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Volume 17 18 2 Number 1 October 2017 April 2016 Published Published by by European Wound Wound Management Management Association


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5 Editorial. Sebastian Probst, Editor of EWMA Journal

Science, Practice and Education 7 Evaluation of a newly designed moisture management product for use in women giving birth at the Canberra Centenary Hospital for Women and Children. Broom M, Dunk A M, Sheridan D, McLeod M 15 Advancing professional health care practice and the issue of accountability. Cornock M 21 The changing US healthcare climate: What does it mean for wound care? Nusgart M 27 Core outcome set for Venous leg ulceration “CoreVen” Hallas S, Nelson A, O’Meara S, Gethin G 33 Negative Pressure Wound Therapy: Future Perspectives Apelqvist, J, Willy C, Fagerdahl A, Fraccalvieri M, Malmsjö M, Piaggesi A, Probst A, Wowden P

Cochrane Reviews 39 Abstracts of Recent Cochrane Reviews Rizzello G

EWMA 50 EWMA’s focus areas for the years 2017 - 2019 Bale S 52 EWMA 2018 Conference in Krakow, Poland 56 EWMA 2017 Conference in Amsterdam, the Netherlands 60 New EWMA Council Members 61 Appreciations: Leaving Council Members 64 EWMA Journal Previous Issues and Other Journals 66 EWMA Publications 69 Activities of the Cooperating Organisations during the EWMA 2017 Conference in Amsterdam Seppänen S 72 Launch of the Alliance for Research and Innovation in Wounds Gethin G, Coyne P, McIntosh C 74 Joint EPUAP & EWMA Pressure Ulcer (PU) Prevention & Patient Safety Advocay Project Moore Z, Soriano J V, Pokorna A, Schoonhoven L, Vuagnat H 76 Participation in the European Joint Action on Antimicrobial Resistance and Healthcare-associated Infections 78 New corporate sponsors 81 EWMA News

Organisations 82 Recognintion of wound care centres in Switzerland Wüthrich J, Kohler E, Mayer D, Von Siebenthal D, Signer M 86 Polish Wound Management Association. Sopata M 87 The International Federation of Podiatrists. Garoufalis M G 88 Association for the Advancement of Wound Care. Bohn G 90 Alliance of Wound Care Stakeholders. Nusgart M 91 Wounds Australia. Buck A 92 European Tissue Repair Society. Ågren M S 94 Corporate Sponsors 96 Conference Calendar 98 Cooperating Organisations, International Partners and Other Collaborators


The EWMA Journal ISSN number: 1609-2759 Volume 18, No 2, November, 2017 The Journal of the European Wound Management Association Published twice a year

EWMA Council Sue Bale

Severin Läuchli


Immediate Past President

Editorial Board Sebastian Probst, Switzerland, Editor Sue Bale, UK Vickie R. Driver, USA Georgina Gethin, Ireland Salla Seppänen, Finland Andrea Pocorna, Czech Republic EWMA web site www.ewma.org

Jan Stryja Treasurer

Selcuk Baktiroglu

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

Gregory Bohn

Georgina Gethin Honorray Secretary

Barbara den Boogert-Ruimschotel

Alberto Piaggesi Scientific Recorder

Magdalena Annersten Gershater

Edward Jude

Christian Münter

Julie Jordan O’Brien

Massimo Rivolo

Sara Rowan

Kylie SandyHodgetts

Layout: Nils Hartmann, Open design/advertising

Samantha Holloway

Sebastian Probst

Kirsi Isoherranen

EWMA Journal Editor

Pedro PancorboHidalgo

Luc Teot

Evelien Touriany

Printed by: Kailow Graphic, Denmark Copies printed: 5.000 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 April 2018. Prospective material for publication must be with the EWMA Secretariat as soon as possible and no later than January 15th 2017. 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.

COOPERATING ORGANISATIONS’ BOARD Esther Armans Moreno, AEEVH Christian Thyse, AFISCeP.be Valentina Vanzi, 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 Susan Bermark, DSFS Heli Kallio, FWCS Rosa Nascimento, GAIF J. Javier Soldevilla, GNEAUPP

Georgios Vasilopoulos, HSWH Björn Jäger, 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 Tânia Santos, ELCOS 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 Saša Milievic, SWHS Serbia Magnus Löndahl, SWHS Sweden Tina Chambers, TVS Jasmina Begi´c-Rahi´c, URuBiH Natalia Vasylenko, UWTO Ellie Lenselink, V&VN Peter Quataert, WCS 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 David Tequh, Netherlands Sylvie Meaume, France

Zena Moore, Ireland Christian Münter, Germany Andrea Nelson, UK Pedro L. Pancorbo-Hidalgo, Spain Hugo Partsch, Austria Elaine Pina, Portugal Patricia Price, UK 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

EWMA Journal editorial

It is a pleasure to present to you the October edition of the EWMA Journal under the headline of our next conference: “New Frontiers in Wound Management” Dear readers


his edition of the EWMA Journal is dedicated to our upcoming conference in 2018 which will be held in the historical city of Krakow, Poland. This conference is being organised together with the Polish Wound Management Association and under the theme ”New Frontiers in Wound Management”. The focus will be on the importance of improved and continued education for nurses, physicians, physical therapists and other healthcare professionals engaged in wound management. There is a need for a mix of wound care and wound management skills and knowledge among these professionals in order to improve the quality of wound care - a prerequisite for achieving best practices in wound management. Providing and improving education in wound management is thus an important pillar in the work of EWMA, which aims to improve and develop wound management in Europe. Examples of current educational development activities in which EWMA is involved: 1) The elaboration of a series of European curricula for the post-registration qualification of nurses. With this project EWMA aims to provide a more standardized content baseline for the existing and future educational programmes targeting levels 5 to 7 of the European Qualifications Framework (EQF). 2) The elaboration of a curriculum for physicians with the aim of ensuring a sufficient level of expertise for physicians engaged in wound management. The objective is to provide efficient and safe treatment for wound care patients and their families. This curriculum was approved by the European Union of Medical Specialists (UEMS) in 2015. 3) The EWMA UCM (University Conference Model) programme which offers students from institutes of higher education across Europe the opportunity to take a part

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of their academic studies in wound management whilst participating in the EWMA Conference. In this issue, you will find some information about our upcoming conference, in addition to four scientific papers. One paper from Australia illustrates an innovative redesign and tailoring of moisture products to meet clinical and women’s needs within a maternity environment through collaboration between industry and clinicians. Another paper outlines how health care practitioners can advance their practice. The third paper is from our colleagues of the United States and highlights the impact of the changing health care climate on wound care. The final paper presents a meeting report of the “Core Outcome Set for Venous Leg Ulceration (CoreVen) project”. This report describes the project’s introduction, rationale, purpose, and progress to date as well as to gain feedback on the proposed methodology. In this issue you will also find a chapter of the EWMA Negative PressureWound Therapy document (“Future Perspectives”). Finally, you will find an article by one of the EWMA Cooperating Organisations, the Swiss Wound Care Association (German section) focusing on the recognition of wound care centres, in addition to news from other collaborating partner organisations of EWMA.

I hope you all enjoy this issue.

Sebastian Probst, Editor and Council Member Professor in Wound Care, School of Health Sciences, University of Applied Sciences and Arts Western Switzerland Geneva, Switzerland


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Science, Practice and Education

Evaluation of a newly designed moisture management product for use in women giving birth at the Canberra Centenary Hospital for Women and Children ABSTRACT Introduction Although the incidence is rare (<1%), patients receiving care in hospital maternity wards are at risk of developing pressure injuries. These injuries create a significant economic burden worldwide. Reported risk factors for pressure injuries include epidural analgesia, immobility during labour, and increased temperature and excessive moisture, especially during birthing. Traditionally used moisture management devices often damage skin integrity, further heightening the risk for pressure injury. Here we describe an innovative moisture management product designed to better meet womenâ&#x20AC;&#x2122;s needs during pregnancy and birth.

Margaret Broom1

Ann Marie Dunk2

absorbent sheet or sanitary pads alone. Additionally, most patients reported that they were comfortable lying on the sheet and that using the sheet enabled them to worry less about embarrassing body fluid stains on their sheets or clothing. Similarly, the majority of midwives reported that the disposable absorbent sheet appeared to be comfortable and not restrictive. It also effectively managed moisture.

Discussion This study demonstrates the efficacy of the new disposable absorbent sheet for moisture management in patients treated in hospital maternity wards.

Clinical Significance Methods Clinicians worked together with the product manufacturer to develop an improved disposable absorbent sheet for moisture control before, during, and after birth. Pregnant women (n=79) used either the disposable sheet or sanitary pads alone, or the disposable sheet in conjunction with sanitary pads for moisture control; in-patients and their midwives (n=93) then completed surveys to evaluate the effectiveness of the various moisture control measures. Because multiple personnel caring for a single patient over the course of several shift changes, more surveys were completed by midwives than by patients. Four factors were considered during product evaluation: comfort, moisture management, mobility, and absorbency.

Results Both midwives and patients rated the comfort level of the new disposable absorbent sheet with sanitary pads significantly higher than that of the disposable EWMA Journalâ&#x20AC;&#x201A;

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Dawn Sheridan3

Redesigning the disposable absorbent sheet for maternal moisture management in collaboration with clinical experts has heightened awareness of the importance of efficient and safe moisture management while facilitating a Wellness Model of Care within the maternity setting.

Keywords Pressure injuries, microclimate, maternity, birthing, midwifery, skin integrity, moisture management.

INTRODUCTION Despite the advancements in health care throughout the past century1, pressure injuries remain a challenge for health care providers. In Australia, the annual economic burden associated with pressure injuries is estimated at US $1.65 billion, and many other countries world-wide experience a similar economic burden2. Pressure injuries also indirectly impact hospital operations by delaying î&#x201A;Š

Margaret McLeod4 1 Canberra

Centenary Hospital for Women & Children, NICU Australian Catholic University, Canberra

2 University of Canberra Clinical Nurse Consultant, Tissue Viability Unit Canberra Hospital and Health Services, ACT Health. 3 Canberra

Centenary Hospital for Women & Children, Maternity University of Canberra

4 Canberra

Centenary Hospital for Women & Children Charles Sturt University

Correspondence: margaret.broom@act.gov.au Conflicts of interest: None


discharge and further adding to the health facilities budget. The burden to the patient is also not negligible, as pressure injuries negatively impact patient quality of life, with many feeling as though they are hostage to the injury3. Pressure injuries also increase caregiver workload3. Pressure and shear forces are key factors in the development of pressure injuries; however, there are many other risk factors. Several of these factors may be short lived; however, because they contribute to skin or tissue damage, which in turn contribute to the development of pressure injuries, they inherently place patients at higher risk. Importantly, increasing evidence suggests that the microclimate between the skin and the supporting surface plays a role in pressure injury development, especially stage 1 and stage 2 pressure injuries4. Moisture Associated Skin Damage, an overarching term to describe skin damage caused by different types of moisture sources also contributes to development of pressure injury5. Although pressure injuries do not appear specific to age or medical condition, pregnant women experiencing longterm care in maternity wards are an important group that may be at higher risk for pressure injury due to the “perfect storm” mixture of risk factors they experience: immobility, poor microclimate management, temperature, and increased moisture at the skin surface. Pressure injuries also occur during labour and birthing, especially because increased usage of epidural analgesia and caesarean sections over the past 30 years have led to increases in the amount of time women may lay immobile during the labour and birthing process6,7,8,9. Additionally, women may also experience incontinence, amniotic fluid leakage, ruptured membranes, antepartum haemorrhage, and increased loading on the buttocks during labour, as well as postpartum haemorrhage and infection10, all of which place the skin at further risk of injury and therefore increase the probability of developing a labour-associated pressure injury5. Although historically the incidence of pressure injury in the maternity setting has been rare (<1%), it has also been suggested that the risk of tissue damage from pressure experienced by women in labour has been underestimated. Therefore, it is critical to not only understand the risk factors contributing to pressure injury in women during labour, but to identify effective prevention mechanisms that will enable healthcare providers to make the birthing process safer and more comfortable for mothers. In an attempt to address known risks factors around, the Canberra Hospital adapted a practice change resulting in the introduction of a new product to replace the existing moisture management product utilised throughout the hospital. However, the product did not meet the expecta8

tions of midwives caring for birthing women, indicating that new product was too small, potentially uncomfortable to lie on due to crinkling between the mattress and the skin surface, and that it did not adequately address moisture management at skin surface areas. Midwives also discussed the increased risk of occupational hazards, such as spills of excessive amniotic fluid and blood during the birthing process. These concerns prompted a meeting between the product manufacturer and hospital staff from the Centenary Hospital for Women & Children (CHWC) to design an improved product that would effectively control moisture during before, during, and after birthing. Through consultation and testing, a disposable absorbent sheet was specifically designed to address the requirements of maternity patients at the CHWC. This new product has three layers to manage moisture: an air permeable layer, an absorbent inner layer, and a breathable waterproof backing. It is designed to absorb moisture as well as wick moisture away from the patient’s skin, and it maintains these wicking properties regardless of the patient’s weight. Furthermore, the new product is larger than previous versions, accommodating the width of birthing beds and available with or without tuck-in wings. METHODS Study Design and Materials A prospective qualitative study using survey method was undertaken. The aim of this study was to determine whether the newly designed disposable absorbent sheet was suitable and effective for moisture management within this specialised clinical environment from the perspective of both women and clinicians. The research team developed staff and patients surveys based on a review of the current literature, in consultation with the maternity staff to assess their requirements for the new product. The surveys were similar, with minor relevant changes made to better align terminology with the group being surveyed. For example, patients were asked, “Which clinical area were you admitted to?” whereas midwives were asked, “Which clinical area were you working in?” The survey comprised multiple choice responses and free-text comments to assess four main factors: comfort, moisture management, mobility, and absorbency. Participants (both patients and midwives) were asked to rate comfort level from 0-10, with 10 being the most comfortable. To replicate current practice, the study compared the comfort level of a sanitary pad alone, the newly designed disposable absorbent sheet alone, or the absorbent sheet and sanitary pad together.

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Participants and Study Location This project was conducted during a five-week period in the maternity ward of the CHWC, a tertiary referral hospital within ACT Health. The CHWC employs approximately 130 midwives and nurses across the Birthing Suite (BS), Birthing Centre (BC), Antenatal (AN), and Postnatal (PN) units. The maternity unit is composed of 21 birthing, 15 postnatal, and 15 antenatal beds. Participants were patients in the BS, BC, AN, and PN units. Employed midwives and in-patients were recruited into this study and participation was voluntary. Midwives were asked to complete surveys to assess the comfort of the patients in their care. They were permitted to complete a survey for each woman under their care; therefore, individual midwives may have completed multiple surveys. Due to shift changes and the length of admission or labour, two midwives may have completed a survey related to caring for the same women. Women in each unit were invited to complete surveys to indicate their perception of the comfort level, moisture management ability, mobility, and absorbency of the product either during labour or after birth. As in current practice, patients could choose to use a sanitary pad alone, the newly designed disposable absorbent sheet alone, or the absorbent sheet together with a sanitary pad, and they were asked to comment accordingly. A Low Risk Ethics Application was submitted to ACT Health Human Research Ethics Committee (ACTHHREC) in July 2015. The response from this committee was that formal ethics approval was not required as the project met Quality Improvement Project Guidelines. Staff Education Prior to launching the study, the study coordinator held five staff in-services. The in-services detailed the study outline and staff members were given a copy of survey tool. Numerous ad hoc one-on-one education sessions were also conducted across the four clinical areas within the CHWC. Data Collection and Analysis Completed surveys were placed in collection boxes at various locations throughout the four clinical areas; surveys were then manually transcribed to an Excel spreadsheet and exported to IBM® SPSS Statistics v20 2011. Survey responses were placed into two groups: Birthing Units (BU) and Antenatal/Postnatal Wards (APW). Simple descriptive statistics were used to evaluate the new disposable absorbent sheet based on patient and midwife responses. To compare the comfort of the sanitary pad alone, the disposable absorbent sheet alone, and the absorbent sheet EWMA Journal 

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together with the sanitary pad, we used an ANOVA (reported as the scale mean (m) and standard error of mean (SEM)). Staff comments and feedback were analysed using descriptive thematic analysis. RESULTS During the five-week survey period, surveys were returned from a total of 93 midwives and 79 patients (n=172). Patient surveys were completed by 32% (n=25) of women admitted to the BU and 68% (n=54) from the APW. Midwife surveys were completed by 48% (n=45) of midwives working in the BU and 52% (n=48) of midwives working in APW. Women appeared to spend more time in bed in the APW. Based on midwife responses, 64% of women in the APW spent at least 8–12 hours in bed daily compared with 28% of woman in the BU. Women in the BU averaged between 4–8 hours in bed daily. These results highlight the need for effective skin care measures for these patients. Extended periods of time in bed pose a risk factor for skin damage and subsequent pressure injury. Additionally, these results support the relevance of our cohort in testing the efficacy of the new disposable absorbent sheet. Because participants rated comfort level on a scale, these results were reported separately from the other reported results. Patient Surveys: Comfort When rating the comfort level of the disposable absorbent sheet, women in both the BU and APW rated their comfort level highest when they used the disposable absorbent sheet in conjunction with sanitary pads, as opposed to the disposable absorbent sheet or sanitary pads alone (ANOVA scale mean (SEM): 8.40 (.26), 7.97 (.23), and 2.76 (.34), respectively; see Table 1). The majority 91% (n=72) of women felt most comfortable with the product over their bed sheet both during the day and at night. Participants (96%) commented that disposable absorbent sheets were “comfortable”, “unnoticeable”, “stayed flat”, and that the larger new absorbent sheet was “much better than the little ones”. Midwife Surveys: Comfort In contrast to the patient surveys, midwives in the BU did not perceive patient comfort level to be significantly different when the disposable absorbent sheet was used alone or in conjunction with a sanitary pad, or if only a sanitary pad was used [ANOVA scale mean (SEM): 8.31 (.24), 7.96 (.20), and 2.30 (.27), respectively], both were superior to a sanitary pad alone (see Table 1). However, midwives in the APW did indicate that using the disposable absorbent sheet in unison with sanitary pads was the most satisfactory method of supporting client comfort. Midwives comments about the new disposable absorbent 


pads included “more comfortable”, “stays still”, “wings comfy for longer use”, and “more comfortable for nonmobile women”.

able absorbent pad. A total of 78% (n=73) of midwives indicated that the disposable absorbent sheet promoted effective moisture management for the women in their care.

Patient Surveys: Moisture management Similar to results obtained when assessing product comfort, the majority 86% (n=68) of participants reported that moisture management most effective when using the disposable absorbent sheet together with sanitary pads. Nearly three-quarters of participants 73% (n=58) reported that the new product was effective for minimising stains on their clothing, making comments such as “the disposable absorbent sheet was comfortable and I felt confident knowing any leakage would be caught by this instead of bedding and/or stain my clothes”. Participants (84%) also responded that their skin had not felt sticky while lying on the disposable absorbent sheet (See Figure 1).

Midwives Survey: Mobility Midwives additionally indicated that the product was comfortable and did not restrict patient mobility, with positive response rates to both questions greater than 90% (See Figure 2). One midwife commented that the sheets were “Easy to roll and place under patient with wings, they don’t move with the patient, less folds and they are more comfortable for our women who have limited movement”.

Patient Surveys: Mobility and Absorbency Notably, due to maternal and birthing issues, 60% (n=47) of the participants spent more than 12 hours in bed in a 24-hour period, but 96% (n=76) indicated that they could find a comfortable position on the disposable absorbent sheet without requiring assistance. Over 60 % of participants suggesting the sheet need only be changed 8th hourly. Importantly, participant feedback highlighted that the patients felt that their dignity and privacy needs were maintained through using the disposable absorbent sheet. One participant stated; “The product is awesome, so easy to use I had peace of mind as would be embarrassed about leaking on sheets, comfortable directly next to skin, reassuring when limited clothes on”. Midwives Survey: Moisture Control Midwives participating in the study also had a positive perception of moisture control offered by the new dispos-

Midwives Survey: Absorbency The majority 66%, (n=62) of midwives reported having used the disposable absorbent sheet during a large spillage of body fluids (rupture of membranes or postpartum haemorrhage); while 85% (n=48) of these midwives indicated that the pad was able to efficiently absorb the bodily fluids, some indicated that it took some time to absorb a large spill (See Figure 2). For example, one midwife indicated that the product was “Particularly good with a birth and sudden loss of amniotic fluid great absorbency, much better at containing the fluid spill”. When asked how frequently the disposable absorbent sheet needed to be replaced, BU midwives reported changing the sheet every 2-4 hours, while APW midwives reported changing the sheet every 6-8 hours, on average. DISCUSSION Here we present the efficacy of a newly designed disposable absorbent sheet for moisture control among birthing women as perceived by both the patient and the caregiver. Patient survey responses indicate that the new product is effective at moisture control and reducing stickiness

Table 1: Comparison of patient and staff perceived comfort levels: Scale mean [SE]) Area (n)

Disposable absorbent sheet with Sanitary pad

Disposable absorbent sheet

Sanitary pad alone





Birthing Unit (25)

8.06 (.45)

7.14 (.44)

2.76 (.61)

Antenatal/Post Wards (54)

8.56 (.30)

8.35 (.25)

2.76 (.42)

Total (79)

8.40 (.26)

7.97 (.23)

2.76 (.34)



Birthing Unit (48)

7.77 (.37)

7.79 (.20)

2.59 (.37)

Antenatal/Post Wards (43)

8.93 (.23)

8.15 (.36)

1.96 (.38)

Total (91)

8.31 (.24)

7.96 (.20)

2.30 (.27)

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Figure 1: Midwives Satisfaction Survey 100 90

Respondans (%)

80 70 60 50 40 30 20 10 0 Provides effective moisture management

Supports client mobility

Supports client comfort

Effective in large spills

Birthing Units





Antenatal/Post Wards










while improving comfort before, during, and after birthing. Midwives similarly indicated that the product improves patient comfort, mainly by reducing moisture and controlling body fluid spillage, while not hindering patient mobility. Importantly, both women and midwives indicated that the product effectively controlled and facilitated clean-up of body fluid spills, suggesting that the product can reduce the risk of occupational hazards such as spillage of amniotic fluid or blood during birthing. This also has psychological implications for the patients, who have

expressed fear of embarrassment due to body fluids staining their clothing or bed linens, especially when visitors are present.3 Notably, 60% (n=47) of women surveyed stated that they had spent over 12 hours in bed during a single 24-hour period. This lack of mobility may be due in part to increased immobility associated with epidurals, which have been increasingly used over the past 30 years7 and are a î&#x201A;Š

Figure 2: Patient Satisfaction Survey 100

Respondans (%)

90 80 70 60 50 40 30 20 10 0 Absorbent sheet and pad most effective

Absorbent sheet minimised stains on clothing

Absorbent sheet aleviates stickness

Able to find comfortable postion on Absorbent sheet

Birthing Units





Antenatal/Post Wards










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recognised risk factor for development of pressure injuries among birthing women. Although traditionally the maternal wellbeing and birthing process has been treated as a wellness model, increased usage of pain control measures such as epidurals are causing a shift towards a medical model. Epidural-associated immobility increases the chance that women will experience a pressure injury, as long periods of pressure with impaired sensory perception place the patient at risk of a tissue injury. This highlights the need for standardised protocols and informed best practice procedures, which are currently lacking for maternity patients. We initiated this study due to the lack of informed best practice procedures in the maternity setting11 especially surrounding moisture control and pressure injury prevention in birthing women. Although this study provides important evidence for effective moisture control, and subsequently, pressure injury risk management, the actual risk for pregnant women to develop pressure injuries remains unknown, representing an important knowledge gap that needs to be filled by further study. Implications for Clinical Practice This product is the result of extensive collaboration between industry and clinicians. Although several articles have summarised the potential benefits of industry-clinician collaborations to develop products that effectively meet clinical needs, such collaborations are rare12,13,14. Our study, which summarises the design of a high-quality, clinically effective product through an industry-clinician partnership serves as a proof of principal for additional industry-clinician collaborations. Such collaborations are likely to pay large dividends in terms of improving patient quality of life, reducing caregiver burden, and, ultimately, reducing economic burden due to complications or unnecessarily extended hospital stays. Study Limitations This study was performed at a single hospital and included data collected from patients and midwives located at four different maternity wards. While surveys such as the one we employ here are cost-effective means for gathering feedback, they can only provide qualitative data in terms of patient and caregiver impressions of product performance. More rigorous studies are necessary to fully evaluate the performance of the disposable absorbent sheet in moisture control and, ultimately, prevention of pressure injuries.

ternity department at CHWC and is widely used in maternity facilities across Australia. The product is proving cost-effective for hospitals, as the cost difference between the new product and previous moisture control products is negligible, and its widespread use guarantees product availability from the manufacturer. We will re-evaluate the effectiveness of this product in twelve months to determine whether the results we obtained in our small-scale study are universal across Australian hospitals. Further studies necessary to evaluate product effectiveness in pressure injury prevention will also be facilitated by the widespread use of the product, and will be necessary to fully evaluate the utility of this product in maternal care. It may also be of interest to evaluate the efficacy of the disposable absorbent sheet for moisture control and pressure injury prevention in other groups at risk for pressure injuries, such as the elderly or oncology patients. Conclusions This industry-clinician collaborative effort led to a first of its kind innovative solution for moisture control in the maternity wards at CHWC which is now being widely used throughout Australia. Further research is needed to fully ascertain the specific risk for pregnant women to develop pressure injuries and to optimise pressure injury prevention in this group via moisture control and skin integrity maintenance. Acknowledgements We thank the CHWC midwives and patients that participated in this study, without whom this study would have been impossible. Data collection was funded through the Nursing and Midwifery Office of the Chief Nurse ACT Health as a 2015 Practice Development Grant. Trial products were provided by Haines Medical Australia. While we appreciate the support of Haines Medical Australia through the provision of product, we note that Haines Medical Australia did not have a role in study design or data analysis.

Future Directions Since completing the study, the disposable absorbent sheet has been further refined based on patient and midwife feedback. The sheet is now available throughout the ma-


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Implications for Clinical Practice n This study is a proof of concept for effective collaboration between industry and clinicians to improve patient care n The new product described not only improves patient quality life, but is also likely to reduce caregiver burden and associated healthcare costs n The new product may reduce the risk of occupational hazards, such as excessive spillage of amniotic fluid and/or blood during the birthing process

Further Research n Future research could evaluate the efficacy of this product for moisture control in other vulnerable groups at risk for pressure injury, such as the elderly or oncology patients

More studies are needed to fully evaluate the ability of the new moisture management product presented here to prevent pressure injury in birthing women n

REFERENCES 1. Dunk AM, Carville K. The international clinical practice guidelines for prevention and treatment of pressure ulcers/injuries. Journal of Advanced Nursing 2014; 72(2): 243-244.

5. Beeckman D. A decade of research on IncontinenceAssociated Dermatitis (IAD): Evidence, knowledge gaps and next steps. Journal of Tissue Viability http:// dx.doi.org/10.1016/j.jtv.2016.02.004 p 3-10.

2. Graves N, Zheng H. Modelling the direct health care costs of chronic wounds in Australia. Wound Practice and Research 2014; 1:20-33.

6. National Pressure Ulcer Advisory panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers; Clinical Practice Guideline. Emily Haesler (ed). Cambridge media: Perth, Australia; 2014; 42.

3. Dunk AM, Gardner A. Body shape: A predictor for pressure injury risk [online]. Wound Practice & Research: Journal of the Australian Wound Management Association 2016; 24: 92-98. 4. National Pressure Ulcer Advisory panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers; Clinical Practice Guideline. Emily Haesler (ed). Cambridge media: Perth, Australia. 2014; 21.

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7. Cheesman K, Makinde S, Bird G. Pressure ulcers in parturients. International Journal of Obstetric Anaesthesia 2010; 19 1: 121-122. 8. Bingham D. Setting perinatal quality and safety goals: should we strive for best outcomes. Midwifery 2010; 26: 483-484. 9. Pither C, Hartrick C, Prithvi P. Heel sores in association with prolonged epidural analgesia (comment). Anaesthesiology 1985; 63: 459.

10. Hughes C. Obstetric care. Is there risk of pressure damage after epidural anaesthesia? Journal of Tissue Viability 2001; 11 2: 56-58. 11. Carolan M, Hodnett E. ‘With woman’ philosophy: examining the evidence, answering the questions. Nursing Inquiry 2007; 14: 140–152. doi:10.1111/j.1440-1800.2007.00360.x 12. Pairman S, Thorogood C, Pincombe J, Tracy S. Midwifery: preparation for practice. Chatswood, NSW: Elsevier Australia (a division of Reed International Books Australia Pty Ltd). 2015; 818-909. 13. Morison B, Baker C. How to raise awareness of pressure sore prevention. British Journal of Midwifery 2001; 9(3): p 147-150. 14. Pritchard V. The development of a birthing Mattress. British Journal of Midwifery: 2002, 10(5): p280-283.


Sonoma Pharmaceu�cals Netherlands B.V. Boven de Wolfskuil 3, C30-C32 | 6049 LX Herten/Roermond | The Netherlands Phone: +31 (0)475 318 666 | Fax: +31 (0)475 318 342 info.europe@sonomapharma.com

Wound treatment for chronic- and acute wounds as well as first- and second degree burns



Science, Practice and Education

Advancing professional health care practice and the issue of accountability Until relatively recently in the United Kingdom, there has been a marked divide between the role of the doctor and that of the nurse. There were traditional roles for doctors and nurses, with doctors diagnosing and curing patients, and nurses caring for patients during this process. ABSTRACT This article is based on a presentation given at the 2016 Conference of the European Wound Management Association in Bremen Germany on 13 May 2016.

and nursing in particular, as a basis for discussion, the principles it examines are applicable to most countries where health care practitioners and their practices are regulated.

The aim of this article is to examine how health care practitioners can advance their practice. This article will consider traditional roles of health care practitioners, together with new and emerging roles; the limitations on professional practice; competence, and how it relates to the health care practitioner’s practice and its advancement; and the nature of accountability.

HEALTH CARE PRACTITIONER ROLES Traditional roles Until relatively recently in the United Kingdom, there has been a marked divide between the role of the doctor and that of the nurse. There were traditional roles for doctors and nurses, with doctors diagnosing and curing patients, and nurses caring for patients during this process.

The article adopts a perspective from the United Kingdom, using nursing as a case study, but the broad theoretical, legal, and regulatory perspectives presented are generally applicable across all areas.

Naughton & Nolan2 noted that nursing has a task-orientated focus, meaning that nurses undertake specific tasks, rather than having a role that allows them to use a holistic approach to their patients. This may in part be due to the focus on basic duties and tasks during pre-registration nurse training. Classically, at the point of registration, a nurse in the United Kingdom was considered competent to undertake a specific role, but if they wished to expand or extend that role, they had to undergo specific training to perform the new tasks.

Finally, this article concludes with a consideration of important guidelines for health care practitioners wishing to advance their practice.

INTRODUCTION The European Wound Management Association educational session at the 2016 Conference in Bremen Germany (13 May 2016) had the following main title: “To do or not to do,” and in the conference programme, this was noted as being an issue “that may evolve out of the fear of being held accountable for doing something”1. This article builds upon a presentation during that educational session, which examined how health care practitioners can expand their practice and how this affects their accountability. Although this article uses the United Kingdom, EWMA Journal 

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It was only in the 1970s that the situation began to change and nurses began to take a more holistic approach and extend the range of their roles. A key factor in the development of nursing roles was the publication of a circular from the Department of Health & Social Security3, which was supported by a joint document from the Royal College of Nursing and British Medical Association4. These two documents outlined what is involved in a 

Marc Cornock PhD, LLM, LLB (Hons), BA (Hons), BSc Senior Lecturer Faculty of Wellbeing, Education and Language Studies The Open University Address: Faculty of Wellbeing, Education and Language Studies The Open University Horlock Building Walton Hall Milton Keynes MK7 6AA

Correspondence to: marc.cornock@open.ac.uk Conflicts of interest: None


nurse’s basic training and what can be performed under the supervision of a doctor once the nurse had achieved competence in a particular skill or role. This allows doctors to delegate some roles and tasks to a nurse, and thus, for the nurse to extend their area of practice into areas once reserved for doctors, albeit under their supervision. New and emerging roles Health care is constantly changing, and what were once novel or cutting edge techniques 20 or 30 years ago, are now commonplace or even superseded by newer techniques. Likewise, there has been a dramatic change in the roles of health care practitioners. Many roles undertaken by health care practitioners today did not even exist 20 years ago. As a consequence, the boundaries that existed between doctors and nurses are blurred, and in some areas, broken; for instance, nurses now have the ability to prescribe independently of a doctor. Therefore, the modern health care practitioner role is constantly evolving and advancing, and the traditional role of nurses in the United Kingdom as carers - in deference to a doctor’s role in providing diagnosis and treatment - can be considered part of the past. LIMITATIONS ON PROFESSIONAL PRACTICE If, as suggested in the previous section, health care practitioners are changing the focus of their professional practice by taking on new roles and advancing the areas in which they practice, what should limit their practice? The obvious answer is the law and regulatory mechanisms that govern their area of expertise. However, as health care changes, the law is not always able to adapt simultaneously. 16

Therefore, both law and regulation often strive to keep up with changes in health care treatment and practice, as well as the roles of health care practitioners. Despite having to provide the framework within which healthcare practitioners can act, law and regulation often lag behind advances in the field. Thus, the legal and regulatory framework has to be one that is as permissive as it is restrictive in order to allow professional practices to develop, whilst at the same time ensuring that there are no detrimental effects to the care and treatment that patients receive. In the United Kingdom, it is often thought that someone has to be a doctor to treat a patient5. However, this is not true, as one does not have to be a registered health care practitioner. Interestingly, in the United Kingdom, anyone can treat an individual, provided they obtain the relevant consent and do not purport to have any qualification or registration that they do not possess, “even if they have no training in any type of healthcare whatsoever” (paragraph 5.9)5. What this means, for the United Kingdom at least, is that there are no overarching legal restrictions on the practice of health care; although, there are some legislative restrictions for certain treatments and procedures that require a doctor, including certifying death6, signing statutory sick certificates7, and performing abortions8. Additionally, only a doctor or midwife may attend a woman in childbirth9. Other factors that may limit a health care practitioner’s practice are those set out by their employer. Any employer will want to ensure that their employees are performing the duties for which they are employed. Therefore, a contract EWMA Journal 

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It allows doctors to delegate some roles and tasks to a nurse, and thus, for the nurse to extend their area of practice into areas once reserved for doctors, albeit under their supervision.

of employment will usually have some form of role description, outlining the duties expected of the employee and the scope of their practice. However, these role descriptions do not typically have explicit lists of tasks, procedures, or treatments that the health care practitioner may perform, but more often provide the context and structure within which the person may work. This means that these contracts allow the freedom for health care practitioners to work within specific parameters. Therefore, in response to the question of what limits the practice of a health care practitioner, the answer is the competence of the health care practitioner, unless there is a legal restriction on performing a particular procedure or prohibition by the employer. COMPETENCE The performance of health care practitioners often reflects their capabilities and competence; however, competence is more than performance - it also includes skill, ability, knowledge, and judgment10. For instance, it is possible for a health care practitioner to perform well under certain circumstances, but, if the practitioner is called upon to act in a slightly different way or in a different area, performance may deteriorate. Competence also involves “the judgment and discretion to be able to choose how to perform a particular task, which technique to utilise, when to undertake it and in what manner it should be used. The health care practitioner is able to judge when a particular task is outside of their level of competence and when to refer to another professional, or to decline the task altogether. Thus, the competent heath care practitioner does not need supervision as they can effectively superEWMA Journal 

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vise themselves” (Cornock M., unpublished PhD thesis, 2008). Indeed, the United Kingdom regulatory body for nurses, the Nursing and Midwifery Council, appears to endorse this view of competence, stating that competence is defined as “possessing the skills and abilities required for lawful, safe and effective professional practice without direct supervision”11. Together, this allows health care practitioners to assume safe effective practices, because, along with knowing their skills and abilities, they are equally able to understand their limitations. They are aware of when it is appropriate to perform a particular treatment or procedure or when a task is outside of their area of practice and to request assistance. In this way, there is a link between the expertise of health care practitioners and their competence: as their competence increases, so do their areas of expertise. The issue of competence as an essential feature that defines the area of a health care practitioner’s practice is illustrated by a landmark document issued by the United Kingdom Central Council for Nursing, Midwifery and Health Visiting (the then nursing and midwifery regulatory body) for nurses who were interested in advancing their practice. This position paper12 removed the requirement for nurses to undergo training and obtain certificates for procedures they had not been taught during their basic training. This meant that “nurses were able to decide, using their professional judgment, whether they had the necessary skills, knowledge and ability to undertake any procedure that was necessary for the care of their patients, and to decide what skills and knowledge they needed to develop their practice. 


Because it is one’s own competence that limits the area of practice, there must be some degree of accountability on the part of health care practitioners for their own practice.

practitioner is accountable to patients and their families; employers, who may dispense disciplinary action; the law, which may issue criminal charges and/or civil actions brought by patients; and the public, particularly through professional regulatory bodies, such as the General Medical Council and the Nursing and Midwifery Council.

ACCOUNTABILITY During question and answer sessions at conferences and workshops, this author found that when health care practitioners expressed concerns about accountability, they were typically most concerned about being held culpable for aspects of their practice and being sanctioned as a result.

ACCOUNTABLE TO WHAT STANDARD? If a health care practitioner is accountable for an aspect of their practice and could receive a sanction, there has to be some standard against which his or her practice can be judged so no arbitrary judgments are made about that practice.

Within the United Kingdom, many commentators and official documents use responsibility, accountability, and liability interchangeably, even though they actually refer to different concepts within the regulatory process. In this article, the term accountability is used to discuss how health care practitioners can be held culpable for their actions.

For health care practitioners within the United Kingdom, the standard of accountability is illustrated by multiple legal cases13,14. The current standard is to judge one health care practitioner against others. If there are multiple methods for performing a particular procedure or treatment, and a health care practitioner can demonstrate they used one of these methods and had a logical basis for their actions, they will likely meet the standard.

Where the nurse was confident of their competence, they were able to undertake that procedure”10.

Accountability refers to the practice of holding health care practitioners accountable for their actions, whether or not a mistake occurred in their practice. This also includes the possibility of sanctions being applied, which may include revoking a licence to practice if one’s practice is deemed to be below the required standard. The question that arises and was at the heart of the education session at the 2016 Conference of the European Wound Management Association is whether a health care practitioner should be concerned about accountability in advancing their practice. WHO IS ACCOUNTABLE? Legal and professional accountability in the United Kingdom rests with individual health care practitioners. If a health care practitioner is ‘asked’ or ‘ordered’ to perform a treatment, he or she is accountable for their own actions, regardless of whether they were acting as part of a team or on their own, although the individual who made the request may also be somewhat accountable. ACCOUNTABLE TO WHOM? There are some thirty-two bodies or organisations to which a health care practitioner is accountable in the United Kingdom (Cornock M., unpublished PhD thesis, 2008). Thus, the concerns of health care practitioners are justified by the sheer number of organisations that could hold them accountable. Although there are a large number of regulatory bodies within the United Kingdom, in essence a health care


One of the critical links between advancing practice and accountability is a standard of practice. This becomes important for advancing practice, where a health care practitioner is not necessarily evaluated against his or her own professional group (e.g., nurses judged against other nurses), but against those who are skilled in that particular treatment. For example, if a nurse performs procedures and treatments normally performed by a doctor or physiotherapist, they will be judged against the standard of a doctor or physiotherapist. Additionally, with the application of the standard of accountability in the United Kingdom, a health care practitioner is judged against “the ordinary skilled practitioner”13 (that is, someone who practises without advanced skills) and is not required to meet the standard of those holding the highest skill in that practice area. However, if a health care practitioner presents himself or herself as an expert or specialist, they will be judged against an expert or specialist in that practice area. Therefore, a health care practitioner who demonstrates competence and has a logical basis for his or her actions should easily achieve the standard of accountability to which they are being held. CONCLUSION Although this article has used nursing within the United Kingdom as the basis for a case study, there are a number of concluding points that are broadly applicable to most

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Science, Practice and Education

GUIDANCE FOR THOSE WISHING TO ADVANCE THEIR PRACTICE There are five key guidelines that health care practitioners wishing to advance their practice would be advised to heed:

1. Never work outside of your competence. If something is outside your level of competence, do not do it. Instead, obtain help, guidance, advice, and supervision from a competent practitioner.

2. Ensure the patient understands. Ensure that you speak with patients and keep them informed of who you are and what you are doing, and be certain they understand what they have heard.

3. Documentation is critical. Reliable records allow a consultation to be reconstructed without depending on memory. Records can protect an individual if they exist, but there is no way to demonstrate what occurred and what was done if records are not kept accurately.

4. If guidelines exist, have a very good reason for not following them. Guidelines indicate a standard procedure; disregarding guidelines may result in being considered below the required standard, unless there is a good explanation for not adhering to them.

5. If in doubt, seek advice. This is perhaps the single most important piece of advice recommended by this author: if in doubt seek advice, regardless of experience. From a legal and regulatory perspective, seeking advice will only improve a situation.

countries where health care practitioners and their practices are regulated.

competence, health care practitioners should not be afraid of advancing their practice.

Law and regulatory bodies assist health care practitioners with advancing their practices, and there is almost no limit to how one can advance his or her practice, provided that he or she is competent in those areas. All health care practitioners are accountable for their practice and the actions they take. Provided they work within their area of

ACKNOWLEDGMENTS I would like to acknowledge the questions and discussion I had with participants of the 2016 Conference of the European Wound Management Association that helped shape this article. I would also like to thank the two anonymous reviewers for their helpful and constructive comments.

REFERENCES 1. European Wound Management Association. 26th Conference of the European Wound Management Association Programme; 2016 May 11 – 13; Bremen, Germany.

5. United Kingdom. House of Lords Select Committee on Science and Technology Report on complementary and alternative medicine. London: The Stationery Office; 2000.

11. Nursing and Midwifery Council. The NMC code of professional conduct: standards for conduct, performance and ethics. London: Nursing and Midwifery Council; 2004.

6. Births and Deaths Registration Act 1953.

12. United Kingdom Central Council for Nursing, Midwifery and Health Visiting. Scope of professional practice. London: United Kingdom Central Council for Nursing, Midwifery and Health Visiting; 1992.

2. Naughton M. & Nolan M. Developing nursing’s future role: a challenge for the millennium. British journal of Nursing 1998; 7 (6): 983 – 986.

7. Social Security (Medical Evidence) Regulations 1976 (SI 1976/615).

3. United Kingdom. Department of Health and Social Security. Extended role for the nurse HC (77) 22. London: Department of Health and Social Security; 1977.

9. The Nursing and Midwifery Order 2001 (2002/253).

4. Royal College of Nursing & British Medical Association. The duties and position of the nurse. London: Royal College of Nursing & British Medical Association; 1978.

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8. Abortion Act 1967. 10. Cornock M. Clinical competency in children’s nursing: a legal commentary. Nursing Children and Young People 2011; 23 (10) 18 – 19.

13. Bolam v Friern Hospital Management Committee [1957] 2 All ER 11. 14. Bolitho v City & Hackney Health Authority [1998] AC 232. Note: UK statutes and other legislation can be found at: https://www.legislation.gov.uk/


Science, Practice and Education

The changing US healthcare climate:

What does it mean for wound care? The recent transition to a new Presidential administration in the US - and the ongoing health policy debates that have ensued - put the healthcare landscape into a state of flux, leaving many stakeholders in the wound care space wondering what is coming next. What impacts could the US’s new political landscape have on wound care patients and providers? What challenges will the US’s new value-basedcare payment system create for wound care? How could policy changes impact reimbursement pathways for wound care products? As Executive Director of the Alliance of Wound Care Stakeholders, I addressed these issues at the May 2017 European Wound Management Association’s plenary session “Change, opportunities and challenges - wound management in changing healthcare systems.” As part of this panel of international experts, I had the opportunity to share a US perspective on the current healthcare climate and its impact on wound care. SHARED TRENDS & CHALLENGES The US and Europe have significantly different healthcare systems; however, there are important global marketplace trends that impact the sector: aging population creates an increasing demand for medical products and services. n An

n This

increase is good for the industry and providers; however, it is coupled with increasingly cost conscious government and insurance payers. Cost-containment initiatives often lead to unfavourable payment rates and/or discretionary coverage policies.

n Therefore, we as physicans, clinicians and manufacturers need to demonstrate value to patients, payers and the health care system overall. n Currently, we need to focus on generating new types of data - especially for the wound care space - that demonstrate value using real world evidence.

we need to advocate effectively to ensure wound care issues are fairly addressed as policies are implemented and evolve. Having a united voice has never been more important. Advocacy is how we ensure patient access to quality care, ultimately leading to better outcomes.

n Similarly,

NEW ADMINISTRATION = NEW OPPORTUNITIES FOR ADVOCACY In the US, health policies are affected by many levels of government: the White House, Congress, and federal regulatory agencies. These regulatory agencies include the Department of Health and Human Services (HHS), which is the umbrella organisation that covers the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA). The initiatives of these regulatory agencies have the largest impact on wound care practices in the US. While our current Presidential Administration and its healthcare efforts have dominated headlines, the reality is that wound care practices in the US are not under any significant threat from the new Administration. In fact, the new heads of HHS, CMS and FDA bring extensive experience to the table, and their leadership could present new opportunities to advance and potentially fix 

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Marcia Nusgart Executive Director Alliance of Wound Care Stakeholders Contact: Alliance of Wound Care Stakeholders 5225 Pooks Hill Rd, Suite 627S Bethesda, MD 20814 Email: marcia@ woundcarestakeholders.org

Additional contact for editorial team: Shelley Ducker Communications, Alliance of Wound Care Stakeholders

Correspondence: sduckercommunications @gmail.com Conflicts of interest: None


MACR some of the regulatory challenges we have faced in the wound-care space (HCPCS-coding process, local coverage determinations, etc.).

system could create unique challenges for wound care providers as it evolves and is implemented through the CMS’s two Quality Payment Program reimbursement pathways: the Merit-Based Incentive Payment System and Alternative Payment Models. Currently, none of the obligatory quality, resource-use and clinical-performance reporting measures under MACRA are specific to wound care. Ultimately, the lack of reporting measures could impact Medicare reinbursement rates in the wound care space. The Alliance has been proactively engaging CMS policy makers and advocating for the addition of more wound care-specific measures as these payment programs evolve.

The new HHS Secretary, Tom Price, MD, is a retired surgeon and former Congressman. Who has a reputation for eliminating superfluous regulations and limiting federal involvement. We believe Sec. Price may be receptive to our concerns and advocacy. Seema Verma, the new CMS Administrator, is highly regarded and best known for her work on Medicaid-related issues. Scott Gottlieb, MD, the new FDA Commissioner, has a track record of favouring the industry and supporting faster drug approvals. Overall, these individuals could be good for the wound care sector. UNIQUE US TRENDS & CHANGES The seismic shifts in the US health sector are being driven by two recent pieces of legislation: n Medicare Access and CHIP Reauthorization Act (MACRA):

Enacted in 2015, MACRA is a driving force in the US’s shift to value-based care. This transformative law changes how US physicians and other clinicians are reimbursed. It creates a new framework for Medicare incentive payments that rewards clinicians for better care and consolidates quality reporting. This law would move reimbursement away from the “fee-forservice” model and toward a quality-measure-based coordinated-care model. However, this innovative new



21st Century Cures Act:

The goal of this act is to “bring our healthcare innovation infrastructure into the 21st century.” The Act advances personalized medicine and emphasises patientcentred outcomes and data. Importantly, it allows the FDA to streamline clinical trials, expands trial-design frameworks, and opens the door for the application of real-world evidence (RWE)—which could be particularly impactful in wound care space. Under the Act, the FDA has a mandate to issue guidance on the use of “complex adaptive and other novel trial design” frameworks and must consider the types of patient-driven quantitative and qualitative data that can be submitted for review. Many countries look to FDA paradigms to

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RA set their own guidance, so implementation of this Act could have global ramifications on trial designs moving forward. ADVOCACY FOCUS TODAY Our association of multi-disciplinary clinical organisations, the Alliance of Wound Care Stakeholders, is focused on promoting quality care and access to products and services for patients with wounds. We evaluate US health policies that impacts the wound care space. We bring together wound care clinicians, non-clinical entities, and manufacturers to advocate on regulatory, legislative, and public policy issues, such as coding, coverage, and reimbursement. These issues can create barriers to patients’ access to treatment or care. Over the years, we have successfully affected policy and legislation, demonstrating that collaborations between clinical associations and industry can work well together. Building on the trends outlined above, the priority areas for proactive wound care advocacy in the US include: n

MACRA Quality Measures:

MACRA creates unique challenges for wound care providers. Quality, resource-use, and clinical-performance measures—the reporting of which are obligatory for Medicare reimbursement under MACRA - may not truly reflect clinical decision making or the resources used

Science, Practice and Education

to treat wound patients. CMS’s list of quality measures fall into two categories: (a) those that can be used by all clinicians and (b) those that specifically apply to medical specialties. However, wound care is not designated as a medical specialty in the US. Thus, none of the initial measures that affect Medicare payments are wound care specific. The US Wound Registry has defined quality measures for wound care, but currently, these measures are not eligible for MACRA reporting. As such, wound care practitioners have to find a way to work with the available quality and documentation measures. At present, the Alliance is spearheading advocacy initiatives to educate policy makers about the importance of including quality measures that are meaningful in the wound care space. n

Optimising real-world evidence (RWE):

Randomized, controlled clinical trials do not always reflect the clinical realities of wound care. The 21st Century Cures Act opens the door to RWE and provides the wound care community with the opportunity to work together with manufacturers and regulatory agencies to establish RWE-driven pathways for FDA-approval of wound products and technologies. Looking ahead, the FDA has a mandate to hold public meetings on novel clinical trial design and RWE frameworks and to issue guidance on these topics. The guidance-development process will include multiple opportunities for stakeholder input, and the Alliance will proactively voice wound care concerns and identify opportunities. n Healthcare

Common Procedure Coding System (HCPCS) reform:

The system for obtaining a HCPCS code (which is used for billing a product under Medicare, Medicaid, and private health plans) lacks transparency, timeliness, and predictability. The process has had a chilling effect on innovation, therefore not allowing new technological developments for patients and ultimately compromising access to quality care. This system has created barriers to the coverage of and reimbursement for new products. Reform is needed to develop a meaningful code set that allows for uniform billing, has appropriate coverage and reimbursement policies, and gives patients access to quality care. The Alliance supports initiatives to reform the HCPCS-coding process by establishing greater transparency, and creating more opportunities for stakeholder input in the process. n Medicare Local Coverage Determination (LCD) transparency:

Most coverage policies for wound care in the US are set regionally by Medicare Administrative Contractors 

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Science, Practice and Education

(MACs). An increasing number of restrictive LCDs have impacted access to wound care therapies. The LCDdevelopment process lacks transparency, and the policies regularly cite outdated evidence that not based on current clinical practice standards. The Alliance has actively voiced concerns to CMS. The US Congress recognised that the LCD-development process needs improvement and included provisions in the 21st Century Cures Act to “increase transparency around the LCD process and begin the process of bringing greater accountability.” This provision requires that MACs provide stakeholders with information, including a response to submitted comments, a summary of the evidence considered during LCD development, and an explanation of the rationale supporting coverage determination. Additional legislation to improve MAC transparency and accountability was introduced in the US Senate (S.794) and in the House of Representatives (H.R. 3635). The Alliance is proactively developing strategies to support and strengthen this legislative initiative.

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CONCLUSION There are several unifying elements needed to navigate the changes in both the US and European health systems: Venue

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(1) Relationships matter. Knowing decision makers in

regulatory agencies and government is critical for successful advocacy. (2) Quality evidence. Providing high-quality evidence is more important now than ever. It is needed to demonstrate value and for manufacturers to obtain coverage and reimbursement for medical products.

The Alliance unifies the voice of the wound care clinician community and helps navigate and proactively address prospective policy issues. We leverage our collective power to ensure that wound care has visibility and a seat at the regulatory table during healthcare policy development and decision making. Looking to the future, we and our members are ready to tackle the issues of importance to the wound care community. We look forward to keeping EWMA and its members informed of our progress. Keep up to date on our ongoing US wound care advocacy issues and the Alliance’s initiatives at www.woundcarestakeholders.org.

Main Topics


Soft tissue infections






Organization, setting and education


Wound closure strategies


Charcot – diagnosis and treatment


Critical limb ischemia


Clinical cases


Poster and free paper sessions

See the full programme and register on www.a-dfs.org

REFERENCES 1. Caspersen F, Gottrup F, Mathiesen D, Brockdorff A. Sårteam - Organisering af et behandlingstilbud til patienter med problemsår - en medicinsk teknologivurdering. 1st ed. Sundhedsstyrelsen: Sundhedsstyrelsen, Center for Evaluering og Medicinsk Teknologivurdering; 2006. 2. Moffatt C, Vowden K, Price P, Vowden P. Psychosocial factors and delayed healing. In: Moffatt C, Vowden P, Aug


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Closing wounds. Together.

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Science, Practice and Education

Meeting Report: Core outcome set for Venous leg ulceration “CoreVen”

Sarah Hallas1

Andrea Nelson1

Report from CoreVen meeting in Amsterdam 4 May 2017

INTRODUCTION The Core outcome set for Venous leg ulceration (CoreVen) project was established in 2016 and is registered on the COMET database (http://www. comet-initiative.org/studies/details/680). The project aims to develop a minimum list of outcomes on the effectiveness of interventions used in venous leg ulceration (VLU) and their associated measurement instruments for reporting in clinical trials. The principal investigators are Prof. Andrea Nelson (University of Leeds, UK) and Dr Georgina Gethin (NUI Galway, Ireland). Sarah Hallas is a PhD student on the project, and Mary Burke is an MSc Student. Supervision of these students is provided by Dr Susan O’Meara (University of Leeds), Prof. Andrea Nelson, and Dr Georgina Gethin. The steering group represents a range of disciplines from multiple European countries: Dr Una Adderley (Lecturer and Researcher in Community Nursing, University of Leeds, UK), Dr Jan Kottner (Scientific Director of Clinical Research for Hair and Skin Science, Department of Dermatology and Allergy, Charite-Universitatsmedizin Berlin, Berlin, Germany), Dr Mary Madden (Lecturer and Researcher in Applied Health Research, University of Leeds, UK), Dr Pauline Meskell (Senior lecturer and researcher at the Nursing and Health Research Department, University of Limerick, Ireland), Prof. Jane Nixon (Deputy Director Institute Clinical Trials Research, University of Leeds, UK), Dr Aonghus O’Loughlin (Consultant Endocrinologist, Bons Secours Hospital, Galway, Ireland and an Alliance for Research

and Innovation in Wounds Steering Committee Member), Prof. Sebastian Probst (Professor of Tissue Viability and Wound Care, University of Applied Sciences Western Switzerland, Geneva, Switzerland and Council Member and Editor, EWMA), Mr Wael Tawfick (Vascular Surgeon Saolta University Health Care Group, University Hospital Galway, and the School of Medicine, National University of Ireland Galway, Ireland, and an Alliance for Research and Innovation in Wounds Steering Committee Member), and Dr Thomas Wild (General Surgeon, specialising in wound management and septic surgery, University Medical Center Hamburg-Eppendorf, Germany and Editor-in-Chief, Wound Medicine). AIMS OF THE MEETING The aim of the meeting was to introduce the project, its rationale, its purpose, and progress to date as well as to gain feedback on the proposed methodology. The project team members are grateful to the EWMA for facilitating this first open meeting. ATTENDANCE AT THE MEETING Notification of the meeting was provided in the conference programme and on the website and was therefore open to all delegates. Key opinion leaders in VLU management who were attending the conference were informed of the meeting, and pre-conference notifications were sent to contacts. A total of 52 people attended the meeting from various backgrounds, which included patient organisation representatives, vascular surgeons,

Susan O’Meara1

Georgina Gethin2,3

1 School

of Healthcare, University of Leeds, Leeds, UK

2 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland 3 Alliance

for Research and Innovation in Wounds

Correspondence: hc11s4h@leeds.ac.uk Conflicts of interest: None

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physicians, dermatologists, podiatrists, nurses, sociologists, and researchers. BACKGROUND A core outcome set (COS) is a minimum set of outcomes that should be measured and reported in all clinical trials for a specific clinical area as agreed on by stakeholders in that field1. An outcome is any identifiable consequence of the exposure to a health care intervention, such as a drug or a dressing. An outcome must be appropriate, measurable, and meaningful to stakeholders. COS are gaining recognition as a means of improving the potential for metaanalysis within systematic reviews and ultimately synthesising results of trials that include outcomes of importance to patients and key stakeholders. A COS also reduces the risk of outcome-reporting bias2. For example, in the absence of these minimum requirements, the presentation of findings may be limited to outcomes with statistically significant results. The implementation of the COS for VLUs by researchers will increase the utility of trials in this field and facilitate comparison amongst different sources of evidence. Many areas of healthcare have developed a COS, such as the Outcome Measures in Rheumatology (OMERACT;3), the management of Otitis Media with Effusion in children with cleft palate (mOMEnt;4), and Harmonizing Outcome Measures for Eczema (HOME;5). To date, however, no standardised methods of assessment or COS exist for VLU management, and three previous systematic reviews have identified the diversity of outcomes in RCTs in this field6,7,8. A recent qualitative study9 that aimed to identify the most important outcomes for complex wounds from the perspectives of patients, carers, and healthcare professionals found that most patients with VLUs, including intravenous drug users, and healthcare professionals involved in their care regarded the healing of the wound as the primary treatment goal. Patients were greatly troubled by the social consequences of having a complex wound. Thus, the CoreVen project team is working together to develop a minimum list of outcomes for VLU trials. A VLU is a chronic wound that occurs below the knee and takes more than six weeks to heal9. A VLU is a chronic and reoccurring condition11 that is caused by impaired venous blood flow triggered by venous hypertension. The prevalence of VLUs has been estimated at 0.29 per 1000 individuals in the UK (95% confidence interval 0.250.33)12. Estimates in the Western world suggest that 1% of the population experience VLUs, and this rate could be as high as 3% in people over the age of 65 years13. Venous hypertension results in damage to the valves in the legs, allowing two-way blood flow to occur instead of the normal


one-way flow of blood and resulting in swelling of the leg veins, oedema, and leakage of circulatory fluid into the surrounding tissue from the capillaries in the lower legs14. VLU can result in pain, malodour, susceptibility to infection, and lack of mobility15. These issues, in turn, affects the patient’s quality of life through reduction in social activity, limits on their capacity to work, and inability to perform self-care and personal hygiene activities9,16. In order to ensure individuals receive good quality care and treatment supported by evidence-based practice, effective treatments must be developed and rigorously tested. The lack of consistency in clinical trial outcomes means that it is difficult to compare results of clinical trials or to perform meta-analysis6. This lack of consistency limits clinical judgments, as trials often have numerous and different outcomes. Often the choice of outcomes is not carefully considered as many of the outcomes are not regarded as important by patients. The use of these outcomes in clinical trials has led to waste in study resources and reporting, and these issues may be avoidable with the use of a COS2. Another challenge is that different trials use different measurement instruments at different time points and often with little reference to the validity and reliability of such instruments6. These issues underscore the need to develop COS and appropriate measurement instruments for clinical trials for VLU treatment. While no single method of developing a COS is accepted, a multi-stage process in which all stakeholders, including patients and their carers, contribute to the final outcome set will be the most useful. Firstly, a core domain set is established. This step is followed by development of a consensus minimal set of outcomes that should be reported for any trial. Finally, consensus on how the outcomes are to be measured with respect to validity and reliability of the measurement instruments is achieved amongst the participating stakeholders. DEVELOPMENT OF COS IDENTIFICATION OF POTENTIAL OUTCOMES Scoping review The results of a scoping review, which included all outcomes identified in the Cochrane Systematic Review database that included RCTs in patients with VLU, were presented at the meeting. A scoping review enabled the concepts in a field of interest to be ‘mapped’ out17 and allowed for a rapid underpinning of the key concepts18. The adaptation of the Arksey and O’Malley17 five-stage methodological framework for conducting a scoping review by Levac et al.19 was used to guide the review. Stage 1 identified the research question, which although broad, still includes the study population. In this case, the study

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population included people with VLUs. Stage 2 identified the relevant studies, which were RCTs included in the Cochrane systematic reviews. Stage 3 defines the study selection. Levac et al19 recommended that the inclusion and exclusion criteria can be applied post hoc as the researcher becomes increasingly familiar with the literature. The charting of the data (Stage 4) was designed according to the framework analysis of Ritchie and Spencer20. In this stage, the outcomes were organised into a structured table that facilitated the grouping of the outcomes into domains. The results were collated, summarised, and reported in Stage 5.

n The

In total, 807 (post-deduplication) potential outcomes were extracted. Through consensus amongst the group members, these 807 outcomes were grouped into 11 domains (Table) and presented at the meeting. Domains are broad, descriptive categories that host potential groupings of several, more specific, outcomes.

n An audience member highlighted the fact that an online

Table: Domains identified following the scoping review. n n n n n n n n n n n

Healing Patient-reported symptoms Clinician-reported symptoms Carer-reported symptoms Life impacts Clinical signs Clinical measurement Performance of the intervention Resource use: supplies Resource use: clinician time Adverse events

CONSENSUS METHODS DISCUSSION The method to be used to gain consensus from stakeholders was openly discussed at the EWMA meeting. The following topics were introduced, and agreement was achieved. n Stakeholders will include patients, carers, health profes-

sionals, policy makers, researchers, and industry representatives. Two members (Nelson and O’Meara) of the project team are editors for Cochrane Wounds Group (CWG), ensuring the involvement of a broad range of stakeholders. Other steering group members also have expertise in Cochrane Reviews. We are also likely to contact additional people who contribute to the CWG (e.g., review authors and editors) through the proposed networks. EWMA Journal 

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Delphi method will be used via an online survey tool (Bristol Online Survey) to gain consensus on the domains. Participants will be asked to rate each domain in terms of importance on a Likert scale of 1 to 9 (1 being not important, and 9 being extremely important). Discussion with the audience suggested that most people were in favour of including two rounds for each step of the consensus process. The rationale behind this is that it is methodologically defensible. That is, with two rounds, we will be able to better identify and understand the complexities of the decision process, in agreement with processes for other COS21.

format has methodological limitations and may be limited in its ability to reach the patient group. This challenge was discussed and acknowledged by the team. Because of funding restraints, however, it will not be possible to send out paper copies of the survey. Paper formats are also much more time consuming. The survey will benefit from the ‘snowball’ effect, in that the number of people that have the opportunity to participate will be increased via links from wound care organisations and all other known networks with an interest in VLU research; however, individuals will not be contacted by their National Health Service (NHS) UK use or employment. Ethical approval for this step has been sought from the University of Leeds, UK. n It

was suggested that ulcer recurrence should be considered an outcome. The initial response from the team was that ulcer recurrence was not included in this COS initiative, as the focus of the COS was the treatment of open VLUs. Following an in-depth discussion, the group concluded that ulcer recurrence will not be included as a domain or outcome. Unfortunately, the scope of this project cannot cover all aspects of VLU management, especially in light of the fact that the scoping review of open ulceration has revealed that this by itself is a significant endeavour.

n An

audience member asked whether there will be representation from the healthcare industry. Following an in-depth discussion after the meeting at EWMA, it was decided that healthcare industry representatives will be part of the stakeholder group.

n Additional

issues that will not be addressed within the scope of the project were addressed. The CoreVen project aims to develop the COS only and will not be advising on the conduct and reporting of trials; however, we highlight the need for future research on the conduct and reporting in VLU trials. The following issues were discussed: 


n The

idea that the COS should include recommendations about duration of follow-up was suggested. This idea was discussed based on the criticisms raised in the systematic review by Hodgson et al.22, in which a median follow-up of 12 weeks was suggested for trials evaluating treatments for chronic wounds. A later comment reiterated that recommendation for a minimum follow-up time for assessment of both healing and recurrence within that period would be useful. Our group, however, will not be recommending a minimum followup time; however, we do emphasise that future research on the minimum follow-up time is needed.

n Members

of the audience suggested that trials should report baseline prognostic variables per group. While the COS will not cover such recommendations, the COS, once established, can be implemented alongside tools, such as CONSORT (Consolidated Standards of Reporting Trials, 23), which includes recommendations on the reporting of baseline variables, to address this issue.

n A question was posed regarding whether the COS would

provide guidance on the target number of trial participants. The team responded by stating the COS will recommend outcomes on which estimations of statistical power would be based but would not recommend a target number for trial participants directly as this number depends on the individual trial aims. n Members

of the audience questioned how the steering group decided on a 70% level of consensus (as opposed to other values). The team responded that this decision was based on methods used by other COS initiatives, such as OMERACT24, which developed COS in rheumatology; Kirkham et al.25, who developed the COSSTAR (Core Outcome Set-STAndards for Reporting) statement; McNair et al.26, who developed COS in colorectal cancer surgery; and Millar et al.21, who developed COS in prescribing for older adults in care homes.

n The

core outcome(s) may vary according to trial endpoint and the treatment being evaluated. The team responded to this point by stating that the aim of the initiative is to identify core outcomes for all VLU trials and that trialists can certainly add other outcomes. The core outcome may be a secondary outcome within a study and does not necessarily have to be a primary outcome.

n An audience member also said that researchers involved

in future studies should be able to justify the reasons that outcomes from the COS were not reported in the trial.


CONCLUSION The meeting was successful as the audience raised valuable questions and provided helpful comments during the meeting to facilitate the development of the COS. In conclusion, industry stakeholders will be accessed through their identified networks. Researchers will be able to include additional outcomes in their studies, will be able to decide which of the COS are primary and secondary in their trials, and will be able to omit some outcomes as long as they provide justification. As with all initiatives, some issues will not be covered by the scope of the project because the CoreVen project aims to develop the COS only and will not be advising on the conduct and reporting of trials. The team, however, emphasises the need for future research on conduct and reporting in VLU trials. This includes recommendations on the minimum follow-up time, baseline prognostic variables, and number of trial participants. A two round online survey that will soon be launched will seek to gain consensus on the domains listed (see Table). Following this survey which is to gain consensus on the domains, an additional online survey will be completed in two rounds to gain consensus on the specific outcomes that fall within the domains that were voted as important in the previous online survey. WHAT IS NEXT? The online survey will be launched in September/October 2017, and the team aims to complete the two rounds of data gathering by December 2017. The findings will be ready for presentation in early 2018. A second meeting will be held in 2018 to discuss the findings and finalise the method for the second Delphi study on the core outcomes. The full protocol will be published and made readily available. You can contact us: Email: Sarah Hallas via hc11s4h@leeds.ac.uk Twitter: @VLUcoreven Nonstandard abbreviations CONSORT Consolidated Standards of Reporting Trials CoreVen Core outcome set for Venous leg ulceration COS Core Outcome Set COS-STAR Core Outcome Set- STAndards for Reporting CWG Cochrane Wounds Group EWMA European Wound Management Association HOME Harmonizing Outcome Measures for Eczema mOMEnt management of Otitis Media with Effusion in children with cleft palate NHS National Health Service OMERACT Outcome Measures in Rheumatology RCT Randomised Control Trial VLU Venous Leg Ulceration

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Dr Una Adderley1 Dr Jan Kottner5 Dr Mary Madden1 Dr Pauline Meskell6 Prof. Jane Nixon4 Dr Aonghus O’Loughlin3,7 Prof. Sebastian Probst8 Mr Wael Tawfick3,7,9 Dr Thomas Wild10,11,12,13

4 Clinical

Trials Research Unit, School of Medicine, University of Leeds, UK

10 University Medical Center HamburgEppendorf, Germany

5 Charite-Universitatsmedizin Berlin, Berlin, Germany

11University of Applied Science Anhalt, Institute of Applied Bioscience and Process Management

6 The Department of Nursing and Midwifery, University of Limerick, Limerick, Ireland 7 Saolta

1 School

University Health Care Group, University Hospital Galway, Galway, Ireland

2 School

8 University of Applied Sciences Western Switzerland, Geneva, Switzerland

of Healthcare, University of Leeds, Leeds, UK

of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland 3 Alliance

for Research and Innovation in

9 School of Medicine, National University of Ireland Galway, Galway, Ireland


of Plastic, Hand and Aesthetic Surgery, Medical Center Dessau, Academic Teaching Hospital of Marin Luther University of HalleWittenburg, Germany


of Dermatology, Immunology and Allergology, Medical Center Dessau, Academic Teaching Hospital of Marin Luther University of Halle-Wittenburg, Germany

Wounds REFERENCES 1. COMET. COMET Initiative. [Internet]. 2017. [Cited 2017 Aug 08]. Available from: http://www.cometinitiative.org/ 2. Williamson, P. R., Altman, D. G., Bagley, H., Barnes, K. L., Blazeby, J. M., Brookes, S. T., Clarke, M., Gargon, E., Gorst, S., Harman, N., Kirkham, J. J., McNair, A., Prinsen, C. A. C., Schmitt, J., Terwee, C. B. and Young, B. The COMET Handbook: Version 1.0. Trials. [Internet]. 2017. [Cited 2017 Aug 08]. 18 (suppl 3):280. Available from: https://trialsjournal. biomedcentral.com/articles/10.1186/s13063-0171978-4 3. Boers, M., Kirwan, J. R., Wells, G., Beaton, D., Gossec, L., d’Agostino, M-A., Conaghan, P. G., Bingham III, C. O., Brooks, P., Landewe, R., March, L., Simon, L. S., Singh, J. A., Strand, V. and Tugwell, P. Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0. Journal of Clinical Epidemiology. [Internet]. 2013 [Cited 2017 Aug 08]. 67(7), pp. 745-753. Available from: http://www. sciencedirect.com/science/article/pii/ S0895435613004885 4. Bruce, I., Harman, N., Williamson, P., Tierney, S., Callery, P., Mohiuddin, S., Payne, K., Fenwick, E., Kirkham, J. and O’Brien, K. The management of Ottis Media with Effusion in children with cleft palate (mOMEent): a feasibility study and economic evaluation. Health Technology Assessment. [Internet]. 2015. [Cited 2017 Aug 16]. 19(68), pp.1-408. Available from: https://www.journalslibrary.nihr.ac.uk/hta/hta19680/#/full-report 5. Schmitt, J., Apfelbacher, C., Spuls, P. I., Thomas, K. S., Simpson, E. L., Furue, M., Chalmers, J. and Williams, H. C. The Harmonizing Outcome Measures for Eczema (HOME) Roadmap: A methodological framework to develop core sets of outcome measurements in dermatology. Journal of Investigative Dermatology. [Internet]. 2015. [Cited 2017 Aug 08]. 135(1), pp. 24-30. Available from: http://www. jidonline.org/article/S0022-202X(15)37064-0/pdf 6. Gethin G, Killeen F, Devane D. Heterogeneity of wound outcome measures in RCTs of treatments for VLUs: a systematic review. Journal of Wound Care. May 2015. 24(5):211-226. 7. Hodgeson, R., Allen, R., Broderick, E., Bland, J. M., Dumville, J., Ashby, R., Bell-Syer, S., Foxlee, R., Hall, J., Lamb, K., Madden, M., O’Meara, S., Stubbs, N. and Cullum, N. Funding source and the quality of reports of chronic wounds. Trials. [Internet]. 2014. [Cited 2017 Aug 16]. 15(19), pp. 1-10. Available from: https://trialsjournal.biomedcentral.com/track/ pdf/10.1186/1745-6215-15-19?site=trialsjournal. biomedcentral.com 8. Lazarus, G., Valle, F., Malas, M., Qazi, U., Maruthur, N. M., Doggett, D., Fawole, O. A., Bass, E. B. and Zenilman, J. Chronic venous leg ulcer treatment: future research needs. Wound Repair and Regeneration. [Internet]. 2014. [Cited 2017 Aug 16]. 22(1), pp. 34-42. Available from: http://onlinelibrary.wiley. com/doi/10.1111/wrr.12102/epdf

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9. Cullum, N., Buckley, H., Dumville, J., Hall, J., Lamb, K., Madden, M., Morley, R., O’Meara, S., Saramago Goncalves, P., Soares, M. and Stubbs, N. Wounds research for patient benefit: a 5 year programme of research. Health Technology Assessment. [Internet]. 2016. [Cited 2017 Aug 29]. Pp. 1-334. Available from: http://eprints.whiterose.ac.uk/105570/1/ FullReport_pgfar04130.pdf 10. NHS. Leg Ulcer, Venous. [Internet]. 2012. [Cited 2017 Aug 08]. Available from: http://www.nhs.uk/ conditions/Leg-ulcer-venous/Pages/Introduction.aspx 11. National Institute for Health and Care Excellence (NICE). Leg ulcer- venous. [Internet]. 2016. [Cited 2017 Aug 08]. Available from: http://cks.nice.org.uk/ leg-ulcer-venous#!backgroundsub:1 12. Hall, J., Buckley, H. L., Stubbs, N., Saramago, P. Dumville, J. C. and Cullum, N. A. Point prevalence of complex wounds in a defined United Kingdom population. Wound Repair and Regeneration. [Internet]. 2014. [Cited 2017 Aug 16]. 22(6), pp. 694-700. Available from: http://onlinelibrary.wiley. com/doi/10.1111/wrr.12230/full 13. Gohel, M. S. and Poskitt, K. R. Venous ulceration. In: Donnelly, R. and London, N. J. M .eds. ABC of Arterial and Venous Disease. Chichester: WileyBlackwell. 2009. P 84. 14. O’Meara, S. Martyn-St James, M. and Adderley, U. J. Alginate dressings for venous leg ulcers (Review). Cochrane. [Internet]. 2015. [Cited 2017 Aug 08]. Available from: http://onlinelibrary.wiley.com/ doi/10.1002/14651858.CD010182.pub3/epdf/ standard 15. Nelzon, O., Bergqvist, D. and Lindhagen, A. Venous and non-venous leg ulcers: clinical history and appearance in a popular study. British Journal Surgery. [Internet]. 1994. [Cited 2017 Aug 08]. 81(2), pp. 182-187. Available from: http://onlinelibrary.wiley.com/doi/10.1002/bjs.1800810206/epdf 16. Herber, O. R., Schnepp, W. and Riegger, M. A. A systematic review on the impact of leg ulceration on patients’ quality of life. Health and Quality of Life Outcomes. [Internet].2007. [Cited 2017 Aug 08]. 5(44), pp. 1-12. Available from: http://hqlo. biomedcentral.com/articles/10.1186/1477-7525-5-44 17. Arksey, H. and O’Malley. Scoping Studies: Towards a Methodological Framework. International Journal of Social Research Methodology. [Internet]. 2005. [Cited 2017 Aug 08]. 8(1), pp. 19-32. Available from: http://www.tandfonline.com/doi/ pdf/10.1080/1364557032000119616 18. Mays, N., Roberts, E. and Popay, J. Synthesising research evidence. In Fulop, N., Allen, P., Clarke, A. and Black, N. (eds). Studying the organisation and delivery of health services: Research methods. London: Routledge. 2001

20. Ritchie, J. and Spencer, L. Qualitative data analysis for applied policy research. In: Bryman, A. and Burgess, R. G. (eds) Analyzing qualitative data. London: Routledge. 1994. pp.173-194 21. Millar, A, N., Daffu-O’Reilly, A., Hughes, C. M., Alldred, D. P., Barton, G., Bond, C. M., Desborough, J. A., Myint, P. K., Holland, R., Poland, F. M. and Wright, D. Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes. Trials. [Intenet]. 2017. [Cited 2017 Aug 08]. 18(175), pp. 1-12. Available from: http://download.springer.com/static/pdf/43/art% 253A10.1186%252Fs13063-017-1915-6.pdf?origin Url=http%3A%2F%2Ftrialsjournal.biomedcentral.com 22. Hodgson, R,. Allen, R., Broderick, E., Bland, M. J., Dumville, J. C., Ashby, R., Bell-Syer, S., Foxlee, R., Hall, J., Lamb, K., Madden, M., O’Meara, S., Stubbs, N. and Cullum, N. Funding source and the quality of reports of chronic wounds trials: 2004-2011. Trials [Internet]. 2014. [Cited 2017 Aug 08]. 15(19), pp. 1-10. Available from: http://eprints.whiterose.ac. uk/77620/7/Funding%20source%20and%20 quality%20of%20wounds%20trials_with_coversheet. pdf 23. CONSORT. Explanation and Elaboration Document. [Internet]. 2010 [Cited 2017 Aug 08]. Available from: http://www.consort-statement.org/Media/ Default/Downloads/CONSORT%202010%20 Explanation%20and%20Elaboration%20(BMJ).pdf 24. OMERACT. The OMERACT handbook. [Internet]. 2017 [Cited 2017 Aug 08]. Available from: https:// www.omeract.org/pdf/OMERACT_Handbook.pdf 25. Kirkham, J. J., Gorst, S., Altman, D. G., Blazeby, J. M., Clarke, M., Devane, D., Gargon, E., Moher, D., Schmitt, J., Tugwell, P., Tunis, S. and Williamson, P. R. Core Outcome Set-STandards for Reporting: The COS-STAR Statement. Plos Medicine. [Internet]. 2016. [Cited 2017 Aug 08]. pp. 1-11. Available from: http://journals.plos.org/plosmedicine/article/ file?id=10.1371/journal. pmed.1002148&type=printable 26. McNair, A. G., Whistance, R. N., Forsythe, R. O., Macefield, R., Rees, J., Pullyblank, A. M., Avery, K. N., Brookes, S. T., Thomas, M. G., Sylvester, P. A., Russell, A., Oliver, A., Morton, D., Kennedy, R., Jayne, D. G., Huxtable, R., Hackett, R., Dutton, S. J., Coleman, M. G., Card, M., Brown, J. and Blazeby, J. M. Core Outcomes for Colorectal Cancer Surgery: A Consensus Study. Plos Medicine [Internet]. 2016. [Cited 2017 Aug 08]. pp. 1-14. Available from: http://journals.plos.org/plosmedicine/article/ file?id=10.1371/journal. pmed.1002071&ttyp=printable

19. Levac, D., Colquhoun, H. and O’Brien, K. K. Scoping studies: advancing the methodology. Implementation Science. [Internet]. 2010 [Cited 2017 Aug 08]. 5, pp. 1-9. Available from: http://download.springer. com/static/pdf/239/art%253A10.1186%25 2F1748-5908-5-69.pdf?originUrl=http%3A%2F%2Fi mplementationscience.biomedcentral.com


It’s time for

© 2016 Ferris Mfg. Corp. 5133 Northeast Pkwy Fort Worth, TX 76106 USA Unless otherwise indicated, all trademarks are owned by or licensed to Ferris. MKL-702-I R0 0316


Negative Pressure Wound Therapy:

The text „Negative Pressure Wound Therapy: Future Perspectives“ was published spring 2017 as a chapter included in the EWMA Document “Negative Pressure Wound Therapy: Overview, Challenges and Perspectives”.

Future Perspectives

The text is inspired by and draws on knowledge developed in the SWAN-iCare project, which was completed in April 2017 with a successful final review by the European Commission. A final report describing the achievements of the project will be published on the SWANiCare website.

Excerpt from the EWMA Document “Negative Pressure Wound Therapy: Overview, Challenges and Perspectives”. Published by EWMA in spring 2017

1 Department of Endocrinology, University Hospital of Malmö


TECHNOLOGICAL DEVELOPMENTS Technological advances within NPWT are currently seen to be heading in several directions. Hospital-based system with increased sophistication Hospital-based devices are developing in the direction of increased sophistication and in the delivery of adjunct therapies such as saline irrigation/instillation, either intermittently or continuously with NPWT1-4. The benefits of powerful antimicrobial solutions for wounds with a high bioburden are under intense investigation5-7. In another related direction, the delivery of alternative active substances such as insulin8 or doxycycline9 are being investigated, as yet on a non-commercial (offlabel-use) basis. Simplified single use devices On the other hand, there is a substantial development, almost as it were in the opposite direction, in the use of simplified single-use NPWT devices10-16. This movement, which includes both electrically powered and mechanically powered devices, recognises the benefits of the accessibility of NPWT “off-the-shelf ” and a lower cost base. This permits the widespread adoption of singleuse devices in the emerging prophylactic use of EWMA Journal 

2017 vol 18 no 2


Jan Apelqvist1,2 (editor) Christian Willy3 (co-editor) Ann-Mari Fagerdahl4 Marco Fraccalvieri5 Malin Malmsjö6 Alberto Piaggesi7 Astrid Probst8 Peter Vowden9

SWAN-iCare is partially founded under the seventh Research and Innovation Framework programme FP7 by the European Commission.

Introduction In this paper we aim to reflect on where technological developments within NPWT seem to be going and continue to discuss some of the main clinical and organisational aspects that can be expected to influence future spread and uptake of NPWT in clinical practice.



NPWT to reduce complications, such as dehiscence or infection, when used over closed surgical incisions17,18. In addition, single-use devices do not restrict patient mobility as they are small in dimension and self-contained. New material for wound fillers The properties of the wound dressing or wound interface determine most of the effects of NPWT on the wound bed. The currently used wound fillers are commonly foam or gauze. The interaction between the wound dressing and the wound bed has been described in detail for foam and gauze19. Both these wound fillers cause a mechanical effect on the wound. The tissue surface is stimulated by the structure of the wound dressing. This will trigger the cells to divide to rebuild and strengthen the tissue. The amount and character of granulation tissue formed may differ between the two dressings. The use of foam as a wound interface in NPWT produces thick, hypertrophic granulation tissue. Gauze under NPWT results in less thick but dense granulation tissue19,20. There are other differences in properties between foam and gauze in that the porous structure of foam allows greater volume reduction under pressure. The effect on the wound is also dependent on the size of the foam or amount of gauze filler, e.g. a higher tissue pressure i achieved by a small foam filler compared to a large foam filler21. In the instances when the wound bed is covered 

Division for Clinical Sciences, University of Lund

3 Department of Trauma & Orthopedic Surgery, Septic & Reconstructive Surgery, Bundeswehr Hospital Berlin 4 Department of Clinical Science and Education, Karolinska Institutet, and Wound Centre 5 Plastic Surgery Unit, ASO Città della Salute e della Scienza of Turin 6

Clinical Sciences, Lund University

7 Department of Endocrinology and Metabolism, Pisa University Hospital 8

Kreiskliniken Reutlingen GmbH


Faculty of Life Sciences, University of Bradford, and Honorary Consultant Vascular Surgeon

Correspondence: ewma@ewma.org The document is supported by unrestricted educational grants from: Acelity, BSN medical, Genadyne, Mölnlycke Health Care, Schülke & Mayr GmbH, Smith & Nephew and Spiracur.



by a wound contact layer, the micro deformational effect is lessened compared to when the foam or gauze is in direct contact with the wound bed, which will affect granulation tissue formation. One novel wound filler is a bacteria and fungus binding mesh. It produces a significant amount of granulation tissue in the wound bed, more than with gauze, without the problems of ingrowth, as is the case with foam22,23. Like gauze, bacteria and fungus binding mesh has the advantage of being easy to apply to irregular and deep pocket wounds. In addition, efficient wound fluid removal in combination with its pathogen binding properties makes hydrophobic mesh an interesting alternative wound filler in NPWT22,23. There are vast possibilities for further development of novel wound fillers and this will presumably focus on tailoring the compressibility of the wound filler for altering the effect on wound contraction (or macro deformation). Attempts have been made on altering the pore sizes in the wound filler. There is also an opportunity for development of the surface structure of the wound filler in order to tailor the micro deformational effect on the wound bed, to hinder ingrowth in the wound filler or even to make the dressing material resorbable. Systems with integrated sensors for long-distance monitoring Next generation NPWT are devices seen to be incorporating sensors with the ability to continuously measure selected wound parameters and some form of basic remote communication capabilities. The use of different types of wound sensors combined with technologies that are able to analyse and process this data will make it possible to collect, record and analyse data streams quickly and accurately over time and in this way be capable of identifying early signs of infections, and specific bacteriaâ&#x20AC;&#x2122;s and point out direction for personalized therapy24,25. The use of sensors and remote communication facilities holds potential benefits and is stated to be able to increase the quality of care delivered, reduce costs and improve access to specialized care for people living in remote places. The quality of care is improved by the availability of prompt and detailed clinical outcome data that will allow the healthcare provider to define an optimal and timely treatment pathway and to possibly accelerate the healing of the patient. Savings are to be achieved through the possibility of taking preventive actions and avoiding acute and severe complications due to delays in diagnosis.


Better access to care is achieved for people living in remote areas since this will allow for specialist attention towards the care given at a distance. The remote monitoring function could also lead to better compliance in the community care setting to the treatment prescribed since deviances can be promptly discovered and addressed. Another positive effect of these distant linkages between community carers and specialist care is the learning opportunity for community nurses achieved through ongoing feed-back from in-hospital specialists. The ability to measure and collect continuous data on the development of different wound parameters also holds potential in terms of collecting BIG data for research due to the possibility of pooling individual outcome data. This type of device holds great potential but there are still some essential development challenges to be addressed before we can expect to see these devices available in clinical practice. Some of the biggest challenges appear, to be not so much related to what is technologically possible but more about what wound parameters are the most importance to gather data on in order to impact wound healing. Furthermore, more research on critical thresholds and time intervals for the measurements of these variables, in addition to a clearer understanding of how the interaction of various wound parameters should be interpreted, is critical to establish if the data should add value to clinical practice. This information needs to come from clinical research and be fed into the technical developers. Once this information is available, it seems that, despite the fact that there is still some way to go, most issues of a technical nature could feasibly be solved26. In summary, NPWT devices could be seen as heading in three directions: increasingly complex devices for specialist applications within the hospital, progressively simpler devices for lower cost settings such as the out-patient clinic or the home, and sensor-based devices with remote communication technologies to be used for distant monitoring. It is yet unclear as to what the ultimate proportions of patients will be treated with each type of device. CHANGES IN DEMAND â&#x20AC;&#x201C; SUPPORTING AND CONSTRAINING FACTORS How advanced and technological appealing a device might be is not the only determinant of how popular a medical device will be, as several stakeholders in the health care delivery system will have the potential to influence whether or not a medical device is adopted into routine care or not. Payers at various levels of the system as well as clinicians and patients are driven by different rationales. There are several theories and models that describe and explain the underlying mechanism of the determinants behind diffusion of innovations; however, the evidence EWMA Journalâ&#x20AC;&#x201A;

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of it is complex27. The selected topics highlighted here are not based on a thorough and systematic analysis of the decisional environment around NPWT but simply based on a general impression among the authors of the document as to what are the main issues that seem to be affecting and influencing future uptake of NPWT. Expanded indications The technological developments in NPWT have already led to expansions of the indications of what types of wounds can benefit from NPWT treatment, compared to what was originally envisioned for NPWT devices first arriving in clinic. As examples the availability of smaller, single-use disposable pumps has meant that new types of wounds can be treated (small, surgical) and in new settings such as short-term home care28. Adding to this, the new interventions underway as described above may even further contribute to the increased uptake. Increased focus on evidence and cost containment Health care providers are increasingly asking for evidence of a treatment’s clinical effectiveness if they are going to provide reimbursement. In addition to this some health care systems are also starting to require health economic analyses providing an economic cost calculation in favour of the treatment mode. The clinical benefits of NPWT in varied wound types has been reported in over 1000 peer-reviewed articles, and NPWT has been described as the gold standard in some areas of wound care. However, there is as yet no definitive clinical evidence supporting NPWT as a better and faster method for wound healing than the use of advanced dressing28. This lack of strong evidence has several explanations. NPWT is a generic multimodal technology that can deliver a broad range of treatment goals depending on the patient being treated and these goals can be achieved by altering a range of variables which all add to the complexity of studying the therapy as part of an RCT. The strict inclusion criteria in RCTs lead to recruitment problems and in turn limit real-world relevance and reproducibility28. When it comes to cost estimations, the natural variations in treatment outcomes combined with variations in treatment regimens depending on e.g. wound type, size, and amount of exudate makes it very difficult to come up with a solid figure that can be universally applied across health care settings, wound types and patients. Underlying figures of importance for such calculations such as duration of treatment, number and frequency of dressing changes, training required, in combination with great variations in pricing models offered by the companies delivering the products are only examples of some of the key figures EWMA Journal 

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expected to vary between each individual case. This lack of strong evidence could potentially become a hindrance for health care providers’ access to use NPWT as health authorities and payers are increasingly focusing on prioritization and shifting of resources to treatment areas where a strong clinical evidence and health economic rationale can be proven. This is already the case in England where “The National Institute for Health and Care Excellence” (NICE) is well established and in Scandinavia where similar set ups are being discussed at political level. Also at the level of the individual clinicians the lack of evidence in some instances makes care givers reluctant to use this mode of therapy28. On this background it becomes evident that the current problems relating to lack of high level evidence supporting the clinical effectiveness of NPWT on different types of wounds can prove to become be an important hindrance in terms of getting reimbursement for the treatment and hereby pose an important barrier to get access to treatment with NPWT. Thus for the use of NPWT to gain in popularity and receive backing from health care systems in the form of continued reimbursement the issue of providing strong evidence needs to be addressed. Changes in organisation of care and community care A major and general trend across health care settings around Europe is an increased move of specialized health care services from in hospital, ambulatory and acute health care settings to community care. Length of in hospital stay decreases and patients are transferred early to community care. This means that more complex and exudating wounds that would previously have been managed and taken care of by specialised staff in hospitals are now being cared for by community care nurses in the home setting. This in combination with the availability of smaller lightweight and disposable devices has led to an increased use of NPWT in community settings. Also the development within sensors based systems with remote communication facilities might further support introduction of NPWT in community care settings. To guarantee optimal usage of NPWT in community settings future emphasis must focus on how to ensure that more nurses that do not have direct access to specialist doctors for expert advice are able to handle the products correctly and are compliant to the prescribed treatment regimes. This requires training and availability of reliable support systems with easy access. If these aspects are not carefully dealt with this might impact treatment out



comes and potentially undermine the backing of the use of NPWT in the long run. Also, the education of patients and caregivers becomes even more central when treatment with NPWT shifts towards the outpatient setting. Studies show that patients express the need for thorough education in managing the treatment29,30. Therefore, it is important to educate patients and caregivers and not only to inform them, which requires a structured teaching program. Digital platforms and tools for self-treatment where patients and health care personnel can communicate while being treated at home, development of telemedicine in the treatment with NPWT is an interesting aspect for the future. Another important aspect of this shift to community care is the adding of yet another complex layer of payer structures and decision making processes. The question about who will pay for the treatment, and when, will become even more complex to map as the answer to the question will differ according to the specific setup. This complexity

and unclear roles of responsibilities might in the end affect the patients. It may delay appropriate care and lead to reluctance between decision making levels to take on the final responsibility of providing the most optimal treatment if perceived expensive. In some cases it might not be the one having to pay for the treatment that will ripe the potential economic benefit of providing it. This shift of responsibility for more specialised care to community settings therefore calls for a need to rethink reimbursement models and furthermore increase pressure on safety aspects and training needs. In the case of adoption of systems with remote monitoring facilities implementation barriers related to integration with existing EHR systems, changing care patterns ( e.g. insufficient staffing or time to monitor and follow up on data) and professional roles (e.g. clarify legal liability of responsibilities etc.) will need to be addressed to be successful31.

REFERENCES 1. Raad W, Lantis JC, 2nd, Tyrie L, Gendics C, Todd G. Vacuum-assisted closure instill as a method of sterilizing massive venous stasis wounds prior to split thickness skin graft placement. Int Wound J. 2010;7(2):81-5.

11. Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011;6:160.

2. Fluieraru S, Bekara F, Naud M, Herlin C, Faure C, Trial C, et al. Sterile-water negative pressure instillation therapy for complex wounds and NPWT failures. J Wound Care. 2013;22(6):293-4, 6, 8-9.

12. Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013;57(3):791-5.

3. Kim PJ, Attinger CE, Oliver N, Garwood C, Evans KK, Steinberg JS, et al. Comparison of Outcomes for Normal Saline and an Antiseptic Solution for Negative-Pressure Wound Therapy with Instillation. Plast Reconstr Surg. 2015;136(5):657e-64e.

13. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: a multicenter randomized controlled trial. Wound Repair Regen. 2012;20(3):332-41.

4. Kim PJ, Attinger CE, Steinberg JS, Evans KK, Lehner B, Willy C, et al. Negative-pressure wound therapy with instillation: international consensus guidelines. Plast Reconstr Surg. 2013;132(6):1569-79.

14. Hudson DA, Adams KG, Van Huyssteen A, Martin R, Huddleston EM. Simplified negative pressure wound therapy: clinical evaluation of an ultraportable, no-canister system. Int Wound J. 2015;12(2):195201.

5. Lehner B, Fleischmann W, Becker R, Jukema GN. First experiences with negative pressure wound therapy and instillation in the treatment of infected orthopaedic implants: a clinical observational study. Int Orthop. 2011;35(9):1415-20. 6. Back DA, Scheuermann-Poley C, Willy C. Recommendations on negative pressure wound therapy with instillation and antimicrobial solutions - when, where and how to use: what does the evidence show? Int Wound J. 2013;10 Suppl 1:32-42. 7. Matiasek J, Djedovic G, Mattesich M, Morandi E, Pauzenberger R, Pikula R, et al. The combined use of NPWT and instillation using an octenidine based wound rinsing solution: a case study. J Wound Care. 2014;23(11):590, 2-6. 8. Scimeca CL, Bharara M, Fisher TK, Kimbriel H, Mills JL, Armstrong DG. Novel use of insulin in continuousinstillation negative pressure wound therapy as “wound chemotherapy”. J Diabetes Sci Technol. 2010;4(4):820-4. 9. Scimeca CL, Bharara M, Fisher TK, Giovinco N, Armstrong DG. Novel use of doxycycline in continuous-instillation negative pressure wound therapy as “wound chemotherapy”. Foot Ankle Spec. 2010;3(4):190-3. 10. Gabriel A, Thimmappa B, Rubano C, Storm-Dickerson T. Evaluation of an ultra-lightweight, singlepatient-use negative pressure wound therapy system over dermal regeneration template and skin grafts. International Wound Journal. 2013;10(4):418-24.


15. Nordmeyer M, Pauser J, Biber R, Jantsch J, Lehrl S, Kopschina C, et al. Negative pressure wound therapy for seroma prevention and surgical incision treatment in spinal fracture care. Int Wound J. 2015. 16. Holt R, Murphy J. PICO incision closure in oncoplastic breast surgery: a case series. Br J Hosp Med (Lond). 2015;76(4):217-23. 17. Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013;145(5):1387-92. 18. Pellino G, Sciaudone G, Selvaggi F, Canonico S. Prophylactic negative pressure wound therapy in colorectal surgery. Effects on surgical site events: current status and call to action. Updates Surg. 2015;67(3):235-45. 19. Borgquist O, Gustafsson L, Ingemansson R, Malmsjo M. Micro- and macromechanical effects on the wound bed of negative pressure wound therapy using gauze and foam. Ann Plast Surg. 2010;64(6):78993. 20. Fraccalvieri M, editor Negative pressure wound therapy using the gauze and the foam: immunohistological and ultrasonography morphological analysis of the granulation tissue and the scar tissue. Preliminary report of a clinical study presented at the 3rd Congress CORTE 4-6 March 2010. . Conferenza Italiana per lo studio e la Ricerca sulle ulcere, piaghe, ferite e riparazione tessutale (CORTE); 2010.

21. Anesater E, Borgquist O, Hedstrom E, Waga J, Ingemansson R, Malmsjo M. The influence of different sizes and types of wound fillers on wound contraction and tissue pressure during negative pressure wound therapy. Int Wound J. 2011;8(4):33642. 22. Malmsjo M, Ingemansson R, Lindstedt S, Gustafsson L. Comparison of bacteria and fungus-binding mesh, foam and gauze as fillers in negative pressure wound therapy--pressure transduction, wound edge contraction, microvascular blood flow and fluid retention. Int Wound J. 2013;10(5):597-605. 23. Malmsjo M, Lindstedt S, Ingemansson R, Gustafsson L. Use of bacteria- and fungus-binding mesh in negative pressure wound therapy provides significant granulation tissue without tissue ingrowth. Eplasty. 2014;14:e3. 24. Salvo P, Dini V, Di Francesco F, Romanelli M. The role of biomedical sensors in wound healing. Wound Medicine. 2015;8:15-8. 25. Consortium Si. SWAN iCare Project Objectives http:// www.swan-icare.eu/en/objectives2016 [cited 2016. Available from: http://www.swan-icare.eu/en/ objectives 26. Pantelopoulos A, Bourbakis NG. A survey on wearable sensor-based systems for health monitoring and prognosis. IEEE Transactions on Systems, Man, and Cybernetics, Part C (Applications and Reviews). 2010;40(1):1-12. 27. Hall BH, Khan B. Adoption of new technology. National bureau of economic research; 2003. 28. Ousey KJ, Milne J. Exploring portable negative pressure wound therapy devices in the community. Br J Community Nurs. 2014;Suppl(SUPPL. 3):S14, S6-20. 29. Fagerdahl AM, Bostrom L, Ottosson C, Ulfvarson J. Patients’ experience of advanced wound treatment-a qualitative study. Wounds. 2013;25(8):205-11. 30. Fagerdahl A-M, editor The Patient’s Conceptions of Wound Treatment with Negative Pressure Wound Therapy. Healthcare; 2014: Multidisciplinary Digital Publishing Institute. 31. Davis MM, Freeman M, Kaye J, Vuckovic N, Buckley DI. A systematic review of clinician and staff views on the acceptability of incorporating remote monitoring technology into primary care. Telemedicine and e-Health. 2014;20(5):428-38.

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Different for a reason


Intelligent exudate lock-in


Designed to lock in exudate and to minimize the risk of skin damage.1,3 • High fluid handling – absorbs under pressure across a range of viscosities. Absorbs vertically.*1-4 • Hyper-absorbent fluid lock-in design – locks away exudate. Minimizes risk of maceration.1,3,5,6

*smith&nephew ALLEVYN™ LIFE NON-BORDERED Foam Dressing

• Unique five layer conformable shape with low tack silicone – cuttable, easy to apply and remove.7-9


Supporting healthcare professionals

References: 1. Smith & Nephew Data on File DS.16.328.R v2 ALLEVYN LIFE Non-Bordered physical testing. 2. Smith & Nephew Data on File DS.16.334 v2 ALLEVYN LIFE Non-Bordered Fluid Uptake Testing. 3. Smith & Nephew Data on File DS.16.470.R ALLEVYN LIFE Non-Bordered horizontal wound model. 4. Smith & Nephew Data on File DS.16.469.R ALLEVYN LIFE Non-Bordered Vertical Wound Model. 5. Rossington et al (2013) Clinical performance and positive impact on patient wellbeing of ALLEVYN LIFE. WOUNDS UK. Vol 9. No.4. 6. Fairlamb D. (2017) ALLEVYN LIFE Non-Bordered Clinical Claims Supporting Statement. 7. Smith & Nephew Data on File DS/16/429/R Shedding when cut – Testing on ALLEVYN LIFE non-Bordered and DURAFIBER dressings. 8. Smith & Nephew R&D Report RD.17.047 – ALLEVYN LIFE Non-Bordered Flexibility and Conformability 9. Weedon. F (2016) ALLEVYN LIFE Non-Bordered Human Factors summary. *Based on proven performance on wound model data. ™Trademark of Smith & Nephew. All Trademarks acknowledged © August 2017 Smith & Nephew. 10848

Cochrane Reviews

ABSTRACTS OF RECENT ­COCHRANE REVIEWS Publication in The Cochrane Library Issue 5, 2017

Therapeutic ultrasound for venous leg ulcers Nicky Cullum, Zhenmi Liu Citation example: Cullum N, Liu Z. Therapeutic ultrasound for venous leg ulcers. Cochrane Database of Systematic Reviews 2017, Issue 5 . Art. No.: CD001180. DOI: 10.1002/14651858.CD001180. pub4. ABSTRACT Background: Venous leg ulcers are a type of chronic, recurring, complex wound that is more common in people aged over 65 years. Venous ulcers pose a significant burden to patients and healthcare systems. While compression therapy (such as bandages or stockings) is an effective first-line treatment, ultrasound may have a role to play in healing venous ulcers. Objectives: To determine whether venous leg ulcers treated with ultrasound heal more quickly than those not treated with ultrasound. Search methods: We searched the Cochrane Wounds Specialised Register (searched 19 September 2016); the Cochrane Central Register of Controlled Trials (CENTRAL; the Cochrane Library 2016, Issue 8); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations, MEDLINE Daily and Epub Ahead of Print) (1946 to 19 September 2016); Ovid Embase (1974 to 19 September 2016); and EBSCO CINAHL Plus (1937 to 19 September 2016). We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. Selection criteria: Randomised controlled trials (RCTs) that compared ultrasound with no ultrasound. Eligible non-ultrasound comparator treatments included usual care, sham ultrasound and alternative leg ulcer treatments. Data collection and analysis: Two authors independently assessed the search results and selected eligible studies. Details from included studies were summarised using a data extraction sheet, and double-checked. We EWMA Journal 

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attempted to contact trial authors for missing data. Main results: Eleven trials are included in this update; 10 of these we judged to be at an unclear or high risk of bias. The trials were clinically heterogeneous with differences in duration of follow-up, and ultrasound regimens. Nine trials evaluated high frequency ultrasound; seven studies provided data for ulcers healed and two provided data on change in ulcer size only. Two trials evaluated low frequency ultrasound and both reported ulcers healed data. It is uncertain whether high frequency ultrasound affects the proportion of ulcers healed compared with no ultrasound at any of the time points evaluated: at seven to eight weeks (RR 1.21, 95% CI 0.86 to 1.71; 6 trials, 678 participants; low quality evidence - downgraded once for risk of bias and once for imprecision); at 12 weeks (RR 1.26, 95% CI 0.92 to 1.73; 3 trials, 489 participants; moderate quality evidence - downgraded once for imprecision); and at 12 months (RR 0.93, 95% CI 0.73 to 1.18; 1 trial, 337 participants; low quality evidence - downgraded once for unclear risk of bias and once for imprecision).

Gill Rizzello Managing editor Cochrane Wounds, School of Nursing, Midwifery and Social Work, University of Manchester.

One trial (92 participants) reported that a greater percentage reduction in ulcer area was achieved at four weeks with high-frequency ultrasound, while another (73 participants) reported no clear difference in change in ulcer size at seven weeks. We downgraded the level of this evidence to very low, mainly for risk of bias (typically lack of blinded outcome assessment and attrition) and imprecision. Data from one trial (337 participants) suggest that high frequency ultrasound may increase the risk of non-serious adverse events (RR 1.29, 95% CI 1.02 to 1.64; moderate quality evidence - downgraded once for imprecision) and serious adverse events (RR 1.21, 95% CI 0.78 to 1.89; moderate quality evidence downgraded once for imprecision). It is uncertain whether low frequency ultrasound affects venous ulcer healing at eight and 12 weeks (RR 3.91, 95% CI 0.47 to 32.85; 2 trials, 61 participants; very low quality evidence -downgraded for risk of bias and imprecision). High-frequency ultrasound probably makes little or no difference to quality of life (moderate quality evidence, downgraded for imprecision). The outcomes of adverse 

Correspondence: gill.rizzello@ manchester.ac.uk More information: www.wounds.cochrane.org Conflicts of interest: None


effects, quality of life and cost were not reported for low-frequency ultrasound treatment. Authors’ conclusions: It is uncertain whether therapeutic ultrasound (either high or low frequency) improves the healing of venous leg ulcers. We rated most of the evidence as low or very low quality due to risk of bias and imprecision.

Plain language summary Can ultrasound therapy help to heal venous (varicose) leg ulcers and/or improve symptoms? What are venous leg ulcers, and who is at risk? Venous leg ulcers are common wounds caused by damage or blockages in leg veins. This leads to pooling of blood and increased pressure in these veins. Eventually these changes can damage the skin and underlying tissue and form a long-lasting wound, or ulcer. These ulcers can be painful and leak fluid. They can also become infected. People at risk of developing venous leg ulcers include the elderly and those with mobility problems. They can be distressing for patients and costly to healthcare systems. Why use ultrasound to treat leg ulcers? Treatments for venous leg ulcers include compression bandages, which improve blood-flow in the legs, wound dressings, and medication such as antibiotics. Ultrasound therapy is sometimes used as an additional intervention, especially for difficult, longstanding ulcers. Sound waves are passed through the skin causing the tissue underneath to vibrate. The mechanisms by which ultrasound waves interact with healing tissues are not fully understood; they may have a positive or negative impact on the blood flow around the ulcers. We wanted to discover whether using ultrasound therapy can improve the healing of leg ulcers. What we found? In September 2016 we searched for randomised controlled trials (RCTs) that investigated whether ultrasound helps to heal or improves the symptoms of venous leg ulcers. We found 11 trials involving a total of 969 participants. The average (mean) age of participants ranged from 59 years to 70 years. The proportion of female participants ranged from 55% to 79%. Eight studies compared ultrasound with use of no ultrasound for venous leg ulcers and the other three compared ultrasound with sham ultrasound. Seven out of the eleven studies were at high risk of bias and we could not assess the potential bias in three studies due to poor reporting. One study was at low risk of bias. The trials were all different, for example in their duration of follow-up (three weeks to 12 months), and the strength of the ultrasound waves used (high or low frequency ultrasound). It is not clear from this evidence whether ultrasound (high or low frequency) increases the healing of venous leg ulcers. The results of one study (337 participants) suggest that high-frequency ultrasound may be associated with more adverse events such as pain and skin redness (moderate quality evidence). The two studies that evaluated lowfrequency ultrasound did not report whether participants experienced side effects. It is also uncertain whether either high- or low-frequency ultrasound affects participants’ quality of life. Quality of the evidence Most of the studies we found did not have many participants, had short follow-up times and had weaknesses of study design 40

that meant they were quite likely to give a misleading result. We consider the available evidence to be low quality due to these risks of bias. This plain language summary is up to date as of September 2016.

Nasal decontamination for the prevention of surgical site infection in Staphylococcus aureus carriers Zhenmi Liu, Gill Norman, Zipporah Iheozor-Ejiofor, Jason KF Wong, Emma J Crosbie, Peter Wilson Citation example: Liu Z, Norman G, Iheozor-Ejiofor Z, Wong JKF, Crosbie EJ, Wilson P. Nasal decontamination for the prevention of surgical site infection in Staphylococcus aureus carriers. Cochrane Database of Systematic Reviews 2017, Issue 5. Art. No.: CD012462. DOI: 10.1002/14651858.CD012462. pub2. ABSTRACT Background: Surgical site infection rates in the month following surgery vary from 1% to 5%. Due to the large number of surgical procedures conducted annually, the costs of these surgical site infections (SSIs) can be considerable in financial and social terms. Nasal decontamination using antibiotics or antiseptics is performed to reduce the risk of SSIs by preventing organisms from the nasal cavity being transferred to the skin where a surgical incision will be made. Staphylococcus aureus (S aureus) colonises the nasal cavity and skin of carriers and can cause infection in open or unhealed surgical wounds. S aureus is the leading nosocomial (hospital-acquired) pathogen in hospitals worldwide. The potential effectiveness of nasal decontamination of S aureus is thought to be dependent on both the antibiotic/antiseptic used and the dose of application; however, it is unclear whether nasal decontamination actually reduces postoperative wound infection in S aureus carriers. Objectives: To assess the effects of nasal decontamination on preventing surgical site infections (SSIs) in people who are S aureus carriers undergoing surgery. Search methods: In September 2016 we searched the Cochrane Wounds 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 Plus. We also searched three clinical trials registries and the references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. Selection criteria: Randomised controlled trials (RCTs) which enrolled S aureus carriers with any type of surgery and assessed the use of nasal decontamination with antiseptic/antibiotic properties were included in the review. Data collection and analysis: Two review authors independently performed study selection, data extraction, risk of bias assessment and GRADE assessment. EWMA Journal 

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Cochrane Reviews

Main results: We located two studies (291 participants) for inclusion in this review. The trials were clinically heterogeneous with differences in duration of follow-up, and nasal decontamination regimens. One study compared Mupirocin (2% contained in a base of polyethylene glycol 400 and polyethylene glycol 3350) with a placebo in elective cardiac surgery patients; and one study compared Anerdian (iodine 0.45% to 0.57% (W/V), chlorhexidine acetate 0.09% to 0.11% (W/V)) with no treatment also in cardiac surgery patients. The trials reported limited outcome data on SSI, adverse events and secondary outcomes (e.g. S aureus SSI, mortality). Mupirocin compared with placebo: This study found no clear difference in SSI risk following use of Mupirocin compared with placebo (1 trial, 257 participants); risk ratio (RR) 1.60, 95% confidence interval (CI) 0.79 to 3.25 based on 18/130 events in the Mupirocin group and 11/127 in the control group; low-certainty evidence (downgraded twice due to imprecision). Anerdian compared with no treatment: It is uncertain whether there is a difference in SSI risk following treatment with Anerdian compared with no treatment (1 trial, 34 participants); RR 0.89, 95% CI 0.06 to 13.08 based on 1/18 events in the Anerdian group and 1/16 in the control group; very low certainty evidence (downgraded twice due to imprecision and once due to risk of bias). Authors’ conclusions: There is currently limited rigorous RCT evidence available regarding the clinical effectiveness of nasal decontamination in the prevention of SSI. This limitation is specific to the focused question our review addresses, looking at nasal decontamination as a single intervention in participants undergoing surgery who are known S aureus carriers. We were only able to identify two studies that met the inclusion criteria for this review and one of these was very small and poorly reported. The potential benefits and harm of using decontamination for the prevention of SSI in this group of people remain uncertain.

bacteria, and their noses can be cleaned with anti-bacterial products (antibiotics and antiseptics) before the operation. This can help reduce the growth of bacteria. We wanted to find out if this nasal decontamination is effective in reducing SSIs, and whether people had any adverse reactions to this treatment, such as skin irritation. Study characteristics: In September 2016 we searched for randomised controlled trials (RCTs) involving nasal decontamination for preventing SSI. We included two studies with 291 participants, all adults undergoing cardiac surgery. The anti-bacterial products used for cleaning the nose were Mupirocin (antibiotic cream) and Anerdian (disinfectant solution). Key results: It is unclear whether nasal decontamination makes a difference to the rate of SSI in people carrying S aureus bacteria. S aureus SSI was reported in only one trial and the results do not allow us to be certain about differences in infection rates. Some participants in the Anerdian study reported side effects such as itching around the nose, but these were not serious. Mortality was low where reported (one death was directly related to S aureus infection). Quality of the evidence: The two studies we found did not have many participants and the results were inconclusive. The Anerdian study report did not provide information about how the trial was conducted and this makes it difficult to be sure if it was at risk of bias. The Mupirocin study was of better quality and at low risk of bias; but the small number of participants and limited effects affect the quality of the results. Evidence of the potential benefits and harm of using nasal decontamination for the prevention of SSI is currently of low to very low certainty. Larger, better-reported RCTs are needed to assess the clinical effectiveness of this treatment. This plain language summary is up to date as of September 2016.

Plain language summary Nasal decontamination (cleaning the nose with anti-bacterial products) for the prevention of surgical site infection in people carrying S aureus Review question: We reviewed the evidence about whether nasal decontamination (cleaning the nose with anti-bacterial products) is effective and safe for preventing surgical site infection (SSI) in people carrying Staphylococcus aureus (S aureus) bacteria. Background: If bacteria get into a wound site during surgery, this can result in a wound infection commonly called an SSI. SSIs are one of the most common forms of healthcare-associated infections, with around 1 in 20 surgical patients developing an SSI in hospital. This proportion rises when people go home. SSIs can result in delayed wound healing, increased hospital stays, increased use of antibiotics, unnecessary pain and, in extreme cases, death, so their prevention is a key aim for health services. People who are carrying bacteria such as S aureus are especially vulnerable to wound infections. These bacteria can be carried in the nose, and then transferred to a surgical wound. People who are having surgery can have a nasal swab to test for EWMA Journal 

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Publication in The Cochrane Library Issue 6, 2017

Scalpel versus electrosurgery for major abdominal incisions Kittipat Charoenkwan, Zipporah Iheozor-Ejiofor, Kittipan Rerkasem, Elizabeth Matovinovic Citation example: Charoenkwan K, Iheozor-Ejiofor Z, Rerkasem K, Matovinovic E. Scalpel versus electrosurgery for major abdominal incisions. Cochrane Database of Systematic Reviews 2017, Issue 6. Art. No.: CD005987. DOI: 10.1002/14651858. CD005987.pub3. ABSTRACT Background: Scalpels or electrosurgery can be used to make abdominal incisions. The potential benefits of electrosurgery may include reduced blood loss, dry and rapid separation of tissue, and reduced risk of cutting injury to surgeons. Postsurgery risks possibly associated with electrosurgery may include poor wound healing and complications such as surgical site infection. 


Objectives: To assess the effects of electrosurgery compared with scalpel for major abdominal incisions. Search methods: The first version of this review included studies published up to February 2012. In October 2016, for this first update, we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (including In-Process & Other NonIndexed Citations), Ovid Embase, EBSCO CINAHL Plus, and the registry for ongoing trials (www.clinicaltrials.gov). We did not apply date or language restrictions. Selection criteria: Studies considered in this analysis were randomised controlled trials (RCTs) that compared electrosurgery to scalpel for creating abdominal incisions during major open abdominal surgery. Incisions could be any orientation (vertical, oblique, or transverse) and surgical setting (elective or emergency). Electrosurgical incisions were made through major layers of the abdominal wall, including subcutaneous tissue and the musculoaponeurosis (a sheet of connective tissue that attaches muscles), regardless of the technique used to incise the skin and peritoneum. Scalpel incisions were made through major layers of abdominal wall including skin, subcutaneous tissue, and musculoaponeurosis, regardless of the technique used to incise the abdominal peritoneum. Primary outcomes analysed were wound infection, time to wound healing, and wound dehiscence. Secondary outcomes were postoperative pain, wound incision time, wound-related blood loss, and adhesion or scar formation. Data collection and analysis: Two review authors independently carried out study selection, data extraction, and risk of bias assessment. When necessary, we contacted trial authors for missing data. We calculated risk ratios (RR) and 95% confidence intervals (CI) for dichotomous data, and mean differences (MD) and 95% CI for continuous data. Main results: The updated search found seven additional RCTs making a total of 16 included studies (2769 participants). All studies compared electrosurgery to scalpel and were considered in one comparison. Eleven studies, analysing 2178 participants, reported on wound infection. There was no clear difference in wound infections between electrosurgery and scalpel (7.7% for electrosurgery versus 7.4% for scalpel; RR 1.07, 95% CI 0.74 to 1.54; low-certainty evidence downgraded for risk of bias and serious imprecision). None of the included studies reported time to wound healing. It is uncertain whether electrosurgery decreases wound dehiscence compared to scalpel (2.7% for electrosurgery versus 2.4% for scalpel; RR 1.21, 95% CI 0.58 to 2.50; 1064 participants; 6 studies; very low-certainty evidence downgraded for risk of bias and very serious imprecision). There was no clinically important difference in incision time between electrosurgery and scalpel (MD -45.74 seconds, 95% CI -88.41 to -3.07; 325 participants; 4 studies; moderate-certainty evidence downgraded for serious imprecision). There was no clear difference in incision time per wound area between electrosurgery and scalpel (MD -0.58 seconds/cm2, 95% CI -1.26 to 0.09; 282 participants; 3 studies; low-certainty evidence downgraded for very serious imprecision). There was no clinically important difference in mean blood loss 42

between electrosurgery and scalpel (MD -20.10 mL, 95% CI -28.16 to -12.05; 241 participants; 3 studies; moderate-certainty evidence downgraded for serious imprecision). Two studies reported on mean wound-related blood loss per wound area; however, we were unable to pool the studies due to considerable heterogeneity. It was uncertain whether electrosurgery decreased wound-related blood loss per wound area. We could not reach a conclusion on the effects of the two interventions on pain and appearance of scars for various reasons such as small number of studies, insufficient data, the presence of conflicting data, and different measurement methods. Authorsâ&#x20AC;&#x2122; conclusions: The certainty of evidence was moderate to very low due to risk of bias and imprecise results. Low-certainty evidence shows no clear difference in wound infection between the scalpel and electrosurgery. There is a need for more research to determine the relative effectiveness of scalpel compared with electrosurgery for major abdominal incisions.

Plain language summary Scalpel versus electrosurgery for surgical operations on the abdomen Review question: We reviewed the evidence about the effect of using either a scalpel (knife) or electrosurgery in surgical operations on the abdomen. Background: During abdominal surgery, surgeons need to cut through several layers of abdominal wall tissue before reaching the target operation site. To do this, surgeons can use either a sharp-bladed scalpel or an electrosurgical device that burns through tissue using a precise high-frequency current (known as electrosurgery). It is thought that, compared to using a scalpel, electrosurgery may result in less blood loss, more rapid tissue separation, and a lower risk of surgeons cutting themselves. We wanted to find out about the benefits and risks of these two techniques, and to compare them in terms of safety and other measures such as risk of infection and pain. Study characteristics: In October 2016, we searched for randomised controlled trials (RCTs; clinical studies where people are randomly put into one of two or more treatment groups) comparing scalpel-based surgery with electrosurgery for abdominal incisions (cuts). We found seven new trials for this update, allowing us to include a total of 16 RCTs involving 2769 participants. The majority of participants were adults, although one trial included children over the age of 15 years. There were slightly more female participants than male as some trials looked exclusively at caesarean sections (an operation to deliver a baby through a cut made in the abdomen and womb) and gynaecological (female reproductive system) surgery. Key results: There was no clear difference between scalpel and electrosurgery in the number of people whose wounds became infected. It is uncertain whether electrosurgery prevents wound breakdown (a complication that involves the breaking open of the surgical incision along the stitches/staples) following surgery, while the difference in blood loss and time required for incision between electrosurgery and scalpel was not clinically important. There was not enough information available to determine how electrosurgery compared with scalpel-based surgery in relation EWMA Journalâ&#x20AC;&#x201A;

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to time required for wounds to heal, amount of pain during healing, and appearance of scars. More studies need to be conducted before conclusions can be drawn as to whether one method is better for pain after an operation and time to wound healing following abdominal surgery. Quality of the evidence: We judged the certainty of evidence to be moderate to very low for all outcomes. This is because the studies were often small with a low number of events and, in many cases, were not reported in a way that meant we could be sure they had been conducted robustly. The certainty of the evidence means that we cannot make conclusive statements and better quality research is needed to form stronger conclusions.

Data collection and analysis: Two review authors independently performed study selection, ‘Risk of bias’ assessment, and data extraction. Initial disagreements were resolved by discussion, or by including a third review author when necessary. Main results: We found 22 trials that met our inclusion criteria with a total of over 2310 participants (one study did not report number of participants). The included studies mostly had small numbers of participants (from 4 to 317) and relatively short follow-up periods (4 to 24 weeks). At baseline, six trials included only people with ulcers that were clinically infected; one trial included people with both infected and uninfected ulcers; two trials included people with non-infected ulcers; and the remaining 13 studies did not report infection status.

This plain language summary is up to date as of October 2016.

Topical antimicrobial agents for treating foot ulcers in people with diabetes Jo C Dumville, Benjamin A Lipsky, Christopher Hoey, Mario Cruciani, Marta Fiscon, Jun Xia Citation example: Dumville JC, Lipsky BA, Hoey C, Cruciani M, Fiscon M, Xia J. Topical antimicrobial agents for treating foot ulcers in people with diabetes. Cochrane Database of Systematic Reviews 2017, Issue 6. Art. No.: CD011038. DOI: 10.1002/14651858.CD011038.pub2. ABSTRACT Background: People with diabetes are at high risk for developing foot ulcers, which often become infected. These wounds, especially when infected, cause substantial morbidity. Wound treatments should aim to alleviate symptoms, promote healing, and avoid adverse outcomes, especially lower extremity amputation. Topical antimicrobial therapy has been used on diabetic foot ulcers, either as a treatment for clinically infected wounds, or to prevent infection in clinically uninfected wounds. Objectives: To evaluate the effects of treatment with topical antimicrobial agents on: the resolution of signs and symptoms of infection; the healing of infected diabetic foot ulcers; and preventing infection and improving healing in clinically uninfected diabetic foot ulcers. Search methods: We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE, Ovid MEDLINE (InProcess & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in August 2016. We also searched clinical trials registries for ongoing and unpublished studies, and checked reference lists to identify additional studies. We used no restrictions with respect to language, date of publication, or study setting. Selection criteria: We included randomised controlled trials (RCTs) conducted in any setting (inpatient or outpatient) that evaluated topical treatment with any type of solid or liquid (e.g., cream, gel, ointment) antimicrobial agent, including antiseptics, antibiotics, and antimicrobial dressings, in people with diabetes mellitus who were diagnosed with an ulcer or open wound of the foot, whether clinically infected or uninfected. EWMA Journal 

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Included studies employed various topical antimicrobial treatments, including antimicrobial dressings (e.g. silver, iodides), super-oxidised aqueous solutions, zinc hyaluronate, silver sulphadiazine, tretinoin, pexiganan cream, and chloramine. We performed the following five comparisons based on the included studies: Antimicrobial dressings compared with non-antimicrobial dressings: Pooled data from five trials with a total of 945 participants suggest (based on the average treatment effect from a randomeffects model) that more wounds may heal when treated with an antimicrobial dressing than with a non-antimicrobial dressing: risk ratio (RR) 1.28, 95% confidence interval (CI) 1.12 to 1.45. These results correspond to an additional 119 healing events in the antimicrobial-dressing arm per 1000 participants (95% CI 51 to 191 more). We consider this low-certainty evidence (downgraded twice due to risk of bias). The evidence on adverse events or other outcomes was uncertain (very low-certainty evidence, frequently downgraded due to risk of bias and imprecision). Antimicrobial topical treatments (non dressings) compared with non-antimicrobial topical treatments (non dressings):There were four trials with a total of 132 participants in this comparison that contributed variously to the estimates of outcome data. Evidence was generally of low or very low certainty, and the 95% CIs spanned benefit and harm: proportion of wounds healed RR 2.82 (95% CI 0.56 to 14.23; 112 participants; 3 trials; very lowcertainty evidence); achieving resolution of infection RR 1.16 (95% CI 0.54 to 2.51; 40 participants; 1 trial; low-certainty evidence); undergoing surgical resection RR 1.67 (95% CI 0.47 to 5.90; 40 participants; 1 trial; low-certainty evidence); and sustaining an adverse event (no events in either arm; 81 participants; 2 trials; very low-certainty evidence). Comparison of different topical antimicrobial treatments: We included eight studies with a total of 250 participants, but all of the comparisons were different and no data could be appropriately pooled. Reported outcome data were limited and we are uncertain about the relative effects of antimicrobial topical agents for each of our review outcomes for this comparison, that is wound healing, resolution of infection, surgical resection, and adverse events (all very low-certainty evidence). Topical antimicrobials compared with systemic antibiotics : We included four studies with a total of 937 participants. These  43

studies reported no wound-healing data, and the evidence was uncertain for the relative effects on resolution of infection in infected ulcers and surgical resection (very low certainty). On average, there is probably little difference in the risk of adverse events between the compared topical antimicrobial and systemic antibiotics treatments: RR 0.91 (95% CI 0.78 to 1.06; moderate-certainty evidence - downgraded once for inconsistency). Topical antimicrobial agents compared with growth factor: We included one study with 40 participants. The only review-relevant outcome reported was number of ulcers healed, and these data were uncertain (very low-certainty evidence).

Study characteristics: In August 2016 we searched for randomised controlled trials involving the use of any antimicrobial treatment on foot ulcers or other open wounds of the foot in people with diabetes. We found 22 trials involving a total of over 2310 adult participants (one trial did not report the number of participants). Participant numbers in each trial ranged from 4 to 317 and follow-up times during and after treatment ranged from 4 to 24 weeks. Some trials included participants with ulcers that were infected, while other trials included participants with ulcers that were uninfected. The trials compared a variety of different antimicrobial dressings, solutions, gels, creams, or ointments.

Authorsâ&#x20AC;&#x2122; conclusions: The randomised controlled trial data on the effectiveness and safety of topical antimicrobial treatments for diabetic foot ulcers is limited by the availability of relatively few, mostly small, and often poorly designed trials. Based on our systematic review and analysis of the literature, we suggest that: 1) use of an antimicrobial dressing instead of a non-antimicrobial dressing may increase the number of diabetic foot ulcers healed over a medium-term follow-up period (low-certainty evidence); and 2) there is probably little difference in the risk of adverse events related to treatment between systemic antibiotics and topical antimicrobial treatments based on the available studies (moderate-certainty evidence). For each of the other outcomes we examined there were either no reported data or the available data left us uncertain as to whether or not there were any differences between the compared treatments. Given the high, and increasing, frequency of diabetic foot wounds, we encourage investigators to undertake properly designed randomised controlled trials in this area to evaluate the effects of topical antimicrobial treatments for both the prevention and the treatment of infection in these wounds and ultimately the effects on wound healing.

Key results: Many of the trials did not report important data, which means the reliability of the results is uncertain. The results of five trials involving 945 participants suggest that use of some type of antimicrobial dressing may increase the number of ulcers healed in medium-term follow-up (4 to 24 weeks) when compared with a non-antimicrobial dressing (low certainty evidence). Due to limited information, we were unable to assess the effectiveness of treatments in either preventing or resolving wound infection. Four trials involving 937 participants compared systemic antibiotics (given by mouth or via injection, distributed to the whole body by the bloodstream) with antimicrobial treatments applied directly to the wound. These trials did not provide data on healing or infection, but it appeared that there was no difference in the side effects experienced by participants whose ulcers were treated systemically or topically (moderate certainty evidence).

Plain language summary Topical antimicrobial agents (antibacterial products applied directly to wounds) for treating foot ulcers in people with diabetes Review question: We reviewed the evidence about whether or not antimicrobial agents (antibacterial products) can prevent or treat foot infections in people with diabetes when they are applied topically (directly to the affected area). We wanted to find out if antibacterial treatments could help both infected and uninfected wounds to heal, and prevent infection in uninfected wounds. Background: People with diabetes are at high risk of developing foot ulcers. These wounds can cause discomfort and often become infected. Diabetic foot ulcers that do not heal can result in amputation of part or all of the foot or even the lower leg. Antimicrobial agents, such as antiseptics and antibiotics, kill or prevent bacteria from growing, and are sometimes used to treat diabetic foot ulcers. Antimicrobials may be used either to reduce infection or promote healing in infected wounds, or to prevent infection or promote healing in wounds where infection has not been detected. We wanted to find out whether antimicrobial treatments were effective in either of these cases; which treatments were most effective; and if those treated experienced any harmful side effects.


Quality of the evidence: Overall, the certainty of the evidence provided by the trials was too low for us to be certain of the benefits and harm of topical antimicrobial treatments for treating foot ulcers in people with diabetes. More, larger, and betterdesigned randomised controlled trials should be carried out in this area.

Dressings and topical agents for treating Pressure ulcers Maggie J Westby, Jo C Dumville, Marta O Soares, Nikki Stubbs, Gill Norman Citation example: Westby MJ, Dumville JC, Soares MO, Stubbs N, Norman G. Dressings and topical agents for treating pressure ulcers. Cochrane Database of Systematic Reviews 2017, Issue 6. Art. No.: CD011947. DOI: 10.1002/14651858.CD011947. pub2. ABSTRACT Background: Pressure ulcers, also known as bedsores, decubitus ulcers and pressure injuries, are localised areas of injury to the skin or the underlying tissue, or both. Dressings are widely used to treat pressure ulcers and promote healing, and there are many options to choose from including alginate, hydrocolloid and protease-modulating dressings. Topical agents have also been used as alternatives to dressings in order to promote healing. A clear and current overview of all the evidence is required to facilitate decision-making regarding the use of dressings or topiEWMA Journalâ&#x20AC;&#x201A;

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cal agents for the treatment of pressure ulcers. Such a review would ideally help people with pressure ulcers and health professionals assess the best treatment options. This review is a network meta-analysis (NMA) which assesses the probability of complete ulcer healing associated with alternative dressings and topical agents. Objectives: To assess the effects of dressings and topical agents for healing pressure ulcers in any care setting. We aimed to examine this evidence base as a whole, determining probabilities that each treatment is the best, with full assessment of uncertainty and evidence quality. Search methods: In July 2016 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses, guidelines and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting. Selection criteria: Published or unpublished randomised controlled trials (RCTs) comparing the effects of at least one of the following interventions with any other intervention in the treatment of pressure ulcers (Stage 2 or above): any dressing, or any topical agent applied directly to an open pressure ulcer and left in situ. We excluded from this review dressings attached to external devices such as negative pressure wound therapies, skin grafts, growth factor treatments, platelet gels and larval therapy. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessment and data extraction. We conducted network meta-analysis using frequentist mega-regression methods for the efficacy outcome, probability of complete healing. We modelled the relative effectiveness of any two treatments as a function of each treatment relative to the reference treatment (saline gauze). We assumed that treatment effects were similar within dressings classes (e.g. hydrocolloid, foam). We present estimates of effect with their 95% confidence intervals for individual treatments compared with every other, and we report ranking probabilities for each intervention (probability of being the best, second best, etc treatment). We assessed the certainty (quality) of the body of evidence using GRADE for each network comparison and for the network as whole. Main results: We included 51 studies (2947 participants) in this review and carried out NMA in a network of linked interventions for the sole outcome of probability of complete healing. The network included 21 different interventions (13 dressings, 6 topical agents and 2 supplementary linking interventions) and was informed by 39 studies in 2127 participants, of whom 783 had completely healed wounds. We judged the network to be sparse: overall, there were relatively few participants, with few events, both for the number of interventions and the number of mixed treatment contrasts; most studies were small or very small. The consequence of this EWMA Journalâ&#x20AC;&#x201A;

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sparseness is high imprecision in the evidence, and this, coupled with the (mainly) high risk of bias in the studies informing the network, means that we judged the vast majority of the evidence to be of low or very low certainty. We have no confidence in the findings regarding the rank order of interventions in this review (very low-certainty evidence), but we report here a summary of results for some comparisons of interventions compared with saline gauze. We present here only the findings from evidence which we did not consider to be very low certainty, but these reported results should still be interpreted in the context of the very low certainty of the network as a whole. It is not clear whether regimens involving protease-modulating dressings increase the probability of pressure ulcer healing compared with saline gauze (risk ratio (RR) 1.65, 95% confidence interval (CI) 0.92 to 2.94) (moderate-certainty evidence: low risk of bias, downgraded for imprecision). This risk ratio of 1.65 corresponds to an absolute difference of 102 more people healed with protease-modulating dressings per 1000 people treated than with saline gauze alone (95% CI 13 fewer to 302 more). It is unclear whether the following interventions increase the probability of healing compared with saline gauze (low-certainty evidence): collagenase ointment (RR 2.12, 95% CI 1.06 to 4.22); foam dressings (RR 1.52, 95% CI 1.03 to 2.26); basic wound contact dressings (RR 1.30, 95% CI 0.65 to 2.58) and polyvinylpyrrolidone plus zinc oxide (RR 1.31, 95% CI 0.37 to 4.62); the latter two interventions both had confidence intervals consistent with both a clinically important benefit and a clinically important harm, and the former two interventions each had high risk of bias as well as imprecision. Authorsâ&#x20AC;&#x2122; conclusions: A network meta-analysis (NMA) of data from 39 studies (evaluating 21 dressings and topical agents for pressure ulcers) is sparse and the evidence is of low or very low certainty (due mainly to risk of bias and imprecision). Consequently we are unable to determine which dressings or topical agents are the most likely to heal pressure ulcers, and it is generally unclear whether the treatments examined are more effective than saline gauze. More research is needed to determine whether particular dressings or topical agents improve the probability of healing of pressure ulcers. The NMA is uninformative regarding which interventions might best be included in a large trial, and it may be that research is directed towards prevention, leaving clinicians to decide which treatment to use on the basis of wound symptoms, clinical experience, patient preference and cost.

Plain language summary Which dressings or topical agents are the most effective for healing pressure ulcers? Dressings and topical agents for treating pressure ulcers Review question: We reviewed the evidence about the effects of dressings and topical agents (such as ointments, creams and gels) on pressure ulcer healing. There are many different dressings and topical agents available, and we wanted to find out which were the most effective. Background: Pressure ulcers, also known as bedsores, decubitus î&#x201A;Š


ulcers and pressure injuries, are wounds involving the skin and sometimes the tissue that lies underneath. Pressure ulcers can be painful, may become infected and affect people’s quality of life. People at risk of developing pressure ulcers include those with limited mobility - such as older people and people with short-term or long-term medical conditions - and people with spinal cord injuries. In 2004 the total yearly cost of treating pressure ulcers in the UK was estimated as being GBP 1.4 to 2.1 billion, which was equivalent to 4% of the total National Health Service expenditure. Topical agents such as ointments, creams or gels are applied to unhealed pressure ulcers and left in place to treat the wound; they may be covered with a dressing. Some of these treatments have been compared with each other in trials, usually comparing two treatments at a time. We used a method called ‘network meta-analysis’ to bring together all the trial results of different treatments in a reliable way. We hoped that this method, which compares all treatment options, would help us find out which was the best treatment for healing pressure ulcers. Study characteristics: In July 2016 we searched for randomised controlled trials looking at dressings and topical agents for treating pressure ulcers and that gave results for complete wound healing. We found 51 studies involving a total of 2947 people. Thirty-nine of these studies, involving 2127 people, gave results we could bring together in a network meta-analysis comparing 21 different treatments. Most participants in the trials were older people; three of the 39 trials involved participants with spinal cord injuries. Key results: Generally, the studies we found did not have many participants and results were often inconclusive. This problem carried over into the network meta-analysis and made the findings unclear. As a result, it was unclear whether one topical agent or dressing was better than another. Some findings for individual comparisons may be slightly more reliable. Proteasemodulating dressings, foam dressings or collagenase ointment may be better at healing than gauze; but even this evidence is not certain enough to be an adequate guide for treatment choices. Certainty of the evidence: We judged the certainty of the evidence to be very low or low. The next step might be to do more research of better quality to see which dressings or topical agents could best heal pressure ulcers. This plain language summary is up to date as of July 2016.

Publication in The Cochrane Library Issue 7, 2017

Antiseptics for burns Gill Norman, Janice Christie, Zhenmi Liu, Maggie J Westby, Jayne M Jefferies, Thomas Hudson, Jacky Edwards, Devi Prasad Mohapatra, Ibrahim A Hassan, Jo C Dumville Citation example: Norman G, Christie J, Liu Z, Westby MJ, Jefferies JM, Hudson T, Edwards J, Mohapatra DP, Hassan IA, Dumville JC. Antiseptics for burns. Cochrane Database of Sys46

tematic Reviews 2017, Issue 6. Art. No.: CD011821. DOI: 10.1002/14651858.CD011821.pub2. ABSTRACT Background: Burn wounds cause high levels of morbidity and mortality worldwide. People with burns are particularly vulnerable to infections; over 75% of all burn deaths (after initial resuscitation) result from infection. Antiseptics are topical agents that act to prevent growth of micro-organisms. A wide range are used with the intention of preventing infection and promoting healing of burn wounds. Objectives: To assess the effects and safety of antiseptics for the treatment of burns in any care setting. Search methods: In September 2016 we searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid MEDLINE (In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL. We also searched three clinical trials registries and references of included studies and relevant systematic reviews. There were no restrictions based on language, date of publication or study setting. Selection criteria: We included randomised controlled trials (RCTs) that enrolled people with any burn wound and assessed the use of a topical treatment with antiseptic properties. Data collection and analysis: Two review authors independently performed study selection, risk of bias assessment and data extraction. Main results: We included 56 RCTs with 5807 randomised participants. Almost all trials had poorly reported methodology, meaning that it is unclear whether they were at high risk of bias. In many cases the primary review outcomes, wound healing and infection, were not reported, or were reported incompletely. Most trials enrolled people with recent burns, described as second-degree and less than 40% of total body surface area; most participants were adults. Antiseptic agents assessed were: silverbased, honey, Aloe Vera, iodine-based, chlorhexidine or polyhexanide (biguanides), sodium hypochlorite, merbromin, ethacridine lactate, cerium nitrate and Arnebia euchroma. Most studies compared antiseptic with a topical antibiotic, primarily silver sulfadiazine (SSD); others compared antiseptic with a nonantibacterial treatment or another antiseptic. Most evidence was assessed as low or very low certainty, often because of imprecision resulting from few participants, low event rates, or both, often in single studies. Antiseptics versus topical antibiotics: Compared with the topical antibiotic, SSD, there is low certainty evidence that, on average, there is no clear difference in the hazard of healing (chance of healing over time), between silver-based antiseptics and SSD (HR 1.25, 95% CI 0.94 to 1.67; I2 = 0%; 3 studies; 259 participants); silver-based antiseptics may, on average, increase the number of healing events over 21 or 28 days’ follow-up (RR 1.17 95% CI 1.00 to 1.37; I2 = 45%; 5 studies; 408 participants) and may, on average, reduce mean time to healing (difference in means -3.33 days; 95% CI -4.96 to -1.70; I2 = 87%; 10 studies; 979 participants).

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There is moderate certainty evidence that, on average, burns treated with honey are probably more likely to heal over time compared with topical antibiotics (HR 2.45, 95% CI 1.71 to 3.52; I2 = 66%; 5 studies; 140 participants). There is low certainty evidence from single trials that sodium hypochlorite may, on average, slightly reduce mean time to healing compared with SSD (difference in means -2.10 days, 95% CI -3.87 to -0.33, 10 participants (20 burns)) as may merbromin compared with zinc sulfadiazine (difference in means -3.48 days, 95% CI -6.85 to -0.11, 50 relevant participants). Other comparisons with low or very low certainty evidence did not find clear differences between groups. Most comparisons did not report data on infection. Based on the available data we cannot be certain if antiseptic treatments increase or reduce the risk of infection compared with topical antibiotics (very low certainty evidence). Antiseptics versus alternative antiseptics: There may be some reduction in mean time to healing for wounds treated with povidone iodine compared with chlorhexidine (MD -2.21 days, 95% CI 0.34 to 4.08). Other evidence showed no clear differences and is of low or very low certainty. Antiseptics versus non-antibacterial comparators: We found high certainty evidence that treating burns with honey, on average, reduced mean times to healing in comparison with nonantibacterial treatments (difference in means -5.3 days, 95% CI -6.30 to -4.34; I2 = 71%; 4 studies; 1156 participants) but this comparison included some unconventional treatments such as amniotic membrane and potato peel. There is moderate certainty evidence that honey probably also increases the likelihood of wounds healing over time compared to unconventional antibacterial treatments (HR 2.86, 95% C 1.60 to 5.11; I2 = 50%; 2 studies; 154 participants). There is moderate certainty evidence that, on average, burns treated with nanocrystalline silver dressings probably have a slightly shorter mean time to healing than those treated with Vaseline gauze (difference in means -3.49 days, 95% CI -4.46 to -2.52; I2 = 0%; 2 studies, 204 participants), but low certainty evidence that there may be little or no difference in numbers of healing events at 14 days between burns treated with silver xenograft or paraffin gauze (RR 1.13, 95% CI 0.59 to 2.16 1 study; 32 participants). Other comparisons represented low or very low certainty evidence. It is uncertain whether infection rates in burns treated with either silver-based antiseptics or honey differ compared with non-antimicrobial treatments (very low certainty evidence). There is probably no difference in infection rates between an iodine-based treatment compared with moist exposed burn ointment (moderate certainty evidence). It is also uncertain whether infection rates differ for SSD plus cerium nitrate, compared with SSD alone (low certainty evidence). Mortality was low where reported. Most comparisons provided low certainty evidence that there may be little or no difference between many treatments. There may be fewer deaths in groups treated with cerium nitrate plus SSD compared with SSD alone EWMA Journalâ&#x20AC;&#x201A;

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(RR 0.22, 95% CI 0.05 to 0.99; I2 = 0%, 2 studies, 214 participants) (low certainty evidence). Authorsâ&#x20AC;&#x2122; conclusions: It was often uncertain whether antiseptics were associated with any difference in healing, infections, or other outcomes. Where there is moderate or high certainty evidence, decision makers need to consider the applicability of the evidence from the comparison to their patients. Reporting was poor, to the extent that we are not confident that most trials are free from risk of bias.

Plain language summary Antiseptics for Burns Review question: We reviewed the evidence about whether antiseptics are safe and effective for treating burn wounds. Background: Burn wounds cause many injuries and deaths worldwide. People with burn wounds are especially vulnerable to infections. Antiseptics prevent the growth of micro-organisms such as bacteria. They can be applied to burn wounds in dressings or washes, which may help to prevent infection and encourage wound healing. We wanted to find out if antiseptics are more effective than other types of treatment, or whether one antiseptic may be more effective than others, in reducing infection and speeding up healing. Study characteristics: In September 2016 we searched for randomised controlled trials (RCTs) involving antiseptic treatments for burn wounds. We included 56 studies with 5807 participants. Most participants were adults with recent second-degree burns taking up less than 40% of their total body surface area. The antiseptics used included: silver-based, honey, iodine-based, chlorhexidine or polyhexanide (biguanides). Most studies compared antiseptics with a topical antibiotic (applied to the skin). A smaller number of studies compared antiseptics with a non-antibacterial treatment, or with another antiseptic. Key results: The majority of studies compared antiseptic treatments with silver sulfadiazine (SSD), a topical antibiotic used commonly in the treatment of burns. There is low certainty evidence that some antiseptics may speed up average times to healing compared with SSD. There is also moderate certainty evidence that burns treated with honey probably heal more quickly compared with those treated with topical antibiotics. Most other comparisons did not show a clear difference between antiseptics and antibiotics. There is evidence that burns treated with honey heal more quickly (high certainty evidence) and are more likely to heal (moderate certainty evidence) compared with those given a range of non-antibacterial treatments, some of which were unconventional. Burns treated with antiseptics such as nanocrystalline silver or merbromin may heal more quickly on average than those treated with Vaseline gauze or other non-antibacterial treatments (moderate or low certainty evidence). Comparisons of two different antiseptics were limited but average time to healing may be slightly quicker for wounds treated with povidone iodine compared with chlorhexidine (low certainty evidence). Few participants in the studies experienced serious side effects, but this was not always reported. The results do not allow us to î&#x201A;Š


be certain about differences in infection rates. Mortality was low where reported. Quality of the evidence: Most studies were not well reported and this makes it difficult to be sure if they were at risk of bias. In many cases a single (often small) study provides all the evidence for the comparative effects of the different treatments;

and some similar studies provided conflicting results. Where there is moderate or high certainty evidence clinicians will need to consider whether the evidence from the comparison is relevant to their patients. This plain language summary is up to date as of September 2016.


EWMA 2018 9-11 MAY 2018


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 2018 Conference in Krakow will offer networking opportunities between the students from variours 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. Yours sincerely Christian MĂźnter 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 ewma@ewma.org

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L&R – providing solutions for wound care. Our point of interest. We place the well-being of our employees, customers, medical professionals and patients at the heart of everything we do.

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New EWMA President:

EWMAâ&#x20AC;&#x2122;S FOCUS AREAS FOR THE YEARS 2017-2019 By Sue Bale, EWMA President

Over the years, EWMA has developed a strong brand as well as a position to potentially influence wound management practice and education. During the next two years, I would like to further develop this to include integration into everyday clinical practice and the systems that underpin it. This includes supporting the ongoing improvements in wound care for generic clinical staff, as well as specialist clinical staff.

2. To support this goal, I have defined the following focus areas for EWMA during my two years as EWMA president: 1. EWMA will actively support high quality and standardised wound management education across Europe to support the empowerment of the various groups of specialists involved in wound healing. To support this objective EWMA will continue the work to finalise standard curricula for physicians and nurses and support their dissemination and implementation via collaboration with the International Council of Nurses (ICN) and the European Union of Medical Specialists (UEMS). EWMA will also strengthen efforts to develop educational materials for use in wound management education offered by teaching institutions across Europe as well as clinical settings in primary and secondary care.


EWMA will implementation of good wound management practices by increasing the support of front line staff engaged in wound management, and by supporting the establishment of interdisciplinary teams in wound management. To support this, EWMA will use existing systems for improving care and will work to integrate wound management guidelines into these systems. EWMA plans to establish a collaboration with the Institute for Health Care Improvement (IHI) in order to develop care bundle programmes for wound aetiologies that are not yet defined in care bundles. EWMA will continue to support the implementation of guidelines, e.g. through the use of available innovative approaches. We will also continue to use existing channels and networks to raise awareness of current challenges and the benefits of interdisciplinary collaboration with regards to solving some of these challenges.

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3. EWMA will further develop the collaboration between international wound management associations to maximise the impact of the work undertaken by these organisations. This objective builds on the objectives of the previous EWMA presidents. It remains a high priority of EWMA to make full use of the efforts of these organisations. To support this, EWMA will continue to use the annual EWMA Conference as a hub for meetings with partner organisations around the world, with the objective of sharing experiences and defining strategies for addressing common challenges relating to wound management. EWMA will also continue to collaborate with international partner organisations on joint publications or projects addressing common challenges. 4. EWMA will continue to actively promote antimicrobial stewardship (AMS) programmes in wound management with the objective of supporting prudent use of antimicrobials. To support this, EWMA will continue to pursue collaboration with relevant organisations addressing the challenges relating to antimicrobial resistance (AMR), with the objective of implementing best practice conduct by health care professionals engaged in wound management. Together with these organisations, EWMA will work to create awareness about the need for an AMS approach to the AMR related challenges, and will pursue the engagement in relevant national and international activities supporting this. I look forward to working with the EWMA Council and collaborating partners of EWMA to achieve some of these goals during my years as EWMA President. It has so far been a pleasure to take over the baton from Immediate Past President Severin Läuchli, who has done a great job in raising the scientific profile of the EWMA Conferences and extending the network of EWMA.

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FACTS ABOUT SUE BALE EWMA PRESIDENT 2017-2019 Sue Bale was appointed as the R&D Director at ABUHB in June 2013 and previously held the post of Assistant Nurse Director (R&D) for 9 years. She leads research within the organisation, developing strategy and implementing national policy, encouraging participation in research activities, and co-ordinating and overseeing research in the organisation. Sue also holds a chair at the University of South Wales and at Cardiff University. Sue’s expertise falls in the area wound healing research, and she has published widely over the past 34 years. Her research practice and educational interests are wound care, pressure ulcers and incontinence dermatitis. She is the incoming President of the EWMA, and until recently has held the posts of Communication Lead and Editor of the EWMA Journal. In 2004 Sue received recognition for her services to wound healing when the Royal College of Nursing conferred upon her a Fellowship for her ‘Outstanding contribution to nursing research, development and practice of wound care in the UK and internationally’. More recently in 2014, she was invested with an OBE by her Majesty the Queen for ‘Services to nursing and nursing research’. Sue has worked in the Welsh Government for the Chief Nursing Officer for Wales on Clinical Academic Career Pathways, developing policy for the purpose of building research capacity and career paths for nurses and Allied Health Professionals.




9-11 MAY 2018

EWMA 2018 Conference in Krakow, Poland It is a great pleasure to announce the 28th Conference of the European Wound Management Association, EWMA 2018 which will take place in Krakow, Poland, 9-11 May 2018. EWMA 2018 is organised in cooperation with the Polish Wound Management Association (PWMA). The EWMA 2018 Conference gathers the European and international wound management communities with the common goal of improving the care of wound patients. 52

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Krakow: New Frontiers in Wound Management

The EWMA 2018 Conference will focus on the importance of improved and continued education of physicians, nurses, physical therapists and other healthcare professionals engaged in wound management. Wound care technologies are rapidly developing offering new treatment options, which should be used when proven cost-effective and beneficial to the patients. The development further stresses the importance of up-to-date and continued education in an interdisciplinary environment. The technological and educational aspects are two important elements of seeking and expanding the new frontiers in wound management. The EWMA Conference will be held in Poland for the first time. It will take place in the historical city of Krakow. With its long history of intellectual heritage and modern dynamic development, Krakow offers the ideal venue for

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the EWMA 2018 Conference to gather the European and international wound management communities with the common goal of improving the care of wound patients. PROGRAMME EWMA 2018 includes a mixture of new topics, which are important to the European wound community, in addition to topics that have had enormous appeal during previous EWMA conferences. The sessions deal with advancement of education and research in relation to epidemiology, pathology, diagnosis, prevention and management of wounds. ABSTRACT SUBMISSION FOR FREE PAPER AND E-POSTER/PAPER PRESENTATIONS Abstracts for oral presentations and electronic/paper poster presentations can be submitted in the following categories:






Acute Wounds




Basic Science




Devices & Intervention


Diabetic Foot








Health Economics & Outcome


Home Care




Leg Ulcer


Negative Pressure Wound Therapy






Pressure Ulcer




Quality of Life


Wound Assessment


Case Studies (e-posters only)

Professional Communication (e-posters only) n

Submit your abstract and view guidelines and conditions online at www.ewma2018.org Please note that only electronic submissions are accepted. Abstract submission deadline: 1 December 2017 Get inspired and learn more about what an EWMA Scientific Programme may look like by exploring the 2017 programme: www. ewma2017.org/scientific


n n


n n n n n n n n

Opening key session: Krakow: New Frontiers in Wound Management Diabetic foot Leg ulcers and prevention of recurrence - current state of the art Atypical wounds - tools for diagnostics and modern treatment Information technology The burden of wounds / health economics Wound diagnostics and assessment Surgical site infection Advanced therapies Pressure ulcers in a non-acute setting Burns Arterial ulcers

EWMA STREAMS The full-day streams for 2018 are n Burns n TWSDF Guidance/EWMA Diabetic Foot Stream n Infection prevention and control (IPC) including Antimicrobial Stewardship and Surgical Site Infection n Vascularisation WORKSHOPS The workshops are typically held in a smaller setting than key sessions, focus sessions and free-paper sessions. EWMA workshops are interactive and give participants an opportunity to address and elaborate on particular aspects of the themes of the individual sessions. THE WORKSHOPS ARE: n Managing wounds after discharge - Case studies discussion workshop n How to read a paper. Understanding the basics n Debridement n Eczema in leg ulcer patient n Offloading n Pressure Reducing and Relieving Patient Support Surfaces and how to reposition patients effectively to minimise risk FOCUS SESSIONS A focus session is an opportunity to go into depth with a topic. The focus session takes place in a smaller setting and typically presents 1-2 speakers:

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The 2018 focus sessions are: n Isn’t every wound care patient compliant? n Pain in wounds n Atypical wounds - what is your diagnosis? n Lymphoedema and lipoedema n Angiology n The nursing role in a multidisciplinary setting n Biofilm and wounds n Wound care across the life span MEET THE EXPERTS A number of meet-the-experts sessions will take place in the E-poster area and will offer the participants to listen to and discuss with leading experts in an informal setting. GUEST SESSIONS EWMA invites a number of organisations to organise a guest session at EWMA 2018. This serves to increase awareness and also to allow conference participants to learn more about activities related to wound healing and management. It serves to increase scientific cooperation and networking with organisations active in thematic issues related to wound healing and management.


gain new knowledge and best practice about the most recent research and treatment in wound management. 91% of the participants at EWMA 20171 said that they could use the knowledge gained in their daily practice. meet peer researchers and clinicians from all over the world. 97% of the participants at EWMA 20171 networked professionally with the other participants. attend high level key sessions, free paper sessions, hands-on workshops, focus sessions and guest sessions hosted by other medical societies offering new knowledge. 90% of participants stated that the programme offered new knowledge1. meet with suppliers and exchange experiences about wound care products and technology. 94% of participants felt that attending the exhibition was relevant to their work1. 1EWMA 2017 delegate survey.

MORE INFORMATION Stay updated by visiting the Conference website, www. ewma2018.org, where information about registration and the programme is available. You can also get your updates on EWMA’s social media platforms.

We look forward to welcoming you to Krakow!

Stay updated on the latest programme on www.ewma2018.org REGISTRATION Register for the Conference from November 2017 on www.ewma.org/ewma-conference/2018/registration/


Conference dates: 9-11 May 2018 n

WHY ATTEND THE EWMA CONFERENCE? The Conference offers high level scientific presentations, networking activities and an excellent opportunity to exchange knowledge and experiences with international colleagues. Attend EWMA 2018 to:

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Registration opens: November 2017 n

Deadline for abstract submission: 1 December 2017 (23:59 CET) n

Early registration deadline: 15 March 2018




EWMA 2017 Conference in Amsterdam, the Netherlands The 27th Conference of the European Wound Management Association (EWMA) was a great event in many ways! The scientific programme consisted of various key sessions, workshops, lectures, full-day streams and satellite symposia and offered the most recent knowledge to participants. The conference provided an energetic environment in which colleagues in the field of wound management from all over the world came together for more than 1,000 high-level scientific presentations and great networking opportunities. 56

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The 2017 conference was organised in cooperation with the Dutch Knowledge Centre Wound Care (WCS). 4,500 participants took part in the conference, including a large number of international key opinion leaders and senior industry executives. It was encouraging to see the high standards of these presentations and to reflect upon the strong, continued interest in wound healing across Europe. Our heartfelt appreciation goes out to all the speakers, presenters and organisers who actively participated in the sessions. THE CONFERENCE THEME OF EWMA 2017 WAS Change, Opportunities and Challenges - Wound management in changing healthcare systems The theme focused on national healthcare systems in Europe, which are continuously changing, reorganising and adapting in response to changing demographics and budget restrictions. This sets the context which wound healing and wound carers must navigate to provide the best possible treatment for the individual patient. EWMA Journalâ&#x20AC;&#x201A;

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At the same time, technology is rapidly developing, providing new methods and means of treatment and organisation. The conference focused on the changes, opportunities and challenges provided by these on-going processes for wound management across Europe and beyond. THE SESSIONS The conference included many interesting sessions on a variety of wound-related topics. The key sessions covered a variety of topics important to the European wound community in general and dealt with the advancement of education and research in epidemiology, pathology, diagnosis and prevention. Among the sessions were use of oxygen therapies in wound healing; chronic wounds in the fragile, aging patient; diabetic feet; negative pressure wound therapy; healing wounds, saving limbs of arterial ulcers; quality of care and cost effectiveness; prevention and treatment of scars; microbiology of wounds; advanced therapies in wound management; psychological impact of chronic illness or chronic wounds; and surgical site infections across sectors. The conference programme included guest sessions from î&#x201A;Š



many wound care-related organisations, including the Dystrophic Epidermolysis Bullosa Research Association (DEBRA); European Burns Association (EBA); European Council of Enterostomal Therapy (ECET); European Pressure Ulcer Advisory Panel (EPUAP); European Society for Clinical Nutrition and Metabolism (ESPEN); European Society of Plastic, Reconstructive and Aesthetic Surgery (ESPRAS); European Society for Vascular Surgery (ESVS); European Tissue Repair Society (ETRS); International Compression Club (ICC); International Lymphoedema Framework (ILF); Association of Diabetic Foot Surgeons (A-DFS); JA-CHRODIS; V&VN Wound Expertise; World Alliance for Wound & Lymphedema Care (WAWLC); Wound Platform Netherlands; and Wounds Australia. In addition, EWMA was happy to welcome our international partner association from Korea, Korean Wound Management Society (KWMS), which organised a session on Diabetic Foot Ulcer Management and Quality of Life.

E-POSTER PRIZES The e-poster prizes are awarded to e-posters that: n Are visually appealing n Are well laid out in a logical manner n Contain relevant, interesting content n Have clear conclusions

Prizes were awarded to the following four e-posters: n Rose Raizman, EP258, Real-time fluorescence

imaging of bacteria guides treatment selection and timing of dressing changes in patients undergoing negative pressure wound therapy n Liezl Naude, EP133, Intermittent NPWT: Applying

The scientific programme would not have been complete without the many submitted abstracts that contributed to 16 free paper sessions and more than 500 e-posters. EWMA greatly appreciates the interest from all clinicians and researchers who submitted abstracts for the conference!

space technology to wound care n Rowena Jenkins, EP211, Honey represses virulence

and viability in staphylococcus aureus from atopic dermatitis n TorbjĂśrn Lundh, EP232, Zinc-based vs. four

Abstracts presented at the conference as oral or e-poster presentations are available at the EWMA Conference Knowledge website (www.ewma.conference2web.com). 58

component compression

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FIRST TIME INTERNATIONAL PRESENTER AWARD 2017 During the conference, the chairs evaluated the first-time international presenters and selected the following speaker for the First Time International Presenter Award based on the high quality of her presentation, which was especially outstanding:

Anna Zavadakova, Czech Republic Abstract No. OP054: Characteristics of dermal fibro-blasts in novel multifactorial 2D and 3D in vitro models of chronic wound.

Of the many abstracts chosen for presentation at the conference, one was awarded the First-Time International Presenter Prize, and four were awarded e-poster prizes for especially great presentations.

associations for EWMA participants to visit. The industrysponsored symposia were of great value, and the Scientific Committee is grateful for all the industry partners whose cooperation contributed to the success of EWMA 2017.

A NUMBER OF SYMPOSIA WERE ALSO INCLUDED IN THE PROGRAMME: EWMA symposium on the Diabetic Foot was held Thurs-

EWMA 2017 was undoubtedly an enjoyable and informative experience for all the participants. EWMA’s highest priorities are bringing together the European wound healing community and, perhaps most importantly, creating and strengthening links among the national associations that strive to raise the profile of wound management within their respective countries.

day, 4 May and included the International Working Group on the Diabetic Foot (IWGDF) and the International Federation of Podiatrists (FIP-IFP). Webcasts are available at www.ewma.conference2web.com. The Antimicrobial stewardship in wound management. Joint Symposium of BSAC and EWMA addressed the use of antimicrobials. Among the topics were non-antibiotic antimicrobial interventions in wound care, non-antibiotic alternatives in clinical practice and different national approaches to the topic. To strengthen the knowledge base and the educational power of the meeting, EWMA joined forces with the British Society for Antimicrobial Chemotherapy in the symposium held Friday, 5 May. Webcasts are available at www.ewma.conference2web.com. Moreover, the International Conference of the Veterinary Wound Healing Association (VWHA) was held during EWMA 2017. The conference provided a unique platform where scientists and other experts in veterinary and human wound management, as well as public health, could meet. The symposium offered an opportunity to share new knowledge, identify interfaces between veterinary and human wound research and management and create a basis for achieving synergies. The symposium took place Thursday, 4 May.

In addition to the scientific portion of the conference, a get-together event for all the participants took place on the evening of Wednesday, 3 May, at the venue RAI, which provided a great opportunity for informal networking and simply having a great time with other conference attendees. SEE YOU NEXT YEAR! We will build on the success of this conference to make the next one even better. Come join us in Krakow, Poland, for EWMA 2018, 9–11 May. The conference theme will be: Krakow: New Frontiers in Wound Management

The 28th Conference of the European Wound Management Association is being organised in cooperation with the Polish Wound Management Association (PWMA). Thank you for joining us for EWMA 2017 in Amsterdam.

When speaking of the great successes of EWMA 2017, it is important to stress the large contributions of industry.

Join us for the next conference in Krakow! www.ewma2018.org

The exhibition hosted 170 companies, organisations and EWMA Journal 

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New EWMA Council Members

Edward Jude

Samantha Holloway

Alberto Piaggesi

Jan Stryja

Luc Teot

Evelien Touriany

Pedro PancorboHidalgo

Massimo Rivolo

The individual members and the Cooperating Organisations Board elected eight EWMA Council members during the EWMA 2017 Conference in Amsterdam. Edward Jude, United Kingdom [Re-Election] Samantha Holloway, United Kingdom n Alberto Piaggesi, Italy , [Re-Election] n Jan Stryja, Czech Republic, [Re-Election]

Luc Teot, France Evelien Touriany, Belgium n Pedro Pancorbo-Hidalgo, Spain n Massimo Rivolo, Italy





The EWMA Council welcomes all new members of the EWMA Council and looks forward to a fruitful collaboration.

EWMA Honorary positions In May 2017 the EWMA Council elected the following members for positions in the EWMA Executive Committee: Georgina Gethin was elected as the new Honorary Secretary of EWMA. She replaced Alberto Piaggesi. Alberto Piaggesi was elected as the new Scientific Recorder of EWMA. He replaced José Verdu Soriano. Jan Stryja was elected Honorary Treasurer of EWMA. He replaced Luc Gryson. President Elect Sue Bale took over the President role from Severin Läuchli, who will now serve as Immediate Past President for the next two year. In this role he will stay engaged in the EWMA Executive Committee and chair the EWMA Cooperating Organisations Board.

EWMA sincerely thanks all the previous members of the Executive Committee for their great contributions to the continuous development of EWMA.


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Appreciations: Leaving Council Members By Sue Bale, EWMA President

In May 2017, the EWMA Council said goodbye to quite a large contingent of 7 members of whom 5 were elected by the EWMA members and 2 by the Cooperating Organisations. Mark Collier Mark Collier joined the EWMA Council in 2011. The EWMA Council has thus enjoyed Mark’s kind and polite personality for two full terms. This, as well as Mark’s knowledge and engagement in various aspects of wound management, will surely be missed. Mark has a special interest in leg ulcer management. EWMA benefitted from this in connection with the publication of the document “Management of Venous Leg Ulcers – Current Challenges and Best Practice”, to which he contributed as author. Mark also has a great interest in patient perspectives. As a member of the EWMA Patient Panel, he contributed to the development of a patient information section for the EWMA website. Mark Collier has also been an active member of many other EWMA groups and committees, such as the Communication Group, responsible for defining EWMA’s communication strategies, and the Patient Outcome Group, which is a discussion forum for clinicians and industry representatives interested in questions relating to evidence, patient outcomes and regulatory issues in wound management. Finally, Mark has contributed to the work of the Scientific Committee responsible for the EWMA Conference programmes. Mark has been an important link to wound management in the UK, while also supporting the connection to other national wound management societies in Europe, by representing EWMA as a speaker at a number of national meetings across Europe.

Luc Gryson Luc Gryson has been an important player in several EWMA organisations for many years, both as a member of the EWMA Council, i.e. EWMA Treasurer (over two terms), and as a key member and chair of the EWMA Education Committee. Luc Gryson joined the EWMA Council in 2002, and has been a member since, with a short break from 2012 to 2013. As a member and chair of the Education Committee, he has been a key contributor to the development of the University Conference Model (UCM) programme during the annual conference, the first EWMA e-learning course on the basics of wound management, as well as all other activities of the Education Committee. Luc has also been a key contributor to other EWMA working groups such as the EWMA Patient Panel and the Wound Centre Endorsement Group. Finally, Luc played a key role in the EMWA 2011 Conference in Brussels, and has in general been an important link to the national organisations in Belgium and surrounding countries. We hope that Luc will remain engaged in the work of the EWMA Committees in the years to come, and we look forward to the continued collaboration. EWMA Journal 

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Andrea Pokorná The Board of the EWMA Cooperating Organisations elected Andrea Pokorná to the EWMA Council in 2014. Although this has only allowed Andrea to have a 3-year term in the Council, she has been very actively engaged in a number of EWMA activities. Andrea has taken her role as representative of a national Cooperating Organisation very seriously. Her work in the area of actively using the EWMA-initiated “round table concept”, which is engaging national decision-makers in the Czech Republic in wound healing debates, serves as a good example for other Cooperating Organisations. Education is another of Andrea’s principal focus areas . During her time in the EWMA Council, she became a member of the EWMA Education Committee, and she will continue her engagement in the development of EWMA’s post-qualification curricula in wound management for nurses and e-learning modules in basic wound management. Andrea Pokorná has also been a key member of the working group responsible for developing a wound centre endorsement programme for EWMA. Finally, Andrea is engaged in the on-going EPUAP-EWMA Pressure Ulcer Prevention and Advocacy project. As a member of this project group, she established a very valuable connection between the project group and the OECD Health Care Quality Indicators group. We are very pleased that Andrea will continue her engagement in this project into the future.

Salla Seppänen Salla Seppänen leaves the EWMA Council with a very strong and long historical memory after a total of 12 years of engagement. Her first term in Council ran from 2003 to 2009. She left Council for two years after a very successful EWMA Conference in Helsinki in 2009. Salla re-joined Council in 2011. During her 2011-2017 term, she engaged in many different committees and projects, until she assumed the position of President from 2013 to 2015. During her presidency, Salla strongly emphasised the importance of working with the patients perspective and was a leading force in establishing the EWMA Patient Panel. Another of Salla’s hallmarks is the importance of good wound care education, and she has amongst others engaged in the elaboration of the first EWMA e-learning basic wound care course.

José Verdu Soriano After a year-long absence Jose Verdu Soriano, or Pepe, as the Council members know him, was re-elected again to the EWMA Council in 2011. He has now left upon the completion of full 2 x 3 year’s terms. During these 6 years, Pepe has assumed the executive posts of first Treasurer, and thereupon, Scientific Recorder. Based on his extensive knowledge about wound healing in Spain and across Europe, Pepe has actively contributed to core EWMA activities, such as the elaboration of the conference programme, and he was one of the driving forces in the organisation of the 2014 EWMA-GENAUPP conference in Madrid. Pepe has been highly engaged in eHealth technology development in the area of wound management, e.g. by organising conference workshops on the use of wound care apps, thereby contributing to EWMAs work on “eHealth in wound care”.


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Recently, Pepe was one of the EWMA representatives on the joint EPUAP-EWMA Pressure Ulcer Prevention and Patient Safety Advocacy Project. He will continue to represent EWMA in this group until the end of the project period.

Robert Strohal Robert Strohal joined the EWMA Council in 2010 and has been a driving force of many activities during his term. A key accomplishment included the organisation of the EWMA 2012 conference in Vienna. Another of Robert’s great achievements was his initiate on the development of a panEuropean EWMA curriculum for physicians and the subsequent UEMS approval of this. Following this, Robert succeeded in establish in the UEMS Thematic Federation on Wound Healing. This is a great achievement, which may represent a step further towards the implementation of a speciality for physicians engaged in wound healing. Robert also ensured that EWMA could take part in this group as an observer. Robert Strohal took on the role as EWMA UEMS Liaisons Officer for three years, to ensure a good link between EWMA and the UEMS related activities. Following the work the curriculum for physicians, Robert took the initiative to start a working group responsible for developing a post qualification curriculum in wound management for nurses. The objective is to standardise post-qualification education for nurses across Europe. Robert has also initiated other EWMA activities, such as the development of a debridement document (2013) and the development of EWMA e-learning modules on basic wound management, which will soon be available. We will surely miss Robert’s many ideas and energy in driving projects forward.

Hubert Vuagnat The Board of the EWMA Cooperating Organisations elected Hubert Vuagnat to the EWMA Council in 2014-2017. This means that Hubert has only been allowed to serve one 3-year term in Council. He has, however, not hesitated to engage in many EWMA activities during these years. Hubert is currently the chair of the EWMA Wound Centre Endorsement Group, and will continue in this capacity until the group finalises a European programme for wound centre endorsements. Hubert is also engaged in the joint EPUAP-EWMA Pressure Ulcer Prevention and Advocacy Project. It is highly appreciated that he will also continue with this engagement. Finally, it should be mentioned that Hubert is highly engaged in supporting wound care activities in less resourceful parts of the world. In particularly in Cameroon and other Francophone countries in the Western Africa. His role as Secretary General of the World Alliance for Wound and Lymphoedema Care (WAWLC), which has been a close partner of EWMA since 2010, should thus also be mentioned.

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EWMA Journal

Previous Issues

Volume 17, no 1, April 2017 Debridement method optimisation for treatment of deep dermal burns of the forearm and hand Zacharevskij E, Baranauskas G, Varkalys K, Kubilius D, Rimdeika R

Other journals EWMA wishes to facilitate the exchange of information on wound healing in a broad perspective with this section on International Journals. English

CMS MDS 3.0 Section M Skin Conditions in Long-term Care: Pressure Ulcers, Skin Tears, and Moisture-Associated Skin Damage Data Update Elizabeth A. Ayello Relative Temperature Maximum in Wound Infection and Inflammation as Compared with a Control Subject Using Long-Wave Infrared Thermography Arjun Chanmugam, Diane Langemo, Korissa Thomason, et al. Payment Strategies: Have You Read the Revised Surgical Dressing Local Coverage Determination and Article? Kathleen D. Schaum

Lived experiences of life with a leg ulcer - a life in hell Lernevall LSD, Fogh K, Nielsen CB, Dam W, Dreyer PS Illness, Normality, and Self-management: Diabetic Foot Ulcers and the Logic of Choice Andersen SL, Pedersen M, Steffen V

Essential microbiology for wound care Pina E

Volume 16, no 2, October 2016


Efficiency in wound care: The impact of introducing a new foam dressing in community practice Kronert GT, Roth H, Searle RJ

The use of clinical guidelines during the treatment of diabetic footulcers in four Nordic countries Annersten M


Development of an Evidence-Based Global Consensus for Diabetic Van Netten JJ, Bakker K, Apelqvist J, Lipsky BA, Schaper NC, Clinical challenges of differentiating skin tears from pressure ulcers LeBlanc K, Alam T, Langemo D, Baranoski S, Campbell K, Woo K Primary Care Patient Safety (PISA) Research Group Samuriwo R, Evans HP, Carson-Stevens A, Rees P, Hibbert P,

Volume 15, no 2, October 2015 Of youth and Age - What are the Differences regarding skin structure and function ? Kottner J The Development and Benefits of 10 year ́s Experience with an Electronic Monitoring Tool (PUNT) in a UK Hospital Trust. Collier M Preparing student Nurses for the future of Wound Management: Telemedicine in a simulated Learning Environment. Christiansen S, Rethmeier A The Psychological Effect of Malignant fungating Wounds on the Patient. Reynolds H, Gethin G The Pressure Ulcer Guidance (PUG) Tool. Barnard J, Copson D

Helcos, vol. 27, no. 1, 2017 A questionnaire of Pressure Ulcer Prevention Knowledge CPUPP-37: elaboration and content validation Mª Dolores López-Franco; Pedro L. Pancorbo-Hidalgo Current training on chronic wounds in the Nursing degree programs in the Spanish universities Eva Mª Tobajas-Señor; Mª Luisa Lozano-Del Hoyo; Mª José Armalé-Casado Wounds in nursing consultations: what injury creates more work load? Urban observational study Jordi Guinot-Bachero; Erika Herrera-Herzog; Irene IbañezValero History of the compressive therapy: the “Baynton Method” for the treatment of ulcers of the leg Jose Mª Rumbo-Prieto; Luis Arantón-Areosa; Ramón Delgado-Fernández

Volume 16, no 1, April 2016

Challenges faced by healthcare professionals in the provision of compression hosiery to enhance compliance in the prevention of venous leg ulceration Tandler SF Pressure Ulcer Incidence: Do patients retain information? Vowden K, Warner V, Collins J.

Haava, no. 2, 2017 www.shhy.fi Why the wound does not heal? Anna Laine Morbidities affecting to chronic leg ulceration ATeea Salmi Bio-products in local treatment of wounds Tiina Pukki Leg ulcer patient and counselling of living habits Ulla Väänänen

Negative pressure wound therapy in the treatment of acute pyoinflammatory diseases of soft tissues Obolensky VN, Ermolov AA, Rodoman GV

The WAWLC Wound Care Kit for less resourced countries: a key tool for modern adapted wound care Vuagnat H, Comte E

Advances in Skin & Wound Care, vol. 30, no 9, 2017 www.aswcjournal.com


Journal of Tissue Viability, vol. 26, no 2, 2017 www.journaloftissueviability.com Prevalence and incidence density of unavoidable pressure ulcers in elderly patients admitted to medical units Alvisa Palese, Barbara Trevisani, Annamaria Guarnier, et al Biophysical skin properties of grade 1 pressure ulcers and unaffected skin in spinal cord injured and able-bodied persons in the unloaded sacral region Anke Scheel-Sailer, Angela Frotzler, Gabi Mueller, et al Conservative management of distal leg necrosis in lung transplant recipients F. Aigner, M. Husmann, L.C. Huber, et al A survey of patients with surgical wounds healing by secondary intention; an assessment of prevalence, aetiology, duration and management I.C. Chetter, A.V. Oswald, M. Fletcher, et al

The EWMA Journals can be downloaded free of charge from www.ewma.org


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Journal of Wound Care, vol. 26, no 8, 2017 www.journalofwoundcare.com


Sår (Wounds), no. 3 September 2017 www.saar.dk National efforts to reduce the number of pressure ulcers Carina Bååth, Ulrika Källman, Agneta Andersson Malignant ulcer with malodour Susanne Dufva Compression Treatment Hilde Ingebretsen Wound Treatment with fish-skin Ann-Mari Fagerdahl


Wound Repair and Regeneration, vol. 25, no. 4, 2017

Understanding biofilm in practice: a global survey of health professionals T. Swanson, R.D. Wolcott, H. Wallis, E.J. Woodmansey The influence of amniotic membrane extracts on cell growth depends on the part of membrane and childbirth mode selected: a proof-of-concept study Examination of M. Litwiniuk, M. Radowicka, A. Krejner, T. Grzela Cold atmospheric pressure plasma for treatment of chronic wounds: drug or medical device? A. Kramer, B.R. Conway, K. Meissner et al. Concordance and acceptability of electric stimulation therapy: a randomised controlled trial   C. Miller, W. McGuiness, S. Wilson et al.

Volume 25 Number 1 January/February 2017

ISSN 1067-1927



Leczenie Ran vol. 14, no 2, 2017 www.journalofwoundcare.com

Number 1 Pages 1-158 January/February 2017

The latest achievements and future of skin substitutes in chronic wound management Sopata M, Sopata MJ Pedobarography as a diagnostic method for early detection of the risk of overload injuries within the sole mtfwoundcare.org Bitenc-Jasiejko A essure ulcers in the terminally ill patients Miszczuk JP, Blonska-Staniec MK, Rylski R et al. Treatment of fulminant pressure sores using recommendations for pressure sore prophylaxis – case study Bazalinski D, Wolkowicz M, Wiech P et al.

Volume 24

Making wound care better, for everyone.®

Unphosphorylated PTEN Inhibits TGF-β Mediated β-Catenin Translocation


The Wound Healing Society

The European Tissue Repair Society

The Japanese Society for Wound Healing

The Australian Wound Management Association

WRR_C1-C4.indd 1

06/03/17 4:18 PM

German Lithuanian

Lietuvos chirurgija, vol. 16, 2017 www.chirurgija.lt Laying open and curettage - optimal method for pilonidal sinus treatment: review of the literature Makunaite G, Danys D, Strupas K, et al. Incidence of the anterior resection syndrome using low anterior resection score (LARS scale) Dulkas A, Smolskas E, Kilius A, et al. Iatrogenic colonic perforation by colonoscopy outcomes of surgery at a single center Smolskas E, Dulskas A, Kildusiene I, et.al. Hand-assisted laparoscopic surgery for colon and rectal resection: a single-institution experience in 473 patients Kuliesius Z, Dulskas A, Kuliavas J, et.al.


Cadexomer iodine provides superior efficacy against bacterial wound biofilms in vitro and in vivo DJ Fitzgerald, PJ Renick,EC Forrest, et al. Relationship between Opioid Treatment and Rate of Healing in Chronic Wounds. VK Shanmugam, KS Couch, Sean McNish, et al. Biofilm detection by wound blotting can predict slough development in pressure ulcers: a prospective observational study G Nakagami, G Schultz, DJ Gibson, et al. Evidence of invasive and non-invasive treatment modalities for hypertrophic scars: a systematic review M Kafka, V Collins, Lars-Peter Kamolz, et al.

Wund Management, no 4, 2017 When the fish gives the trust – granulation tissue in case of poor circulation Clasen, T.J.; Libich, E.; Feldmann M.

Phlebologie, vol. 5, 2017 www.schattauer.de Postintervention compression therapy - a survey in Germany Mühlberger D et al. Long-term strategies in patients with unprovoked venous thromboembolism Prandoni P. Prophylaxis of complications in venous surgery Romano R et al. EHIT after thermoablation Di Mitri R et al.


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SÅRmagasinet no 2, 2017 www.swenurse.se Patient Education - the family must be a part of the process Jens Fonnesbech Diseases in wax - a forgotten scientific method Adam Bencard Case studies - test of a flexible foam bandage Christa Haxholdt, Daniel Bugera News from NIFS - should Norway have a health party? Arne Langøen

2017 vol 18 no 2



EWMA Publications New publications in 2018



New EWMA document:


Advanced therapies in wound management






Planned publication, spring 2018 The document will introduce the available technologies based on cellular therapies, tissue engineering and tissue substitutes, as well as new treatments based on physical therapies and the potential of sensors and software. The overall aims of the document are to provide health care professionals with a neutral and exhaustive source of information about new treatment options and to provide a point of referral for future discussions and negotiations with health care providers and payers.

New document by EWMA, AAWC & Wounds Australia: Management of surgical wounds and surgical site infections (SSI) Planned publication, autumn 2018 Using published information and data from SSI registries, the document will map the SSI incidence and prevalence as well as high-risk areas. It will also present information on existing modern techniques for the prevention and treatment of SSI and will provide best practice recommendations for SSI management and prevention in hospitals and community care. The document targets health care professionals in primary and secondary care, with a focus on increasing the level of knowledge among nurses working in community care.

For download or more information about the above publications and initiatives, please visit www.ewma.org or contact the EWMA Secretariat: 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 n Please register to become a member here: www.ewma.org


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Mepilex® range Innovation driven. Evidence based. With patients at heart We’re proud that Mepilex® dressings have delivered proven patient and economic value since 2001. And that healthcare professionals like you trust Mepilex as a true solution when facing your daily challenges. We’re always looking for new ways to help you improve your patient and economic outcomes. That’s why Mepilex dressings come in many shapes and forms – with solutions for both treatment and prevention. And did you know the Mepilex range is supported by more than 300 pieces of evidence? Together we will continue to drive the future of treatment and prevention. And, we’re proving it every day.

Mepilex® Border Flex

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Find out more at www.molnlycke.com Mölnlycke Health Care AB, Box 13080, Gamlestadsvägen 3C, SE-402 52 Göteborg, Sweden. Phone +46317223000. The Mölnlycke and Mepilex trademarks, names and logos are registered globally to one or more of the Mölnlycke Health Care Group of Companies. © 2017 Mölnlycke Health Care AB. All rights reserved. HQWC0190

Mepilex® Border Post-Op

Mepilex® XT







Leg ulcers take 200 days on average to heal despite standard treatment.2 The UrgoK2 dual-compression bandage guarantees reliable continuous compression,3 while UrgoStart is a unique Metalloprotease modulator reducing healing time by 100 days on average.1 Act early with UrgoK2 and UrgoStart 1st line for all your leg ulcer patients to reduce healing time.

1. Reality data for UrgoStart: Münter KC, Meaume S, Augustin M, Senet P, Kérihuel J.C. The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings. J Wound Care. 2017 Feb; 26 (Sup2): S4-S15. Erratum in: J Wound Care. 2017 Mar 2; 26(3): 153 2. French Health Insurance Report to the Ministry of Health for 2014. July 2013. 3. Jünger M, et al. Comparison of interface pressures of three compression bandaging systems used on healthy volunteers. J Wound Care. 2009;18(11):474, 476-80. Carefully read patient leaflet before use.


Activities of the Cooperating Organisations during the EWMA 2017 Conference in Amsterdam

By Salla Seppänen, Previous Chair, Cooperating Organisations Board

The collaboration with the Cooperating Organisations continues to be one of the key components of the EWMA conference activities. It is one of the pleasures of each conference to have the opportunity to meet colleagues and exchange knowledge and experiences with the representatives appointed by the national wound healing associations. Pictures from the Cooperating Organisations Board meeting:

Debate session about Education facilitated by Andrea Pokorná.

Council members elected by the Cooperating Organisations Board. From left: Hubert Vuagnat (leaving Council), Pedro PancorboHidalgo (newly elected), Andrea Pokorná (leaving Council), and Massimo Rivolo (newly elected).

EWMA Journal 

COOPERATING ORGANISATIONS BOARD MEETING The 2017 Board meeting gathered 51 representatives of Cooperating Organisations, other partner organisations and EWMA Council members for networking and debate about the key topic, wound care education for professionals.

elected to Council by the Cooperating Organisations Board in 2014. During the meeting, the Board discussed content, requirements, quality and knowledge-base on specialised wound management education across Europe. Multiprofessional teamwork was also highlighted as an important issue. There are many challenges for the development of wound care education, and

The discussion was facilitated by Andrea Pokorná,

2017 vol 18 no 2


EWMA Presenters and chair of the Cooperating Organisations workshop. From left: Maria Charcharidou, Salla Seppänen (Chair), Kirsi Isoherranen, Bengusu Mirasoglu, Barbara den Boogert-Ruimschotel.

thus it is important to learn from good models that can be shared in cooperating board meetings. COOPERATING ORGANISATIONS WORKSHOP The Cooperating Organisations Workshop this year offered the following presentations: n Bengusu Mirasoglu, Wound Management Association of Turkey (WMAT): Chronic Wound Care in Turkey

Kirsi Isoherranen, Finnish Wound Care Society (FWCS): Special Competence in Wound Care n

To ensure that the topics proposed in the abstracts reflect the widest possible field of interest, all Cooperating Organisations were invited to decide by vote, which presentations they would like to see at the conference. I would like to take this opportunity to thank all of the participating and contributing associations and presenters for their important efforts to ensure a successful workshop and Board meeting of the Cooperating Organisations. Last but certainly not least, I encourage all our Cooperating Organisations to consider preparing an abstract for next year’s Workshop and to send representatives to the Board meeting in order to continue to share good practices - successes and challenges in wound care, and thus broaden our horizons!

n Maria Charcharidou, Hellenic Society of Wound Healing: The Impact of the Economic Crisis in Greece in Patients with Chronic Ulcers n Barbara den Boogert-Ruimschotel, Decubitus and Wound Consultants Netherlands (V&VN): Create Superior Wound Care with Simple Steps

Although the session took place early on the Thursday morning, the presentations led to good input and debate amongst the participants. Leading up to the workshop, all Cooperating Organisations were encouraged to submit an abstract about a national wound care-related theme. One of the notable features about the workshop is that it presents the possibility for our Cooperating Organisations to present and debate best practices as well as local initiatives and, thus, draw on the experience of peers across the continent.


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NOVEMBER 13 – 16, 2017 DÜSSELDORF Visit us at Booth 8aD28

SILPURAN® – The biocompatible silicone from Wacker Chemie gives you consistent high quality for efficient manufacturing processes. SILPURAN® provides an optimal wound healing environment and enables atraumatic wound dressing changes. For less pain, less trauma and more quality of life. Wacker Chemie AG, München, Germany, Tel. +49 89 6279-0, Contact: Dr. Manuela Beckmann manuela.beckmann@wacker.com, www.wacker.com/wound-care, www.wacker.com/socialmedia


Launch of the Alliance for Research and Innovation in Wounds Georgina Gethin, PhD, MSc Clinical Research, PG Dip Wound Healing, RGN, School of Nursing and Midwifery NUI Galway, Galway, Ireland Georgina.gethin@ nuigalway.ie Peter Coyne, MSc, BSc, Research Assistant, School of Nursing and Midwifery, NUI Galway, Galway, Ireland Caroline McIntosh, PhD, MSc, BSc Podiatry, Discipline of Podiatric Medicine, NUI Galway, Galway, Ireland Members of ARIW Steering Group.

L-R: Mary Burke WMAI; Prof Caroline McIntosh NUI Galway; Marion Cahill-Collins Saolta University Healthcare Group: Georgina Gethin, EWMA & NUI Galway; Alberto Piaggesi EWMA & University of Pisa, Italy: Mike Trepal New York College of Podiatric Medicine

BACKGROUND On the 31st March 2017, the Alliance for Research and Innovation in Wounds was launched at the 3rd Transatlantic Wound Science and Podiatric Medicine Conference in Galway, Ireland.

Correspondence: ewma@ewma.org Conflicts of interest: None


The Alliance emerged out of the need to bring together the expertise in research, education and clinical practice into one unit that will strive to further develop and expand wound care in Ireland and internationally. Given the significant impact wounds have on the healthcare system, patient morbidity and mortality and the expectation that prevalence will increase, the need for this Alliance is more acute than ever before. Healing rates across a range of chronic wounds remains low at 12 weeks, and the shift in focus from acute to home care settings requires all efforts to continue to develop interventions to improve outcomes.

OBJECTIVES The Alliance will conduct high quality, collaborative, translational and clinical research informed by key stakeholders. It will foster innovation and inspire people to create solutions which will help to enhance graduate education and future employability. The Alliance will aim to be an international leader in the field of wound care, with the hope of informing national and international policy and practice. It is our vision to create economic and social prosperity by turning ideas, innovations and technologies into reality. It will do this through strategic collaborations and enterprise, developing technological solutions to wound prevention and management. î&#x201A;Š

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L-R: Mary Madden, University of Leeds; Amanda Walsh NUI Galway; Caroline McIntosh NUI Galway; Georgina Gethin EWMA & NUI Galway; Tony Iorio New York College of Podiatric Medicine; Wael Tawfick NUI Galway & Saolta University Healthcare Group; Claire MacGilchrist NUI Galway.

THE ALLIANCE WILL BUILD ON FIVE KEY PILLARS New Horizons – emerging technologies and innovation n


Patient orientated


Health systems/services/economic policy


Patient and society impact



The Alliance has already been successful in gaining collaborative research funding and the first two of its PhD students will commence in 2017. Further projects will be announced later in the year. Speaking at the launch, Prof Piaggesi, Scientific Recorder of EWMA and consultant at the Department of Endocrinology and Metabolism of the University of Pisa welcomed this initiative, and recognised how it has the potential to foster interdisciplinary, collaborative, cross-cultural research. Prof Dinneen, national lead for the Diabetes Programme in Ireland and Prof of Diabetic Medicine in NUI Galway reiterated the need for multidisciplinary teams with specific expertise to develop optimal models of community-based diabetes care and understanding of the diabetic foot. ARIW, being a multi-disciplinary initiative, can contribute to this. Also speaking was Prof Mike EWMA Journal 

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Trepal, Prof of Surgery and Vice President for academic Affairs at the New York College of Podiatric Medicine. In his remarks he recognised the physical, social, psychological and economic burden of non‐healing wounds. According to Prof Trepal, the need for the Alliance is very clear and will ultimately contribute to easing the burden on the individual and society. The strength of the Alliance will lie in the sum of its parts, as no one discipline or research group holds all the answers. At the launch Dr. Gethin spoke of the need to hear the voices of members of the public who have wounds and to understand their experiences, so that meaningful interventions can be designed to address their issues. The Alliance is pleased therefore to have a public patient panel and will host its first public event in 2017. Members of the Alliance look forward to building stronger collaborations and making a meaningful impact for future wound care management. FOR FURTHER INFORMATION PLEASE CONTACT US: Join our mailing list through our website at: www.nuigalway.ie/ariw/ Follow us on twitter at: www.twitter.com/ariw_1 We can be contacted through email by: ariw@nuigalway.ie


EWMA Zena Moore1 Professor of Nursing and Head of the School of Nursing & Midwifery, Royal College of Surgeons in Ireland Jose Verdu Soriano1 Senior Lecturer and researcher at the Faculty of Health Sciences. University of Alicante, Spain Andrea Pokorna2 Associate Professor, Department of Nursing, Faculty of Medicine, Masaryk University, Brno Lisette Schoonhoven2 Professor of Nursing, Faculty of Health Sciences, University of Southampton Hubert Vuagnat2 Head of Division of the Department of Rehabilitation and Palliative Care. University Hospitals of Geneva

Joint EPUAP & EWMA Pressure Ulcer (PU) Prevention & Patient Safety Advocacy Project One year ago, EPUAP and EWMA initiated a joint European advocacy project. The overall aim is to establish a joint EPUAP - EWMA engagement in the pressure ulcer prevention and patient safety agendas at the European level as well as at the national level in selected European countries.

1 Chair

of the Joint EPUAP & EWMA Pressure Ulcer Prevention & Patient Safety Advocacy Project 2 Member of the Joint EPUAP & EWMA Pressure Ulcer Prevention & Patient Safety Advocacy Project

presented as part of the joint EPUAP-EWMA session on Thursday 21 September during the EPUAP conference (20-22 September in Belfast, Northern Ireland).

The first year of the project, which was slated to run from 1 July 2016 to 30 June 2018, has now been completed. During the first year, several activities were been initiated, and will be continued during the second year. n

Collaboration and sharing of information with the OECD Health Care Quality Indicators Expert Group (HCQI) http://www.oecd. org/els/health-systems/health-care-qualityindicators.htm by Prof. Lisette Schoonhoven and Prof. Andrea Pokorná, who have had regular meetings with the group and its chair since November 2016. This collaboration is aimed at advocating for a future improved focus on PU as a patient safety related quality indicator.


Publication of two background articles regarding European perspectives on pressure ulcer prevention. Please read the articles on the EWMA website: http://ewma.org/whatwe-do/ewma-projects/we-are-currently-working-on/pu-prevention-and-patient-safetyadvocacy/ or on the EPUAP website: http:// www.epuap.org/projects/#stoppressureulcers

Completed and ongoing activities include amongst other: n

Prof. Zena Moore (representing EPUAP) and Dr Hubert Vuagnat (representing EWMA) met on the 15 June 2017 in Luxemburg with the European Commission (DG-SANTE) policy officer in charge of patient safety, Mr. Matthias Schuppe, and Mr. Gerhard Steffes, the policy officer on health programme and chronic diseases The overall meeting objectives were to call upon the European Commission to look at the patient safety agenda from a wound care perspective, and to discuss how the EPUAPEWMA project group may support the European Commission’s work on patient safety.

Correspondence: ewma@ewma.org Conflicts of interest: None



Elaboration of an epidemiology overview based on existing European prevalence data. The results will be published in a scientific article during the autumn of 2017, and was

During the next few months, the joint working group will engage in meetings with members of the European Parliament for the purpose of

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L – R: Lucia Medori, Instinctif Partners; Gerhard Steffes, DG SANTE C1, Health programme and chronic diseases; Hubert Vuagnat, Division of the Department of Rehabilitation and Palliative Care, University Hospitals of Geneva; Zena Moore, School of Nursing & Midwifery, Royal College of Surgeons in Ireland; Matthias Schuppe, DG SANTE C2, Country knowledge and scientific committees

exploring the opportunities for engaging the European Commission in a pilot project on improvements in the prevention of pressure ulcers.

Support for the project through an unrestricted educational grant has been received from:

The project group includes: n EPUAP representatives: Zena Moore (chair), Lisette Schoonhoven, Jane Nixon and Jan Kottner EWMA representatives: Andrea Pokorná, Jose Verdu Soriano and Hubert Vuagnat n

For further information about the project or how to support or engage in it, please contact: n

EWMA secretariat: Jan Kristensen, jnk@ewma.org

EPUAP secretariat: Adina Markova, adina@codan consulting.com n

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PARTICIPATION IN THE EUROPEAN JOINT ACTION ON ANTIMICROBIAL RESISTANCE AND HEALTHCAREASSOCIATED INFECTIONS The European Commission, policymakers and organisations from 28 countries met at the French Ministry of Health in Paris on 13 September 2017 to launch the European Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections (EU-JAMRAI). The Joint Action EU-JAMRAI aims to bring together the participating EU member states and international organisations, institutes, and universities to contribute to tackling Antimicrobial Resistance (AMR) and Healthcare-Associated Infections (HCAI). It will capitalise on existing initiatives and propose concrete steps to reduce the burden of AMR. AMR is a major public health problem that will cause 10 million deaths worldwide by 2050 unless action is taken. EUJAMRAI is an EU-funded project that will contribute to face this problem, already responsible for an estimated 25,000 deaths per year in the European Union. EWMA has since long been an active advocate for the prudent use of antibiotics. A major step forward in our efforts to combat resistance was the launch of a European Antimicrobial Stewardship Programme for wound management, aiming to reduce inappropriate use of antimicrobials by promoting, facilitating and teaching good antimicrobial practice. EWMA is therefore pleased to join this project and give voice to the wound care community at EU level. The EU-JAMRAI collaboration strives to foster behavioural change at individual and community levels, and tackle this pressing issue within a “One Health” approach, considering the prevention and control of AMR in humans, animals and environment. Vytenis Andriukaitis, European Commissioner for Health and


Joint Action on Antimicrobial Resistance and Healthcare-Associated Infections 13 September 2017 FRENCH MINISTRY OF HEALTH - PARIS

Food Safety, said “The EU-JAMRAI Joint Action is a vital part of the EU ‘One Health’ Action Plan on AMR, launched this June. By ensuring that policies for the control of AMR as well as healthcare-associated infections are adopted and implemented across EU countries in a coordinated way, this ambitious pan-European, multi-stakeholder, project is vital to achieve the goal of making the EU a best practice region. AMR is indeed one of the biggest public health threats we face today, and the most pressing priority spanning both pillars of my portfolio. I would like wish all participants every success with this indispensable joint collaboration.” No less than 44 partners and 38 collaborating stakeholders from all over Europe participate in this JA. Key international organisations such as WHO Europe, OECD, OIE and FAO will take part in this project to fuel the debate with their expertise and ensure consistency with existing initiatives. Additionally, representatives from health professionals, patients and industry will take part in EU-JAMRAI. EU-JAMRAI is funded by the participating partners and the Health Programme of the European Union with a total budget of 6 963 604€, with 4 178 162€ from the EC. For more information on the new EU One Health Action Plan against Antimicrobial Resistance, please visit: http://ec.europa.eu/health/amr/action_eu_en

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MiMedx Amnion Epithelium Basement Membrane Compact Layer Fibroblast Layer Chorion Fibroblast Layer Basement Membrane

MiMedx is a leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare. To date, over 40 clinical and scientific papers have been published in peer-reviewed journals on our PURION® Processed amniotic membrane allografts in the treatment of acute and chronic wounds. The company has over 45 issued patents and more than 90 patents pending. PURION Processed allografts are clinically effective and more than 1,000,000 allografts have been distributed to date with no reported adverse reactions attributed to our products. MiMedx offers the largest portfolio of placental tissue allografts to meet the needs of physicians and patients, including EpiFix®, AmnioFix®, EpiCord®, AmnioCord®, and AmnioFill®. EpiFix is the leading skin substitute utilized in the United States and contains growth factors, cytokines and chemokines that help modulate inflammation, enhance healing and reduce scar tissue formation. PURION Process Minimally manipulated to retain natural collagens and growth factors. Provides an effective allograft with excellent handling

characteristics and a 5 year shelf life stored at ambient conditions. U.S. Pharmacopeia Monograph MiMedx dHACM is the first amnion/chorion dehydrated membrane to meet the requirements of the USP (United States Pharmacopeial) monograph for amniotic membrane allografts.1 The publication of the monograph has clearly established another standard by which MiMedx dHACM allografts are unmatched in the industry. Safety PURION® Processed allografts are terminally sterilized resulting in a safety factor at least 1,000 times higher than the typical drug or tissue products only processed aseptically. More than 1,000,000 allografts have been distributed to date with no reported adverse reactions attributed to our products.† Clinical & Scientific Publications • 40+ clinical & scientific publications • 90%+ healing rates in DFUs 2-6 • 160+ posters presented

REFERENCES: 1. 2017 U.S. Pharmacopeia – National Formulary Monograph (USP40-NF35). Tissue Human Amnion Chorion Membrane Dehydrated; p. 6486-87. 2. Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016 Apr;13(2):272-82. 3. Zelen CM, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015 Dec;12(6):724-32. 4. Driver VR, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. 5. Zelen CM, Serena TE, Fetterolf DE. Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study. Wound Medicine. 2014 Feb;4:1-4. 6. Zelen CM, Serena TE, Snyder RJ. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr;11(2):122-8 † As of August 15, 2017


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From the pristine waters of the North Atlantic:

Kerecis™ Omega3 Wound Reconstructive tissue graft for tissue repair. Icelandic, Omega3-rich fish skin.

The Kerecis™ technology is a unique, patented, acellular, Omega3-rich, intact fish skin used to graft wounds and regenerate damaged human tissue. Benefits n Full-thickness n Omega3 n Early n Easy

skin similar to human skin


surface area reduction

application, easy to handle

n Evidence-based n Intact,

acellular skin

n Effective n No


antimicrobial barrier

known cultural or religious conflicts

n Room n Cost

temperature storage and long shelf life


Fish skin and human skin are surprisingly similar, and Kerecis Omega3 is more similar to human skin than any other skin substitute. Because of the low disease-transmission risk, fish skin is gently processed and thereby retains its natural structure, proteins, fats (including Omega3) and other skin elements. This is one reason why fish skin EWMA Journal 

2017 vol 18 no 2

favorably compared with mammalian skin substitutes in a randomized controlled trial (N=162). Chronic wounds are stuck in an inflammatory stage and fail to progress through the normal stages of healing. Kerecis™ Omega3 Wound effectively salvages the wound from the inflammation stage and allows normal healing to occur. Cells and stem cells migrate into the Kerecis material, where they create new tissue to seal the wound. The Origin of the Product: Clean and Environmentally Sustainable The Kerecis™ Omega3 fish skin is sourced from the pristine waters of North Iceland close to the Arctic Circle. The fish skin is processed immediately after harvesting, when a natural mucus on the fish skin protects it from bacterial growth and eliminates the need for a stabilization step in manufacturing. Processing of human tissues and other mammalian tissues calls for extensive use of penicillin and other antibiotics to reduce bioburden and prevent bacterial growth during processing. Kerecis is committed to the responsible use of natural resources. All of our raw materials are sustainably sourced and harvested, and no chemicals that are harmful to the environment are used in the manufacturing process. All power used during manufacturing is renewable (geothermal and hydro). A list of our distributors around the world is available at www.kerecis.com Email: info@kerecis.com 79


Frontier Medical Group is a market leading healthcare group engaged in the manufacture and supply of pressure ulcer prevention, infection control and harm reduction products. Established for over 50 years, we have provided products to healthcare providers in the UK and internationally from our head office and manufacturing site in South Wales, United Kingdom.

Frontier Medical Group are committed to developing and providing innovative products to support the prevention and management of pressure damage supported by the Repose, Toto and Ultracore ranges. Our Repose range of pressure redistribution products were developed in conjunction with the University Hospital of Wales in 1997. Clinically proven, the innovative concept uses immersion and envelopment to support patients, gently but effectively, who are at risk of developing pressure damage or those with existing pressure ulcers. With a patented smart valve to ensure the products are never over inflated, the range of seating, foot care and support surface solutions are also portable, air-filled and durable. Repose technology is also at the heart of the Ultracore range of static, hybrid mattresses offering silent, unobtrusive comfort.

To keep patients moving, the Toto lateral turning system helps clinicians and carers in the regular turning of patients, preventing pressure damage when manual intervention is not possible or desirable. Manual turning of patients can be intrusive, particularly during the night and frequently resulting in disturbed sleep. For clinicians and carers, this can also be a significant use of resources. Comprising a lifting and turning platform complete with a control unit, the Toto system gently moves patients at regular intervals to assist with patient turning and pressure injury prevention plans. To support clinicians worldwide, we have an international network of distributors supported by the Frontier Head Office in Wales with a dedicated sales and marketing team in the UK. Frontier Medical, Pioneering simplicity.


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EWMA Upcoming activities EWMA has defined the following focus topics for the period 2017-2019:

WOUNDS ACROSS THE LIFE SPAN Not all wounds are the same and not all people respond to wounds in a similar manner. And so it is with wounds across the lifespan. EWMA has therefore decided to focus on the management of individuals with wounds in the two extremities of life: n

Neonatal and paediatric wound care is under-represented in the wound care literature and within the current EWMA activities. Yet, this population poses significant challenges in the types of wounds and the bodily response to healing. Despite this, neonatal and paediatric wound care dressing and practices are often based on extrapolation of adult-based guidelines while they should be applied considering specific skin features and structures.


At the other end of the life span we have an increasing ageing population with altogether complex and different wound aetiologies of a more chronic nature, and a different response to healing. Given the generally aging population, there is an increasing need to understand how age influences wound healing and the different wound aetiologies that can be encountered at different life stages.

EWMA plans to publish two documents to cover these topics: One document on neonatal/ paediatric wound management, and one on the management of geriatric wound patients. These documents will provide health care professionals with a resource that outlines the pathophysiology and recommended organisation of wound healing as it applies to these specific age groups. The author group will be chaired by EWMA Council members Georgina Gethin and Sebastian Probst. Hubert Vuagnat and Valentina Vanzi will join the author group. Additional members of the group with relevant knowledge and experience about pediatric and geriatric wound management will be appointed.

ATYPICAL WOUNDS This document will provide an overview of recent knowledge and evidence about atypical wounds, which in general terms are wounds which cannot be placed in the main wound categories. Amongst others they present a broad spectrum of conditions caused by inflammation, infection, malignancy, chronic illness or genetic disorder. The prevalence of atypical wounds can be as high as 10% of all wounds, and they constitute a significant proportion of wound patients especially in dermatological departments, and their considerable diagnostic delay and prolonged healing time has an enormous impact on patient Quality of Life. The objectives of the document include to provide an overview on the wounds typically considered atypical, present the diagnostic criteria, comorbidities and diagnostic tools for these wounds as well as the available best documented treatment options including immunosuppression and other modern/advanced wound healing therapies (e.g. NPWT). Further, the document will define the challenges and recommendations related to organisation of treatment and care and health economy. The author group responsible for this document will be chaired by EWMA Council member Dr Kirsi Isoherranen, dermatologist and dermato-surgeon. The group will include members with different professional backgrounds relevant to achieve the objectives of the project. EWMA Journalâ&#x20AC;&#x201A;

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Recognition of wound care centres in Switzerland Quality management based on patient focus and process-oriented thinking CONTINUOUS IMPROVEMENT Authors: Wüthrich, J. Kohler, E. Mayer, D. Von Siebenthal D. Signer, M.







More information: www.safw.ch







Figure 1


Risk reduction, coverage

One of the focuses of the Swiss Association for Woundcare (SAfW-D-CH) with regard to recognition of wound care centres is quality of care and patient safety, and improving effectiveness and efficiency through an integrated organisational structure. Divided into three key factors for successful service marketing, the SAfW-D-CH catalogue of recognition requirements is presented; the documentation relevant for testing and the benefits of recognition are indicated. The objective of achieving a harmonised standard for wound care both within and outside of hospitals is possible through forward-looking collaboration between various professions.

Quality of care and patient safety are integral to every wound care centre.

Reasons in favour of recognition of wound care centres A harmonised organisational strategy increases efficiency and effectiveness. A process-oriented approach turns expectations into operational performance (Fig. 1).

Legal provisions

EWMA Cooperating Organisation


While recognition of wound care centres is not regulated by law in Switzerland, the Swiss Health Care Insurance Act (KVG) does set quality standards. The SAfW-D-CH recognition process creates and maintains appropriate standards.

Economic necessity Expansion of services while reducing budgets is on everyone’s minds. Donabedian’s 1968 definition of quality1 makes it clear that quality management has been following precisely this objective for quite some time now. “Quality is the degree to which success can be achieved given the ideal circumstances and justifiable costs. (Technical management, interpersonal relationships, access to and continuity of care)”

SAfW-D-CH recognition of wound care centres in Switzerland A wound care centre recognised by the Swiss Association for Woundcare (SAfW-D-CH) is an institution defined by a network. The core competence is interdisciplinary collaboration. At present, 16 centres have valid SAfW-D-CH recognition. Since it was launched in September 2009, a total of 24 wound care centres in the German and Italian part of Switzerland have been recognised, but some of them did not apply for subsequent recognition. Following a merger, five centres are working on a common wound care concept so that they can rejoin the network in 2018. The catalogue of requirements2 provides a wound care

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HR POLICY/QUALIFICATIONS n Management: Has an adequately trained manager n Nursing care: At least one employee who has completed wound-specific training (WEX, ZWM,

or an equivalent course)

n When opening a wound care centre, training must have been completed within the last three years,

or proof must be provided of undertaking wound-specific activities since receiving certification

n Medical management: A doctor with experience treating chronic wounds (with advanced training

certification) must be available at all times, but that doctor does not have to be physically present at all times

n Interdisciplinary/cross-occupational: In addition to the departments directly involved in diagnostic

and therapeutic processes, contacts from other areas including orthopaedics, podiatry physiotherapy, lymphatic therapy, nutritional counselling, diabetes counselling and others

PROCESS POLICY n Provision of the service is guaranteed in that the wound care centre is contactable around the clock

or has an automated system for notifying a contactable person

n Catalogue of measures for initial consultations: medical history/wound history, lab results as well

as angiological, neurological, endocrinological, infection-related and other diagnostics

n A facility can always be accessed for additional in-patient treatment n Attention is paid to interaction quality by in turn placing great importance on communication between

the specialists in the network. Treatment gaps and duplicate treatments are reduced and unnecessary treatment durations and costs are avoided

n The quality of the results is continually updated by continuing education and training for wound

specialists (at least 25 hours per year)

EQUIPMENT POLICY n The treatment rooms are equipped with treatment beds, privacy screens, bed protection, waste disposal,

lighting, ventilation and wash basins with running water

n Medical supply trolleys with the required materials for hygienic, non-touch wound treatment n A work station for administrative work is available

centre with a professional and organisational structure, and includes the following issues regarding service quality (Fig. 2)

n Treatment reports n Standardised forms for documenting evaluations

To obtain recognition, a wound care centreâ&#x20AC;&#x2122;s standards must be inspected by the SAfW-D-CH. To this end the following documentation needs to be submitted: n Wound care concept (not older than one year) n Organisational manual

n Interdisciplinary measures plan

Recognised wound care centres are listed on the SAfW-D-CH website (safw.ch). Renewal of the recognition requires the current documentation to be submitted every three years. The SAfW-D-CH may carry out spot checks at any time. Once recognised, wound care centres are required to keep records of

n Standardised wound and photo documentation

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all wounds treated in the national data register. 8,911 cases have been handled since 2011. The SAfW-D-CH recognition stands for a harmonised quality standard both within and outside of hospitals. As part of external wound care, referral to medical and paramedical specialists is primarily via general practitioners. At the same time, it is desirable for the external wound care centres to have a close network so that they can provide general practitioners with advice or recommendations as necessary. In this regard, the SAfW-D-CH is doing pioneering work and, in addition to internal hospital centres, has also recognised three external teams (after adequate development of appropriate criteria). Swiss wound care has its finger on the pulse4: “The increased collaboration between the various health care professions is pioneering5”.

REFERENCES: (1) Glaser A. Qualitätssicherung Gesundheitswesen Merten International. In: ZWM®cert Modul 6 der Akademie ZWM Kammerlander WFI 2007, Dezember, Frankfurt (2) Signer M, Bindschedler P, Jordan X, Kohler E, Schlüer AB, Wüthrich J. Schweizerische Gesellschaft für Wundbehandlung SAfW [Internet]. Catalogue of requirements for recognition of outpatient wounds as part of a wound care centre. United Visions GmbH: SAfW [2017 Aug 17; 2017 Jul 20].

(3) Salzmann Y. Der Weg von den 4P zu den 7. In Anlehnung an: Zollondz HD: Marketing Mix 2005, p. 107. Marketing.ch: [2017; 2017 Feb 15] (4) Atzeni G. Schmitz C, Berchtold P. Die Praxis gelingender Interprofessioneller Zusammenarbeit. In: Swiss Academies Reports 2017 Vol.12, No2. KARGO Kommunikation GmbH: SAMW Bern [2017; 20 July 2017 Jul 20] (5) Citrini-Hunger A, Feusi E. Herausfordernde Berufspraxis meistern und zusammen arbeiten. In kommunikation.gesundheit@newsletter.zhaw.ch 2016 Dez 16. Onlinekom: ZHAW [2017; 20 July 2017]

Submit your paper to EWMA Journal Volume 17 16 Number 1 2016 April 2016

Volume 16 15 Number 2 2015 October 2015

Published Published by by European Wound Wound Management Management Association

Published Published by by European Wound Wound Management Management Association

on the road to better



New Author Guidelines for scientific papers available at: www.ewma.org

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Sebastian Probst, Editor Sue Bale, Editor in Chief Vickie R Driver

Georgina Gethin Salla Seppänen Andrea Pokorná

www.ewma.org 84

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This is how life feels to people with EB. Their skin is as fragile as a butterflyâ&#x20AC;&#x2122;s wing. They have Epidermolysis Bullosa, a painful and currently incurable skin blistering condition. www.debra-international.org

3rd Nordic Diabetic Foot Symposium 2018 Helsinki, Finland 6 - 7 November 2018

All photos c by Helsinki Marketing





Polish Wound Management Association

PWMA Polish Wound Management Association

Maciej Sopata President, Polish Wound Management Association More information: www.ptlr.org/pl


EWMA 2018 9-11 MAY 2018

EWMA 2018 Conference is organised in cooperation with PWMA.

PWMA focuses in particular on the issues of healing and care for healing wounds such as leg ulcers (varicose veins and arteries) and bed sores The Polish Wound Management Association (PWMA) was established in 2004 and is an association whose aim is to change the current methods and standards for the management of patients suffering from various types of acute and recurrent wounds. In its activities, PWMA focuses in particular on the issues of healing and care for healing wounds such as leg ulcers (varicose veins and arteries) and bed sores. In Poland, these two diseases cause about half a million patients every year. In most cases treatment is not conducted in a modern way, which not only prolongs its time and often leads to worsening of the condition of the wound, but also generates higher financial outlay of treatment than modern therapies. To change this, PWMAâ&#x20AC;&#x2122;s key activity is broad education of the medical community. In this respect, the main goal of PWMA is to cooperate with other medical societies in the development and implementation of training programmes for physicians and nurses and the introduction of clinical practice standards of excellence in Western European countries. PWMA carries out scientific and educational activities in the treatment of wounds of various aetiologies, hence the presence in our ranks of many general and paediatric surgeons, wound healing specialists, vascular surgeons, dermatologists, nurses of various specialties, family physicians, etc. PWMA is an interdisciplinary organisation open to all concerned with the problem of wound healing. The key statutory goals of the PWMA include: n

EWMA Cooperating Organisation


Working towards raising the scientific and clinical level of modern methods of treating wounds of different aetiologies in Poland and making progress in this area to Polish doctors of various specialties and nurses.

n Organising a forum for discussion and exchange of experience in an interdisciplinary group of woundcare specialists and medical

practitioners in the field of modern wound healing. n Action to increase the availability of modern wound care in Poland.

Action for the implementation of modern standards of wound healing of different aetiologies by physicians and nurses. n

n Action for the introduction of training in wound healing in the training programmes for doctors and nurses in both graduate and postgraduate education programmes. n

Education and educational activities in the field of modern wound healing.In the course of the current activities, PWMA has organised three scientific and training conferences with the participation of guests from abroad.

The PWMA Board actively participates in the organisation and patronises many training and development programmes for physicians and nurses, ensuring a high level of care, and popularising the knowledge of chronic wound healing during various meetings and symposia. A number of monographs and guidelines have been published so far, significantly expanding knowledge in Poland about the treatment and care of chronic wounds. In recent years, the first Polish study on the effectiveness of venous leg ulcer treatment (Bydgoszcz), as well as epidemiological studies under the auspices of the European Society for the Treatment of Rheumatoid Arthritis (Opole, Bydgoszcz), were also undertaken. Members of the Management Board of PWMA together with the Ministry of Health has worked out a common consensus on the division of major dressings groups for the treatment of chronic wounds. Currently, as a result of several years of effort, we are looking forward to the approval of the project and extending the refund list with specialised dressings.

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FIP-IFP The International Federation of Podiatrists

Matthew G. Garoufalis, DPM, FASPS, FACFAOM, CWS, FFPM RCPS (Glasg) President, International Federation of Podiatrists, FIP-IFP More information: www.fip-ifp.org

EWMA International Partner Organisation

EWMA Journal 

FIP-IFP NEWS The value of podiatry The International Federation of Podiatrists (FIP/IFP) has entered into a partnership with EWMA this past year. It has increased awareness of how podiatrists are involved in the care and treatment of the diabetic foot. In Amsterdam, FIP/IFP was provided with a lecture tract where we demonstrated the scope of podiatric care across Europe in terms of both wound care and surgical care of the diabetic patient. The inter-professional care of the patient with a diabetic foot ulcer was discussed and examples were given of differences in podiatric care across Europe. An affiliation with D-Foot International was also presented. This affiliation will allow for a greater awareness of how the podiatrist can become involved in the care and treatment of the diabetic foot. The value of podiatry was also presented. When a podiatrist is involved in the care of the patient with a diabetic foot ulcer, there is direct correlation to a decreased rate of infection, hospitalisation, and amputation. This also results in a significant cost saving to both the patient and the health care system. This can also be shown to increase the quality of life of those patients affected as well as their families. The International Federation of Podiatrists looks forward to a continuing and educational future with EWMA.

2017 vol 18 no 2

21 - 23 June 2018 · Rheine · Germany

The 4th International course on the

Neuropathic Osteoarthropathic Foot (Charcot) The three day theoretical & practical course gives participants a thorough view of the different aspects of the diagnosis, treatment and management of the Charcot Foot. The course will consist of practical sessions in small groups, where the main focus will be on training the diagnostic and treatment skills necessary for the interdisciplinary treatment of Charcot patients. In addition, state of the art lectures and presentations will be given by international specialists in the field.

Venue Practical:

Mathias-Spital Interdisciplinary Diabetic Foot Centre Rheine, Germany


Mathias-Spital University of Applied Sciences Rheine, Germany


Hands-on workshops/training in clinic combined with lectures





AAWC NEWS AAWC It’s a pleasure to update EWMA members Association for on the activities of the AAWC the Advancement of Wound Care

I welcome the opportunity to provide an update to EWMA journal readers. The Association for the Advancement of Wound Care (AAWC) is the leading interdisciplinary organisation for wound healing in the United States, and we have had tremendous success over the last several years. Our Annual Meeting in 2017 in San Diego was a very successful meeting. It’s an opportunity to evaluate our projects and assess next steps.

Greg Bohn, MD, FACS, ABPM/ UHM, CWSP, FACHM President, Association for the Advancement of Wound Care More information: www.aawconline.org 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.

Our consolidated guidelines task force completed the venous ulcer guideline. This is the culmination of many volunteer hours of work. The document brings together the best evidence available into one document. By providing the best evidence in one document, our hope is that the guideline can be a reference for our colleagues who are looking for the basis of evidence-based practice. Our Clinical Endpoints study WEP-CEP (Wound-care Experts/FDA – Clinical Endpoints Project (WEFCEP)) just recently had the opportunity to meet with the FDA and present out findings in an educational meeting. It was very well received and the FDA asked that we return to update them again as we report on our findings. The first of three papers describing the study will be published soon. AAWC has embarked on hosting a Summit meeting to update and define the State of Pressure Related Wounding. Plans to bring together leading experts and researchers in the field, giving them the opportunity to present their work and update our knowledge regarding the evaluation, treatment and prevention of pressure-related wounding may bring new light to our understanding. As part of this process, we invite any interested person or organisation to attend and contribute to redefining a current model of pathophysiology that takes into consideration recent developments and research that look to understand pressure and its effects on tissue and pathology. The meeting will truly be a Summit Meeting with contributions from stakeholders and organisations with a vested interest in Defining Pressure that make sense to help patients with pressure-related wounds. As a multidisciplinary organisation, we have learned to be inclusive. If you have an idea that would improve what we can offer members, let us know. Your contributions can make a difference. We invite our international friends to join AAWC and our mission to advance the care of people with and at risk for wounds. Please contact any board member or the office at any time; we are always happy to hear your suggestions. Visit our website to learn more about getting involved: http://aawconline.org. Wishing you all the best. Greg Bohn, President, AAWC

EWMA International Partner Organisation


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• Official organ of the German and Swiss Phlebological Society • Free online access to all articles, even to the online archive dating back to 1998! • All publications available in English too, since 2013! • Always stay up to date by signing up for the Electronic Table of Contents (eTOC) at: www.schattauer.de/etoc-EN.html Phlebologie 6 issues per volume ISSN 0939-978X www.phlebologieonline.de

• Submit your next paper to Phlebologie! Reach your audience without restrictions – free download of all articles at www.phlebologieonline.de

Founded in 1972, the journal Phlebologie has served for decades as the leading European peer-reviewed journal advancing knowledge in the field of venous disorders. As the official journal of the German and Swiss Societies of Phlebology it is the field’s most important scientific journal in the German speaking countries to date. The journal publishes original and review articles on all aspects of the field as well as theme-oriented issues on new and emerging diagnostic procedures, therapies, or preventative medicine. Since 2013, all scientific articles are translated into English and published online as articles freely accessible to everyone. All scientific manuscripts are strictly peer-reviewed in a blinded fashion by international renowned experts. The journal strictly follows the ethical guidelines and recommendations provided by the International Committee of Medical Journal Editors and related organizations. Free print copy (articles mainly in German) available on request.



ALLIANCE NEWS Alliance of Wound Care Stakeholders

Marcia Nusgart R.Ph.Executive Director, Alliance of Wound Care Stakeholders More information: www.woundcarestakeholders.org About the Alliance: The Alliance is an association of physician and clinical organisations focused on advocating quality wound care, access to products and services for patients with wounds and the providers who treat them. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites wound care organisations and experts to advocate on public policy issues that may create barriers to patient access to treatment or care.

Wound Care and Health Policy: U.S. Advocacy Update from the Alliance of Wound Care Stakeholders The Alliance of Wound Care Stakeholders (“Alliance”) marks our 15th anniversary as an association of physician specialty societies, clinical and non-clinical associations and business entities focused on promoting quality care and access to products and services for patients with wounds and the providers who treat them. Through advocacy and educational outreach in the regulatory, legislative, and public arenas, the Alliance unites leading wound care experts to advocate with a unified voice on policy issues that may create barriers to patient access to treatments or care. The Alliance leverages the collective power of members to ensure that wound care has a strong voice and a seat at the regulatory table – e.g., with Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) – when policies are being developed and decisions are made. We focus on reimbursement (coding, coverage and payment) issues for wound care products and procedures, as well as on quality measures, research and regulatory issues. With the shifts in the U.S. healthcare landscape under a new Presidential administration and the implementation of Medicare payment reform/value-based care, having a united voice to represent a wound care perspective in policies and regulations has never been more important. Marcia Nusgart, Executive Director of the Alliance, spoke about the changing U.S. healthcare climate and what it means for wound care, at the 2017 EWMA meeting in Amsterdam. (Her talk is downloadable on the EWMA site.) We continue to educate members, stakeholders, regulators/legislators – and colleagues at EWMA – about the impacts evolving policies have on wound care. Now representing 20+ clinical societies, the Alliance makes its collective voice heard on a range of important issues including: cellular and/ or tissue-based products for wounds, negative pressure wound therapy, surgical dressings, antimicrobial wound care dressings, pneumatic compression devices, hyperbaric oxygen therapy and more.

Our advocacy focus in 2017 has included: n Working with CMS to ensure that wound care is discussed and included in payment reform and alternative payment models; ensuring Alliance membership is educated about the practical impact of payment reform. n Commenting on Medicare coverage, coding and payment policies that affect wound care, ensuring that impacts to wound patients and practitioners are voiced. n Educating regulators, legislators and other policy makers about unique wound care clinical challenges and the impact on clinical practice of coding, coverage and payment issues – ultimately working to promote clinically sound coverage policies. n Demanding, ¬ through submitted comments and in-person meetings, greater transparency and accountability from the Medicare Administrative Contractors (MACs) who set the local coverage determinations (LCDs) that guide what wound care services, procedures and products are covered.

In 2016 the Alliance played an impactful role educating the FDA and its Advisory Panel by providing the relevant information and perspective which allowed the Panel to vote to recommend that antimicrobial wound dressings should be classified as “Class II (with special controls),” thus protecting access and availability of antimicrobial wound care dressings for patients and providers. We are currently communicating with FDA staff and will comment on the Agency’s proposed rule for classification of these important dressings when it issues. We value our relationship with EWMA as a member of its International Partners Organization and look forward to ongoing collaborations. Keep up with the Alliance’s ongoing activities at www.WoundCareStakeholders.org. Marcia Nusgart, R.Ph. Executive Director, Alliance of Wound Care Stakeholders

EWMA International Partner Organisation


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It’s a pleasure to update EWMA members on the activities of the Wounds Australia Wounds Australia continues to provide education and support to wound clinicians in Australia and contribute to publications and resources internationally.

Anne Buck CEO, Wounds Australia More information: www.woundsaustralia.au

In coming months, Wounds Australia will be releasing the consensus document ‘Application of Aseptic Technique in Wound Dressing Procedure’. This is the culmination of a long process, undertaken by the Wounds Australia Aseptic Technique sub-committee to produce a document that will provide much needed guidance for clinicians working across a range of settings. This publication was developed as a consensus document in recognition of the considerable gap in the evidence in many aspects that encompass aseptic technique in wound dressing procedure. The process included a literature review conducted by a research methodologist, reviews by an external group of experts and a consumer association, in addition to the contribution of the highly qualified sub-committee. In addition to our participation in the EWMA project on Surgical Site Infections, Wounds Australia continues to lead the development of the next edition of the Pan Pacific Clinical Practice Guideline for Prevention and Management of Venous Leg Ulcers. As a member of the Pan Pacific Pressure Injury Alliance, we are participating in the development of the next edition of the International Pressure Injury Guideline. Planning is well underway for the Wounds Australia 2018 Conference will be held in Adelaide between 24-26 October with the theme, Advancing Healing Horizons: Towards the cutting edge in wound care. International and national leaders in innovation, wound management and health economics will be invited to present on topics that providing cutting edge information as well as the history and current methods for a given topic. The Conference will see collaboration between a range of professionals, from scientists and researchers to clinicians, from nursing and medicine to allied health, and we welcome our colleagues from Europe. For more information see the conference website: www.woundsaust2018.com.au Between 16 - 20 October 2017, Wounds Australia will promote Wound Awareness Week. This important health promotion campaign will help raise awareness of the impact of chronic wounds and promote access to specialist wound care. Internally, Wounds Australia is continuing to nationalise our operations, grow our membership base and develop a strong national voice to advocate for better access to wound care.

Anne Buck CEO EWMA International Partner Organisation

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European Tissue Repair Society

The European Tissue Repair Society (ETRS) aims to promote knowledge and interchange between scientists, healthcare professionals, industry and other individuals who have an interest in tissue repair of all organs. It is our ambition to promote translation of scientific results from the laboratory to clinical situations and vice versa. ETRS prepares for the major challenges in wound care of the 21st century by seeking the involvement of young investigators and by developing new educational initiatives.

Dr. Magnus S. Ågren President of ETRS

Our mission is, to educate and expose “basic research trainees” to clinical aspects of wound repair and, vice versa, “clinical research trainees” to advanced laboratory-based research approaches, training in generic and transferable skills and provide networking and mentoring opportunities. To fulfil this goal a Junior Committee was established in 2010 to involve and foster interactions between young investigators. In 2016 the first and very successful ETRS Summer School at King’s College London, London was launched. This year’s Summer School was held September 11-12, 2017 (prior to the ETRS 26th Annual Meeting) in Brussels. ‘The Burn Wound’ was the main topic and many aspects in the treatment of patients with burn wounds were addressed and discussed. The ETRS 26th Annual Meeting 2017 was organised by Dr. Thomas Rose and his co-workers from the Burn Unit, Queen Astrid Military Hospital, Brussels in collaboration with the Belgian Royal Military Academy September 13-15, 2017 with the theme: (T)ISSUES OF WAR & PEACE. For more information please contact our Business Office (office@etrs.org) or visit our homepage (www.ertrs.org). ETRS has a longstanding relationship with EWMA which is most apparent during our annual meetings where we organise mutual guest sessions. The topic of this year’s ETRS guest session at EWMA was: ADVANCED THERAPIES FOR WOUND HEALING and took place on 5th May 2017 between 14:00-15:30. Treatments beyond “standard” wound dressings were addressed. Despite the increasing numbers of sophisticated wound dressings, impaired wound healing remains a huge clinical problem. Non-healing wounds do not only affect the patients’ quality of life but also have an enormous impact on healthcare systems.

Dr. Magnus S. Ågren President of ETRS

EWMA International Partner Organisation


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Make the latest research, clinical, and product information yours! A few examples of some recent peer-reviewed, multidisciplinary topics featured in Advances in Skin & Wound Care are: • Reducing Postsurgical Wound Complications: A Critical Review • Economic Evaluations of Strategies to Prevent Hospital-Acquired Pressure Injuries • Hyperbaric Oxygen Therapy: Exploring the Clinical Evidence

With your subscription, you’ll have first access to new issues and full access to the articles above and the complete archive of past issues available at woundcarejournal.com.

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EWMA Journal 

2017 vol 18 no 2

15th Scientific Meeting of the

Diabetic Foot Study Group of the WASD

37th annual meeting of the Berlin · Germany · 28 - 30 September 2018 Conference theme

Advancement of knowledge on all aspects of diabetic foot care


Main subjects during conference ● ● ● ● ● ● ● ● ● ● ●

6 - 8 September 2018 · Helsinki · Finland

Epidemiology Basic and clinical science Diagnostics Classification Foot clinics Biomechanics Orthopaedic surgery Infection Revascularisation Uraemia Wound healing and outcome

Abstract submission opens Registration opens Abstract submission deadline Early registration deadline

European Bone and Joint Infection Society

Main conference theme: Infection After Trauma The expected session topics will be: •

January 2018 February 2018 1 April 2018 6 June 2018

Prosthetic joint infection: diagnosis, treatment, prevention Traumatology - treatment of bone infection in tibia, pelvis, ankle and calcaneus  lasticSurgery-roleofflapreconstructioninbone P and joint infections, reconstruction of tissue defects after prosthetic joint infection of the knee Biomaterials – role of bone substitutes in the treatment of infected bone

We look forward to seeing you in Helsinki! www.ebjis2018.org


Conference Calendar 2017/18

For web addresses please visit www.ewma.org

Conferences 2017






Croatian Wound Association (CWA)

Prevention in Genetic of Chronic Wound


20 - 21



Symposium on Advanced Wound Care Fall meeting (SAWC)


20 - 22

Las Vegas

Nevada, US

5th International BiofilmCourse


26 – 27



10th Ibero-Latin American Congress about Ulcers and Wounds (SILaUhe)

October - November

31 - 3



2017 Diabetic Lower Extremity Symposium


2 - 3


Massachusetts, US

Symposium of Portuguese Wound Management Association (APTFeridas)


9 – 10



3rd Symposium of Association of Diabetic Foot Surgeons (A-DFS 2017)


9 – 11



Wounds UK Annual Conference


13 – 15



Fall conference of Canadian Association of Wound Care (CAWC)


16 - 19



Symposium of Czech Wound Management Society (CSLR)




Czech Republic

DEBRA International Congress


24 – 26


New Zealand

Dutch Knowledge Center for Wound Care Congress 2017 (WCS)

Unlimited Wound Care




The Netherlands

Belgian Federation of Wound Care (BEFEWO)

Dutch regional section





12th National Congress of Turkish Wound) Management Association (WMAT


14 – 17



Conferences 2018






Annual Congress of French & Francophone Wound Healing Society (SFFPC)

Updates in Wound Technology


21 - 23



National Conference of Finnish Wound Care Society (FWCS)


1 – 2



CNC VZW Wound Management Association meeting (CNC)





Annual congress of Norwegian Wound Care Society (NIFS)


8 – 9



CNC VZW Wound Management Association meeting (CNC)


22 - 23



National Pressure Ulcer Advisory Panel Annual Conference 2018 (NPUAP)



Las Vegas

Nevada, US

Swedish Wound Care Nurses Association Wound Conference (SSiS)


18 - 19



Tissue Viability Society Conference 2018 (TVS)


25 - 26



Symposium on Advanced Wound Care Spring (SAWC) & Wound Healing Society meeting (WHS)


25 - 29


North Carolina, US

15th Spring Symposium of European Academy of Dermatology and Venereology (EADV)


3 - 6



European Wound Management Association 2018 Conference (EWMA)


9 – 11



12th Symposium of National Advisory Group for the Study of Pressure Ulcers and Chronic Wounds (GNEAUPP)


16 - 18



17th Malvern Diabetic Foot Conference


16 - 18




From Innovation to Therapy

Pressure ulcers – Sharing internationally

New Frontiers in Wound Management

EWMA Journal 

2017 vol 18 no 2

Conference Calendar 2018

For web addresses please visit www.ewma.org

Conferences 2018






European Pressure Ulcer Advisory Panel Focus Meeting 2018 (EPUAP)

Pressure Ulcers in a Pediatric and Adult ICU Population: Science and Practice United


21 â&#x20AC;&#x201C; 23



Kent State University College of Podiatric Medicine Seminar 2018 (KSUCPM)


24 - 26



European Calcified Tissue Society Congress 2018 (ECTS)


26 - 29



19th Congress of European Federation of National Associations of Orthopaedics and Traumatology (EFORT)

May - June

30 - 1



9th International Lymphoedema Framework Conference (ILF)


6 - 9


The Netherlands

4th International course on the Neuropathic Osteoarthropathic Foot (Charcot)


21 - 23



37th Annual meeting of European Bone and Joint Infection Society (EBJIS)


6 - 8



20th Annual Meeting of European Pressure Ulcer Advisory Panel (EPUAP)


12 - 14



27th Congress of European Academy of Dermatology and Venereology (EADV)


12 - 16



15th Conference of Diabetic Foot Study Group (DFSG)


28 - 30



The European Association for the Study of Diabetes Annual meeting 2018 (EASD)


1 - 5



3rd Nordic Diabetic Foot Symposium 2018


6 - 7



EWMA Journalâ&#x20AC;&#x201A;

2017 vol 18 no 2


Cooperating Organisations AEEVH

Spanish Association of Vascular Nursing and Wounds www.aeevh.es


French Nurses’ Association in Stoma Therapy, Wound Healing and Wounds www.afiscep.be


Italian Nurses’ Cutaneous Wounds ­Association www.aislec.it


Italian Association for the study of Cutaneous Ulcers www.aiuc.it

AMP Romania

Wound Management Association Romania www.ampromania.ro


Portuguese Association for the Treatment of Wounds www.aptferidas.com


All Wales Tissue Viability Nurse Forum www.welshwoundnetwork.org


Austrian Wound Association www.a-w-a.at


Belgian Federation of Woundcare www.befewo.org


Portuguese Wound Society www.sociedadeferidas.pt


Finnish Wound Care Society www.shhy.fi


Associated Group of Research in Wounds www.gaif.net


National Advisory Group for the Study of P ­ ressure Ulcers and Chronic Wounds www.gneaupp.org


Hellenic Society of Wound Healing and Chronic Ulcers www.hswh.gr


Chronic Wounds Initiative www.ic-wunden.de


Latvian Wound Treating ­Organisation


The Leg Ulcer Forum www.legulcerforum.org


Lithuanian Wound Management Association www.lzga.lt


Macedonian Wound Management Association

National Association of Tissue Viability Nurses, S ­ cotland


Hungarian Association for the Improvement in Care of Chronic Wounds and Incontinentia www.sebinko.hu


The Spanish Society of Wounds www.sociedadespanolaheridas. es


The French and Francophone Society f Wounds and Wound Healing www.sffpc.org


Swedish Wound Care Nurses Association www.sarsjukskoterskor.se


Slovak Wound Care Association www.ssoor.sk


The Slovak Wound Healing Society www.ssplr.sk/en

STW Belarus

Icelandic Wound Healing ­Society www.sums.is


Serbian Wound Healing Society www.lecenjerana.com


Swedish Wound Healing Society www.sarlakning.se




Croatian Wound Association www.huzr.hr



German Wound Healing Society www.dgfw.de

Polish Wound Management Association www.ptlr.org.pl



Danish Wound Healing Society www.saar.dk


Norwegian Wound Healing Association www.nifs-saar.no

Dutch Organisation of Wound Care Nurses www.novw.org


Serbian Advanced Wound Management Association www.lecenjerana.com


Hungarian Wound Care Society www.euuzlet.hu/mskt/






Czech Wound Management Society www.cslr.cz

Swiss Association for Wound Care (French section) www.safw-romande.ch

Society for the Treatment of Wounds (Gomel, Belarus) www.burnplast.gomel.by




Maltese Association of Skin and Wound Care www.mwcf.madv.org.mt/

Bulgarian Wound Association www.woundbulgaria.org

Clinical Nursing Consulting – Wondzorg www.wondzorg.be



Tissue Viability Society www.tvs.org.uk

Association for Wound Management of Bosnia and Herzegovina www.urubih.ba


Ukrainian Wound Treatment Organisation www.uwto.org.ua

Swiss Association for Wound Care (German section) www.safw.ch

EWMA Journal 

2017 vol 18 no 2


Cooperating Organisations (cont.) V&VN

Decubitus and Wound Consultants, ­Netherlands www.venvn.nl

WCS Knowledge Center Woundcare www.wcs.nl


Wound Management ­Association of Ireland www.wmai.ie



European Tissue Repair Society www.etrs.org


International Federation of Podiatrists - Fédération Internationale des Podologues www.fip-ifp.org


Int. Wound Infection Institute www.woundinfection-institute. com


International Lymphoedema ­Framework www.lympho.org


Wound Management Association of Kosova

Korean Wound Management Society www.woundcare.or.kr/eng





Wound Management Association Slovenia www.dors.si

Wound Management ­Association Turkey www.yaradernegi.net

New Zealand Wound Care Society www.nzwcs.org.nz

Iberolatinoamerican Society of Ulcers and Wounds www.silauhe.org


International Partner Organisations Alliance of Wound Care Stakeholders www.woundcarestakeholders. org


Association for the Advancement of Wound Care www.aawconline.org


Canadian Association of Wound Care www.cawc.net


World Alliance for Wound and Lymphedema Care www.wawlc.org

Wounds Australia

Wounds Australia www.awma.com.au


Chinese Tissue Repair Society www.chinese-trs.com/en


European Council of Enterostomal Therapy www.ecet-stomacare.eu

2017 vol 18 no 2

Eucomed Advanced Wound Care Sector Group www.eucomed.org


International Compression Club www.icc-compressionclub.com

Associated Organisations Leg Club

Lindsay Leg Club Foundation www.legclub.org


The Lymphoedema Support Network www.lymphoedema.org/lsn

Media Partner JWC

Journal of Wound Care www.magonlinelibrary.com


Practical Patient Care www.practical-patient-care.com

For more information about EWMA’s Cooperating Organisations please visit www.ewma.org

Diabetic Foot Study Group www.dfsg.org






European Federation of National Associations of ­Orthopaedics and Traumatology www.efort.org

European Society for Vascular Surgery www.esvs.org

Other Collaborators

Debra International

Dystrophic Epidermolysis Bullosa Research Association www.debra.org.uk

EWMA Journal 

Brazilian Wound M ­ anagement ­Association www.sobenfee.org.br


European Academy of Dermatology and Venereology www.eadv.org

European Burns Association www.euroburn.org


European Pressure Ulcer Advisory Panel www.epuap.org


The European Society for Clinical Nutrition and Metabolism www.espen.org


5 Editorial. Sebastian Probst, Editor of EWMA Journal

Science, Practice and Education 7 Evaluation of a newly designed moisture management product for use in women giving birth at the Canberra Centenary Hospital for Women and Children. Broom M, Dunk A M, Sheridan D, McLeod M 15 Advancing professional health care practice and the issue of accountability. Cornock M 21 The changing US healthcare climate: What does it mean for wound care? Nusgart M 27 Core outcome set for Venous leg ulceration “CoreVen” Hallas S, Nelson A, O’Meara S, Gethin G 33 Negative Pressure Wound Therapy: Future Perspectives Apelqvist, J, Willy C, Fagerdahl A, Fraccalvieri M, Malmsjö M, Piaggesi A, Probst A, Wowden P

Cochrane Reviews 39 Abstracts of Recent Cochrane Reviews Rizzello G

EWMA 50 EWMA’s focus areas for the years 2017 - 2019 Bale S 52 EWMA 2018 Conference in Krakow, Poland 56 EWMA 2017 Conference in Amsterdam, the Netherlands 60 New EWMA Council Members 61 Appreciations: Leaving Council Members 64 EWMA Journal Previous Issues and Other Journals 66 EWMA Publications 69 Activities of the Cooperating Organisations during the EWMA 2017 Conference in Amsterdam Seppänen S 72 Launch of the Alliance for Research and Innovation in Wounds Gethin G, Coyne P, McIntosh C 74 Joint EPUAP & EWMA Pressure Ulcer (PU) Prevention & Patient Safety Advocay Project Moore Z, Soriano J V, Pokorna A, Schoonhoven L, Vuagnat H 76 Participation in the European Joint Action on Antimicrobial Resistance and Healthcare-associated Infections 78 New corporate sponsors 81 EWMA News

Organisations 82 Recognintion of wound care centres in Switzerland Wüthrich J, Kohler E, Mayer D, Von Siebenthal D, Signer M 86 Polish Wound Management Association. Sopata M 87 The International Federation of Podiatrists. Garoufalis M G 88 Association for the Advancement of Wound Care. Bohn G 90 Alliance of Wound Care Stakeholders. Nusgart M 91 Wounds Australia. Buck A 92 European Tissue Repair Society. Ågren M S 94 Corporate Sponsors 96 Conference Calendar 98 Cooperating Organisations, International Partners and Other Collaborators

Profile for EWMA European Wound Management Association

EWMA Journal October 2017 (2)  

EWMA Journal October 2017 (2)

EWMA Journal October 2017 (2)  

EWMA Journal October 2017 (2)

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