWMA Journal. The year 2015 commemorates the historical and successful evolution of AAWC as we celebrate its 20th Anniversary.

Much like EWMA, a diverse interprofessional membership and the patients we serve are our inspiration. It is diversity that keeps our organisations strong! Since my last report, AAWC has flourished both in sustaining membership and significantly increasing sponsorship support.

Vickie R. Driver President of AAWC

ABOUT AAWC As the leading interpro­ fessional organisation in the United States dedicated to advancing the care of ­people with and at risk for wounds, AAWC provides a whole year of valuable benefits! Be sure to join us for near daily updates and alerts on Facebook and LinkedIn. www.aawconline.org

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AAWC continues as the host society, along with WHS as co-host, for the multi-societal initiative in the US entitled “Wound-care Experts/FDA—Clinical Endpoints Project (WEF-CEP)”. Because “complete closure” is the only current endpoint that the US Food and Drug Administration (FDA) uses to determine drug and device therapy approvals, our teams are developing a new set of clinical endpoints to propose to the FDA—additional endpoints that are meaningful to our patients.

In the spirit of collaboration, we are working with the Wound Healing Society, as well as experts in Canada and Mexico, to evaluate the intricate process for combining multiple guidelines over the next few years. While each wound care association involved will continue to advance its own important mission for our field, AAWC’s vision is that one day there will be one set of resources supported by tens of thousands of multidisciplinary, collaborative, professional organisation members.

HELP SHA

PE OUR F

IELD!

Attend the AAWC’s 20th Anniv ersary Mem bership Me eting at the Sym posium on Advanced Wound Ca re (SAWC) San Anton io, US, April 30 May 3, 20 15

You also will not want to miss the AAWC 20th Anniversary Celebration on Friday from 8:30 PM – 10:30 PM. Special gifts will be provided, and there will be exciting announcements, including the presentation of the 2015 AAWC Distinguished Member Award! Enjoy door prizes, food, drinks, live DJ music, dancing and fun! We thank SAWC for sponsoring this delightful fiesta-style party!

I would be remiss not to mention our Association board members, volunteer committee chairs, members and staff who are monumental contributors to our success. Last but not least, we are proud to be represented by over 70 members from more than 30 countries. The AAWC thanks all of its multidisciplinary members and warmly invites all EWMA readers to join AAWC.

SAWC Spring in San Antonio, April 30-May 3 will be the most exciting US symposium in years. Not only are we celebrating the Association’s 20th Anniversary but also we are launching the inaugural AAWC Clinical Practice Track. We hope you will choose some or all of these sessions as you create your personalised SAWC schedule.

AAWC is hard at work shaping the field of wound care as an advocate for this profession and our patients. We are already working for you—why not make it official and join? Together, we can advance the practice of wound care.

If you will be attending SAWC Spring, please join us at our 20th Anniversary Membership Meeting: “Help Shape Our Field!” on Friday from 6 PM – 7:15 PM. This will be an interactive meeting where we will recount the great strides forward AAWC has made over the last 20 years. Join us to learn more about our current initiatives and exciting upcoming plans.

Dr. Vickie R. Driver President, AAWC

Sincerely,

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EWMA NEWS Organisations

RESPONSE TO THE CHALLENGES OF CHRONIC WOUND DISEASES: CTRSâ&#x20AC;&#x2122;S ACTION

Prof. Xiaobing Fu President of CTRS

CTRS is a new EWMA international Partner Organisation www.chinese-trs.com/en

EWMA international Partner Organisation

EWMA Journalâ&#x20AC;&#x201A;

Currently, in China, economic improvement has been accompanied by a great change in lifestyle, along with an increasing incidence of chronic diseases. In 1998, a multicentre epidemiological study on inpatients with chronic wounds indicated that the leading cause of chronic cutaneous wounds was trauma (67%), with a low frequency of diabetic foot ulcers (DFUs; <5%). Ten years later, the leading causes of chronic cutaneous wounds were DFUs (32.6%), trauma/burns (23.8%), iatrogenic factors (10.6%) and pressure ulcers (10.5%). This result is directly proportional to the high morbidity of diabetes in China. The prevalence of diabetes changed from 2.5% in 1994 to 5.5% in 2001 and reached 9.7% in 2008. Regarding the worldwide average morbidity of DFUs (15%), China has an estimated prevalence of at least 100 million adults with diabetes, for about 15 million patients with DFUs.

Another focus of CTRS is addressing the training issue. CTRS has developed a 3-year training programme in wound care in China that is sponsored by the World Diabetes Foundation and Coloplast Access to Healthcare foundation. The project focuses on training physicians and nurses in wound care for patients with diabetic mellitus and other chronic skin wounds. In the past 2 years, 1,618 health care professionals, including 915 physicians and 703 nurses, have been trained. Participants are from more than 200 hospitals in 21 provinces.

About 1,200 patients per month on average have benefited from this project. In total, 13 hospitals have become training bases to continue the education program. The aim of the program is to help Chinese medical professionals efficiently manage chronic wounds, thereby shortening the wound healing time, reducing the amputation rate and treatment costs, and improving the quality of life.

Chronic wounds such as DFUs, pressure ulcers, and leg ulcers take a long time to heal and can be accompanied by high disability. Such ulcers seriously affect the quality of life of patients and have a heavy burden on social security. Just several years ago, China had only a few wound care units or wards in hospitals where health care professionals can provide systematic treatment with advanced knowledge and new technology on wound care. As one of the examples, most Chinese patients with DFUs see physicians in different departments, such as endocrinology, orthopaedic, vascular surgery, general surgery, trauma surgery, burns and plastic surgery, dermatology, and emergency departments.

Thus, the therapeutic results can vary greatly because of a lack of knowledge and limited technology in different departments.

Another training program specifically for GP and G nurses from Shanghai Community Health Care Centres was completed in 2013. More than 200 participants have joined the programmes with 4 training courses.

To cope with the challenge, the Chinese Tissue Repair Society (CTRS) has been making great efforts to promote the development of wound healing in China and is endowed with multidisciplines and specialisations. The vision is to improve wound management, and the strategy is to offer concerted care while continuing to pursue research excellence into the understanding of disease pathology and exploring the role of technologies.

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The training project led by CTRS covered the eastern half of the country.

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ELCOS Sociedade de Feridas

Kátia Furtado ELCOS President

Tânia Santos ELCOS Assembly

ELCOS is a new EWMA Cooperating Organisation EWMA Cooperating Organisation

www.sociedadeferidas.pt

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ELCOS Portuguese Wound Society - an innovative approach ELCOS is a scientific society that assembles professionals from different areas (health, education and research) who have a common interest in promoting the discussion, training and research in tissue viability and wound care. Currently, there are 720 members comprising nurses, physicians, physiotherapists, psychologists, nutritionists, and pharmacists.

The founders of ELCOS include some co-founders and representatives of counterpart organisations at the national and international levels who intended to embody a project on the national scene: an organisation with the ultimate aim of promoting public health.

This initial group, with multidisciplinary training acquired in Portugal and abroad (in the fields of nursing, chronic wounds, nutrition, psychology, and health facilities management), all with specialised training in community health, launched the project that was anchored along political lines and was clearly defined in its mission, vision and values.

Ambitious but conscious, with policy outlined in its limits, the founding group invited the ELCOS Board and its departments and regional councils comprised of different professionals. All have in common the interest to promote and/or support educational, technical, scientific, ethical and research initiatives in the prevention and treatment of wounds, thus covering clinical practice, teaching and scientific research. Therefore, the human capital of ELCOS consists of professionals at various levels in the scientific community: physicians (specialists in general surgery, vascular, plastic, endocrinology and dermatology), nurses (specialists in various areas), pharmacists, engineers specialising in media applied to the areas of telemedicine and university teachers.

The board members and regional councils consist of a cast with scientific knowledge (with bachelors, masters, and doctorates), ensuring sustained activity in terms of research training, with representation at the level of the EPUAP, EWMA and WHO. To fulfil its goal, the ELCOS-Portuguese Healing Society and the Study and Research Wound Centre are organised geographically into regional councils, aiming to address regional nosology in terms of chronic wounds through the involvement of interested professionals in each region, in partnership with health and education institutions at a local level.

We intend to identify in each region the existing nosology in terms of chronic wounds, the incidence

and prevalence, human resources, and knowledge to develop a regional action plan that allows sustained work developed in partnership with institutions to respond in a directed way to the specific problems of each region. In this task to eradicate the disease within the context of poverty in which so many times it appears we follow the words of the General Director of WHO (1983): “Everyone is on and has the power to change things: citizens of the villages and cities, families and communities and all sorts of political and social groups, such as education and research institutions, non-governmental organizations and professional associations. But also health experts and those responsible for the community, such as civil and religious leaders, teachers, judges, workers of social security.”

Without the deep involvement of the entire population, health for all will always be a mirage.

Every year, ELCOS holds an annual Iberian Forum of Ulcers and Wounds in a different city and, this year (2015), the VI Iberian Forum will occur in Lisbon. Furthermore, and following the mission of covering clinical practice, teaching and scientific research in partnership with health and education institutions, we will conduct Post Graduate Courses in Tissue Viability in partnership with universities throughout Portugal and Basic and Advanced Courses in Wound Management in partnership with health institutions.

In 2014, following the agenda led by the International Diabetes Federation and joining the global diabetes community to produce a powerful voice for diabetes awareness and advocacy, we organised the 1st Iberian Symposium in Diabetes, and it was a success with the presence of national and international economists, politicians and health professionals.

By joining ELCOS, members receive a discount at our annual Forum and in so many other activities that we develop. For instance, we have published a Wound Dressing book in 2012, and we are completing another book on debridement that will be launched in March 2015.

All publications are free for ELCOS members.

For more information, please visit us at www.sociedadeferidas.pt EWMA Journal

2015 vol 15 no 1

EWMA 2016 BREMEN · DE 11-13 MAY 2016

THE EWMA UNIVERSITY CONFERENCE MODEL (UCM) IN BREMEN

The EWMA UCM programme offers students of wound management from institutes of higher education across Europe the opportunity to take part of their academic studies whilst participating in the EWMA Conference.

The opportunity of participating in the EWMA UCM is available to all teaching institutions with wound ­management courses for health professionals.

The UCM programme at the EWMA 2016 Conference in ­Bremen will offer networking o ­ pportunities between the students from various UCM groups, UCM Lectures as well as assignments and workshops arranged specifically for the UCM students.

EWMA strongly encourages teaching institutions and students from all countries to benefit from the possibilities of international networking and access to lectures by many of the most experienced wound management experts in the world.

PARTICIPATING INSTITUTIONS:

Donau Universität Krems Austria

Haute École de Santé Geneva, Switzerland

HUB Brussels Belgium

Lithuanian University of Health Sciences Lithuania

University of Hertfordshire United Kingdom

Universidade Católica Portuguesa Porto, Portugal

Yours sincerely

Dubravko Huljev Chair of the Education Committee

For further information about the EWMA UCM, please visit the Education section of the EWMA website www.ewma.org or contact the EWMA Secretariat at ewma@ewma.org

Make a difference in clinical practice Become a Member of EWMA

Benefits of your EWMA Membership: n You make a difference in clinical practice within wound management in Europe n Right to vote and stand for EWMA Council n EWMA Journal sent directly to you two times a year n EWMA news and statements sent directly to you n A discount on your registration fee for EWMA Conferences n Right to apply for EWMA travel grants n Yearly membership fee € 25 n Yearly membership fee for members of cooperating organisations € 10

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Organisations

SLOVAK WOUND HEALING SOCIETY SLOVAK WOUND HEALING SOCIETY

Associate Professor Jan Koller, M.D., Ph.D. SSPLR President

SSPLR is a new EWMA Cooperating Organisation

EWMA Cooperating Organisation

INTRODUCTION The Slovak Wound Healing Society (SSPLR ) was founded in 2012 as a professional association of health care professionals dealing with the management and care of both acute and chronic wounds of different origin. SSPLR, following its establishment, applied and was accepted as an organisational unit of the Slovak Medical Association (SkMA).

MISSION AND OBJECTIVES OF SSPLR n SSPLR is an association of health care profes sionals who participate in the management and care of acute and chronic wounds of different aetiology n SSPLR aims to comprehensively solve both health and social care problems in the area of wound management n SSPLR aims to transfer the latest scientific, professional, medical, diagnostic and therapeu tic knowledge into practice in continuous medi cal education and practical training activities n SSPLR shall assert a decisive role in the prepara tion of professional standards for wound care at the hospital, outpatient and home care levels n SSPLR shall initiate, submit, enforce and publish professional opinions on the following: - issues pertaining to expertise and scientifi cally based knowledge of wound management - ethical issues for physicians and other health care professionals - issues related to existing and preparing regulatory standards and professional opinions in health care - nominations of experts as members of various committees n SSPLR shall nominate members to represent the society in international professional wound care associations, particularly in the EWMA Coope rating Organisations.

INFORMATION CONCERNING PAST OR UPCOMING CONFERENCES/MEETINGS Since its establishment, SSPLR has participated actively in several wound healing sessions at national scientific meetings of other SkMA professional associations such as the Annual Conference of the Slovak Angiology Society in 2013 and the Slovak Surgical Society in 2013 and 2014. SSPLR provided

scientific guarantee and lecturers for two wound healing scientific workshops in the year 2013 and three in 2014. At least two more such workshops are scheduled to occur in February and April 2015.

Members of SSPLR actively participated presenting lectures and posters at the EWMA conferences in 2013 and 2014. Active participation is also expected at the 2015 EWMA annual conference in London.

DESCRIPTION OF RESEARCH PROJECTS IN WOUND HEALING OR WOUND MANAGEMENT SSPLR is planning to initiate educational programmes in wound healing management at the national level in Slovakia in the very near future.

EWMA position documents are being translated into the Slovak language. A continuous education programme also using EWMA position documents for all levels of wound healing professionals is in preparation. The next step is the preparation of national guidelines for wound management in Slovakia.

Presentation of the opportunities and challenges within the organisation of wound care in Slovakia As in other countries, many problems exist in the management of chronic wounds such as leg ulcers, diabetic ulcers and pressure sores. Regarding the novel treatment methods and use of advanced medical devices for chronic wound treatment, some are fully reimbursed, while others are partially reimbursed by health care insurance companies.

The most important challenges of SSPLR in the near future include the initiation of educational activities in wound management along with setting up wound healing facilities at regional levels. The continuing medical education programmes will be organised at a level for physicians, as well as at a level for nurses, on regional principles to enable easier participation of all health care personnel engaged in wound management in the activities.

All of the continuing medical education seminars and practical courses will be accredited and organised, according to national CME regulations, in cooperation with the Slovak Accreditation Council for Continuing Medical Education. We are also expecting an even closer cooperation with EWMA and the EWMA Cooperating Organisations in this field.

www.ssplr.sk/en

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2015 vol 15 no 1

HELLENIC SOCIETY OF WOUND HEALING THE HELLENIC SOCIETY OF WOUND HEALING

Georgia Koulermou, President of HSWH, MD, PhD, Director of the Department of Plastic Surgery and Burns, Nicosia General Hospital, Hon. Professor of Plastic Surgery

The Hellenic Society of Wound Healing and Chronic Ulcers (HSWH) was founded in 2003 as a scientific non-profit association. The Society is based in Athens but also has members from other Hellenic cities all over Greece and from Cyprus. The main aims and objectives of the Society are: n To cooperate closely with the relevant national and European authorities to improve the services to patients with chronic and acute tissue deficits n To reduce the psychosocial effects created by these deficits n To promote prevention by giving best training on health professionals. n The reduction of treatment costs n The improvement of quality of life of these patients n To promote continuing education, both health professionals and the public concerned by organising educational events n To contribute in establishing cooperation between national professionals and international organisations n To promote research in this area, having the ability for sponsored research programs n To provide advisory and educational services to patients and their relatives, agencies and health care professionals n To improve wound care standards, according to the international guidelines, for patients HSWH works to achieve these objectives through encouragement and guidance of research, particularly among young scientists, as well as through the systematisation of knowledge concerning chronic and acute trauma in Greece, and the supervision and execution of postgraduate and continuing education programs.

HSWH is a new EWMA Cooperating Organisation EWMA Cooperating Organisation

ACTIVITIES Between 2003 and 2013, HSWH has organised the National Would Healing Conference, which occurs bi-annually with 500–1000 participants.

During the National Congress, the “Ioannovich Award” is given to the best scientific presentation.

Furthermore, HSWH offers four to five scholarships for young scientists to follow a programme at wound healing centres abroad.

HSWH is often invited to national and international scientific conferences; among these are the Annual National Conference of Hellenic Association of Nurses (ESNE) and the Annual National Conference of Hellenic Doctors (PIS).

Furthermore, HSWH have been invited to organise several workshops at hospitals of the public, military and private sectors, as well as to co-organise several educational programmes at the Plastic Surgery department and Burn Center of Nicosia General Hospital in Cyprus focusing on the prevention of pressure ulcers.

HSWH has co-organised meetings with the Mediterranean Council for Burns and Fire Disasters (MCB) and European Tissue Repair Society (ETRS), as well as supported seminars for European Academy of Wound Technology (EAWT).

Moreover, HSWH performed a Practical Training Program in collaboration with the World Union of Wound Healing Societies (WUWHS) and organised five workshops of Advanced Burn Life Support (ABLS).

In 2012, HSWH co-organised an EAWT approved Summer School that also focused on the prevention of pressure ulcers.

RESEARCH EFFORTS In January 2007, HSWH organised the first national pressure ulcer prevalence study in which approximately 30 hospitals all over Greece participated, and the prevalence was found to be 8,08%.

The future plans and objectives are important for the board. HSWH will continue the engagement in new and existing research activities and collaborations with Greek and International Scientific Societies. In addition, the elaboration of guidelines for health care professionals is planned for the near future.

HSWH has established an excellent level of collaboration with the industry, which is considered an important partner in the dissemination of knowledge concerning wound healing and wound management. Any advice, comments or criticisms offered by the industry are reviewed by the academic and clinical partners in the organisation.

The area of wound care in Greece leaves much to be desired because reforms and economic restraints result in decreasing budgets in all sectors of the Greek healthcare system, including the wound healing sector. Also, the lack of specialised centres is considered a challenge for the advancement of wound healing in Greece.

Finally, even more improvement could be made within education and research in wound healing in our country—for example, by creating a masters degree in the area of Advanced Wound Management.

www.hswh.gr

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EWMA

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Organisations

Conference Calendar Conferences 2015

Theme

Annual Meeting of Swedish Wound Care Nurses Association (SSiS) Spring Symposium on Advanced Wound Care and Wound Healing Society (SAWC)

Month

Days

City

Country

Medical techniques in wound April diagnostics and wound treatment.

20-21

Stockholm

Sweden

Interdisciplinary Diabetic Foot, Amputation Prevention, PAD and Wound Care

29 -3

‘San Antonio, TX USA

April-May

Deutscher Pflegekongress / Deutscher Wundkongres May 6-8

Bremen

Germany

25th Conference of the European Wound Management Association (EWMA)

London

United Kingdom

7th International Symposium on the Diabetic Foot (ISDF) May 20-23

7th Annual Conference 2015 of the Wound Care May 21-23 New Zealand Wound Care Society (NZWCS) – A Matter of Balance

16th European Federation of National Infection May 27-29 Associations of Orthopaedics and Traumatology (EFORT) Congress

The Hague

The Netherlands

Blenheim

New Zealand

Prague

Czech Republic

Annual congress of the Swiss Association for Woundcare (SAfW Romande)

May

28

Morges

Switzerland

27th National Congress of the Spanish Association of Vascular Nursing and Wounds (AEEVH)

June

4-5

Castellon

Spain

Rande 2015 Wound Healing & Tissue Repair June 11-12

18. Jahreskongress (DGfW) June 18-20

Trinec

Czech Republic

Ludwigshafen

Germany

34th Annual Congress of European Bone and Joint Infection Society (EBJIS) September 10-12

18th Annual European Pressure Ulcer Advisory Putting the Pressure September 16-18 Panel Meeting (EPUAP) in the Heart of Europe

Estoril, Lisboa

Portugal

Ghent

Belgium

16th European Burns Association Congress (EBA)

September

16-19

Hannover

Germany

Eliminating Heel Pressure Ulcers

September

24

London

UK

“WOUND CARE – SHAPING THE FUTURE A PATIENT, PROFESSIONAL, PROVIDER AND PAYER PERSPECTIVE”

May

13-15

The 15th Annual Leg Club Conference Handle with Care. Head to Toe September 23-24

Aspects of Wound Healing

DEBRA International Annual Congress September 25-26

Worcester Rugby Club UK London

UK

Society of Advanced Wound Care Fall Symposium (SAWC)

The Pisa International Diabetic Management of the Foot Courses 2015 Diabetic Foot

September

26-28

Las Vegas

United States

September- October

30-3

Pisa

Italy

17th Annual Meeting of the Austrian Wound Association (AWA) October 2-3

13th Annual Congress of the Italian Association October 7-10 for the study of Cutanecus Ulcers (AIUC)

St. Pölten

Austria

Bari, Fiera

Italy

24th Conf. of the European Academy of Dermatology and Venereology (EADV) October 7-11

National Multidisciplinary Congress (NOVW) Trilogy about Wounds October 13

Copenhagen

Denmark

Ede

Netherlands

7th Joint Meeting of ETRS & WHS

Copenhagen

Denmark

‘From Bed to Bench’

October

21-23

21st Annual Conference of Canadian Association of Wound Care (CAWC)

Oct-Nov

29-1

Toronto

Canada

VIII Ibero-Latin American Congress about Ulcers and Wounds (SILAUHE)

November

11-13

Mérida

Mexico

Together - Smarter in Woundcare November

24-25

Utrecht

The Netherlands

15th Congress of the Wound Care Society (WCS)

11th Annual Conference of Ukraine Wound Treatment Organisation (UWTO)

November

26-28

Kiev

Ukraine

Annual Meeting of Danish Wound Healing Society (DSFS)

November

27-28

Billund

Denmark

For web addresses please visit www.ewma.org EWMA Journal

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Cooperating Organisations

CSLR

Czech Wound Management Society www.cslr.cz

AEEVH

Spanish Association of Vascular Nursing and Wounds www.aeevh.es

CWA

Croatian Wound Association www.huzr.hr

AFIScep.be

French Nurses’ Association in Stoma Therapy, Wound Healing and Wounds www.afiscep.be

DGfW

German Wound Healing Society www.dgfw.de

AISLeC

DSFS

Italian Nurses’ Cutaneous Wounds A ­ ssociation www.aislec.it

D A N I S H WO U N D HEALING SOCIE T Y

Danish Wound Healing Society www.saar.dk

AIUC

ELCOS

Italian Association for the study of Cutaneous Ulcers www.aiuc.it

Portuguese Wound Society www.sociedadeferidas.pt

AMP Romania

FWCS

Wound Management Association Romania www.ampromania.ro

Finnish Wound Care Society www.shhy.fi

APTFeridas

GAIF

AWTVNF

GNEAUPP

All Wales Tissue Viability Nurse Forum www.welshwoundnetwork.org

National Advisory Group for the Study of P ­ ressure Ulcers and Chronic Wounds www.gneaupp.org

AWA

HSWH

Associated Group of Research in Wounds www.gaif.net

Portuguese Association for the Treatment of Wounds www.aptferidas.com

Hellenic Society of Wound Healing and Chronic Ulcers www.hswh.gr

Austrian Wound Association www.a-w-a.at

ICW

BEFEWO

Chronic Wounds Initiative www.ic-wunden.de

Belgian Federation of Woundcare www.befewo.org

LBAA

Latvian Wound Treating O ­ rganisation

BWA

Bulgarian Wound Association www.woundbulgaria.org

LUF

The Leg Ulcer Forum www.legulcerforum.org

CNC

Clinical Nursing Consulting – Wondzorg www.wondzorg.be

LWMA

Lithuanian Wound Management Association www.lzga.lt

SOBENFeE

Brazilian Wound M ­ anagement ­Association www.sobenfee.org.br

International Partner Organisations AAWC

Association for the Advancement of Wound Care www.aawconline.org

AWMA

Australian Wound Management Association www.awma.com.au

CAWC

Canadian Association of Wound Care www.cawc.net

Debra International

IWII

Int. Wound Infection Institute www.woundinfection-institute.com

ILF

KWMS

Korean Wound Management Society www.woundcare.or.kr/eng

NZWCS

EFORT

SILAUHE

CTRS

(Chinese Tissue Repair Society) www.chinese-trs.com/en

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World Alliance for Wound and Lymphedema Care www.wawlc.org

International Lymphoedema ­Framework www.lympho.org

Dystrophic Epidermolysis Bullosa Research Association www.debra.org.uk European Federation of National Associations of ­Orthopaedics and Traumatology www.efort.org

WAWLC

New Zealand Wound Care Society www.nzwcs.org.nz Iberolatinoamerican Society of Ulcers and Wounds www.silauhe.org

SOBENFeE

Brazilian Wound M ­ anagement ­Association www.sobenfee.org.br

Associated Organisations Leg Club

Lindsay Leg Club Foundation www.legclub.org

LSN

The Lymphoedema Support Network www.lymphoedema.org/lsn

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2015 vol 15 no 1

Organisations

MASC

SSOOR

MSKT

SSPLR

MWMA

STW Belarus

Maltese Association of Skin and Wound Care www.mwcf.madv.org.mt/

Hungarian Wound Care Society www.euuzlet.hu/mskt/

Macedonian Wound Management Association

NATVNS

National Association of Tissue Viability Nurses, S ­ cotland

NIFS

Norwegian Wound Healing Association www.nifs-saar.no

NOVW

Dutch Organisation of Wound Care Nurses www.novw.org

PWMA

Polish Wound Management Association www.ptlr.org.pl

SAfW

Swiss Association for Wound Care (German section) www.safw.ch

SAfW

Swiss Association for Wound Care (French section) www.safw-romande.ch

SAWMA

Serbian Advanced Wound Management Association www.lecenjerana.com

SEBINKO

Hungarian Association for the Improvement in Care of Chronic Wounds and Incontinentia www.sebinko.hu

SEHER

The Spanish Society of Wounds www.sociedadespanolaheridas.es

SFFPC

The French and Francophone Society f Wounds and Wound Healing www.sffpc.org

SSiS

Swedish Wound Care Nurses Association www.sarsjukskoterskor.se

Slovak Wound Care Association www.ssoor.sk

The Slovak Wound Healing Society www.ssplr.sk/en

Society for the Treatment of Wounds (Gomel, Belarus) www.burnplast.gomel.by

SUMS

Icelandic Wound Healing S ­ ociety www.sums.is

SWHS

Serbian Wound Healing Society www.lecenjerana.com

SWHS

Swedish Wound Healing Society www.sarlakning.se

TVS

Tissue Viability Society www.tvs.org.uk

URuBiH

Association for Wound Management of Bosnia and Herzegovina www.urubih.ba

UWTO

Ukrainian Wound Treatment Organisation www.uwto.org.ua

V&VN

Decubitus and Wound Consultants, N ­ etherlands www.venvn.nl

WMAI

Wound Management A ­ ssociation of Ireland www.wmai.ie

WMAK

Wound Management Association of Kosova

WMAS

Wound Management Association Slovenia www.dors.si

WMAT

Wound Management A ­ ssociation Turkey www.yaradernegi.net

Other Collaborators DFSG

Diabetic Foot Study Group www.dfsg.org

EADV

European Academy of Dermatology and Venereology www.eadv.org

EPUAP

European Pressure Ulcer Advisory Panel www.epuap.org

ETRS

European Tissue Repair Society www.etrs.org

Eucomed

Eucomed Advanced Wound Care Sector Group www.eucomed.org

EWMA Journal

2015 vol 15 no 1

Home Care Europe

ICC

International Compression Club www.icc-compressionclub.com

MSF

Médecins Sans Frontières www.msf.org

WUWHS

The World Union of Wound Healing Societies www.wuwhs.org

For more information about EWMA’s Cooperating Organisations please visit www.ewma.org 111

6 Editorial

Science, Practice and Education 8 Efficacy of magnetic resonance imaging in deciding the appropriate surgical margin in diabetic foot osteomyelitis. Fujii M, Armstrong DG, Terashi H 15 Ex vivo platelet activation with extended duration pulse electric fields for autologous platelet gel applications - A new, potential clinical standard for platelet activation and perspectives for a more widespread adoption and improved wound healing with platelet gels. Neculaes VB, Torres A, Morton C, Larriera A, Klopman S, Conway K, Garner AL 21 Pressure ulcer reduction: the role of unregistered healthcare support workers in validation and prevention. Ellis MB, Price J 27 Measuring change in limb volume to evaluate lymphoedema treatment outcome. Williams AF, Whitaker J

Scientific Communication 35

42

47

54 61

65 71

Emerging targeted technology to address unmet clinical needs - Implementing a development and adoption strategy. Vowden P Great opportunities ahead! Don’t miss the boat! Where tech meets health care. Reig J, Valverde JA, Reig M A patient-led approach to product innovation in patient education and wound management. McNichol E, McKay A, Milligan C, Bennett K, Hulme R, Joy H European perspectives on biomaterials for health. Donnelly F An eLearning modular approach to pressure Ulcer prevention and management: the views of nursing staff. Cameron R, Rodgers A, Welsh L, McGown K Major and minor amputation rates: What do they tell us?. Kröger K Wound risk and prevention in obesity: The role of nutrition Ballesteros-Pomar MD

Cochrane Reviews 77 Abstracts of recent cochrane reviews. Bell-Syer S

EWMA 84 EWMA Journal previous issues and other journals 86 EWMA 2015 Conference in London, UK, José Verdú Soriano 88 Promoting antimicrobial stewardship in wound care 91 eHealth in wound care - overview and key issues to consider before implementation. Moore Z 93 EWMA news 97 Report from the 6th Pisa International Diabetic Foot Course 2014 Piaggesi A 98 The woundcare kit - a key tool for wound Care in a humanitarian Environment. Vuagnat H, Comte E 100 Obituary notice

Organisations 101 AWMA news. Asimus M, Andrews J 102 AAWC news. Driver VR 103 Response to the challenges of chronic wound diseases: CTRS’s action 104 ELCOS - Portuguese Wound Society - an innovative approach Furtado K, Santos T 106 Slovak Wound Healing Society (SSPLR). Koller J 108 Hellenic Society of Wound Healing (HSWH). Koulermou G 109 Conference calendar 110 Cooperating Organisations