Journal of the European Wound Management Association_Volume 21 (1), November 2020

O F T H E E U R O P E A N W O U N D M A N A G E M E N T A S S O C I AT I O N Volume 21 ¡ Number 1 ¡ November 2020

Translation and cross-cultural adaptation of the Venous Leg Ulcer Self Efficacy Tool for use in a Swiss-French setting Management of an oncological wound: Diagnosis, conflicting therapies and decision-making Wound care within Flemish residential care centres: An update Consent to treatment Seek, and ye shall find: Efficacy of proactive screening for diabetic foot ulceration in the community autonomously performed by nurses A silver-based antimicrobial dressing for the prevention of surgical site infection - a pilot study Clinical characteristics of lower extremity ulcers Community-based wound care in the Netherlands

Journal of the European Wound Management Association ISSN number: 1609-2759 Volume 21, No 1, November, 2020 Journal of the European Wound Management Association

Editorial Board Sebastian Probst, Switzerland, Editor Georgina Gethin, Ireland, Editor Alberto Piaggesi, Italy, Editor in Chief Andrea Pokorná, Czech Republic Dimitri Beeckman, Belgium Nicoletta Frescos, Australia

O F T H E E U R O P E A N W O U N D M A N A G E M E N T A S S O C I AT I O N

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Editorial

Georgia Gethin, Sebastian Probst

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Translation and cross-cultural adaptation of the Venous Leg Ulcer Self Efficacy Tool for use in a Swiss-French setting

Mathieu Turcotte, Monika Buehrer Skinner, Sebastian Probst,

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

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Management of an oncological wound: Diagnosis, conflicting therapies and decision-making

Tommaso Bianchi, Ambra Di Altobrando, Yuri Merli, T artari Manfredi Barbara, Sara Rowan, Maria Musella, M Musella, Laura Moda, Annalisa Patrizi

Layout: Nils Hartmann, Open design/advertising

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Wound care within Flemish residential care centres: An update

Geert Vinck

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Consent to treatment

Mary E. O’Hara

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Seek, and ye shall find: Efficacy of proactive screening for diabetic foot ulceration in the community autonomously performed by nurses

Letizia Pieruzzi, Elisabetta Iacopi, Maria Grazia Buccarello, Ludovica Tamburini, Chiara Goretti, Graziano Di Cianni, Alberto Piaggesi

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A silver-based antimicrobial dressing for the prevention of surgical site infection - a pilot study

Jan Stryja, Daniel Riha, Jerzy Szkatula

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Clinical characteristics of lower extremity ulcers

Kirsi Isoherranen, Milla Kallio, Julie Jordan O`Brien, Heli Lagus

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Community-based wound care in the Netherlands

EWMA website www.ewma.org

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

The next issue will be published Spring 2021. Prospective material for publication must be with the EWMA Secretariat as soon as possible and no later than 15 January 2021.

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

Jacques Oskam, Annemiek Stienstra

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Abstracts of recent Cochrane Reviews

Gill Rizzello

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,

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Journal of EWMA - Previous issues

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JOURNAL EDITORIAL

DOI: 10.35279/jewma202011.01

This editorial is dedicated to the WHO Assembly 2020 Year of the Nurse and Midwife

T

he year 2020 marks the 200th anniversary of the birth of Florence Nightingale. She remains, undoubtedly, a role model and leader for nursing, and much of her teachings and practices are as pertinent today as they were in the 1800s. In the 1870s, she wrote in her personal diary that ‘it would take 100 to 150 years to see the kind of nursing she envisioned’, a truly remarkable statement in this year, 2020 [1870 + 150 = 2020].

Her writings sparked worldwide health care reform, and in 1860 she established St. Thomas’ Hospital and the Nightingale Training School for Nurses. She advocated for whole health care systems where the focus was not only on the disease, but also on the individual. She was one of the first to recognise the importance of hand washing to prevent the transmission of infection, a factor that is of critical importance today in preventing the transmission of COVID-19. She was an excellent data journalist and developed, among other things, the visual presentation of data, including the pie chart.

So, where is nursing in 2020? According to the WHO [https://www.who.int/news-room/fact-sheets/ detail/nursing-and-midwifery], nurses and midwives account for 50% of the global health workforce.

They are the largest sector of the health care workforce; they play a critical role in health promotion, disease prevention and delivering primary and community care, but worryingly, from a global perspective, we will need an additional 9 million nurses and midwives by 2030 to achieve the WHO’s Sustainable Development Goals and to continue to deliver and provide health care.

Nurses play a key role in the field of wound management. They provide the majority of wound care to patients, mainly in the community setting, and this can account for up to 68% of their time.1 Recently, we have shown the significant role that nurses play as research leaders in wound care, particularly in areas of research that inform clinical practice guidelines and thus clinical practice. It is time, therefore, to recognise this important group in 2020.1 Nurses do not work in isolation; indeed, optimal patient care requires a multidisciplinary approach.

However, nursing and the recognition of nursing as a profession – while universally admired – is not universally acknowledged or recognised. Variations exist in levels of education and working practices, thus part of acknowledging 2020 as WHO’s Year of the Nurse and Midwife is to advocate for our colleagues around the globe, to support initiatives for further education and to promote leadership in nursing.

The current COVID-19 pandemic has put a spotlight on the various roles that nurses play, not only in health care in general, but also on the front line in the management of this disease. Nurses have demonstrated professionalism, innovation, leadership and a commitment to the lives of those they serve. We thank them, one and all.

EWMA plays a key role in supporting multidisciplinarity and, year on year, recognises nurses through their leadership of specific committees, working groups, documents and in senior executive positions.

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JOURNAL EDITORIAL

We look forward to continuing this into the future and advancing the roles not only of nurses but of all professions.

This issue of the Journal of EWMA marks the first issue in our new format and, with a slight change in our title, and includes eight original manuscripts. They include amongst others an overview of wounds present in Belgium residential care centres and a test of the surgical site infection-related serviceability of a novel silver-based dressing material for acute wound management. A case report from Italy illustrates the care of a non-HIV-positive patient who contemporaneously suffered from Kaposi’s sarcoma and bullous pemphigoid. Additionally, we present a manuscript where the efficacy of proactive screening of patients at risk of developing a diabetic foot ulcer was measured. One article for clinical practice discusses key components of a valid consent to treatment, as well as different forms of consent. Finally, a methodological study illustrates the translation and cross-cultural adaptation of an original tool from English into Swiss French.

Georgina Gethin, Editor Senior Lecturer School of Nursing and Midwifery, Aras Moyola, NUI Galway, Galway, Ireland and Sebastian Probst, Editor and President-Elect Professor of Tissue Viability and Wound Care Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland

REFERENCES 1. Gethin G, Probst S, Weller C, Kottner J, Beeckman D. Nurses are research leaders in skin and wound care. Int Wound J. 2020.

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Why is complete arterial assessment necessary for all high-risk patients?

Diagnosing PAD in asymptomatic patients Ankle-Brachial Index (ABI) is a highly specific method of vascular risk assessment, namely for diagnosing Peripheral-Arterial Disease (PAD), especially in otherwise asymptomatic patients.

The measurement of ABI should be performed on all patients above 50 with any of the cardiovascular risk factors (dyslipidemia, hypertension, diabetes, obesity, and smoking) and on all patients above 65, regardless of risk factors.(1) (1) TASC II 2017

“

“

...media sclerosis in patients indicates the need for both ABI and TBI evaluations in order to detect PAD.(2)

(2) Seong Chul Park, et al, Utility of Toe-brachial Index for Diagnosis of Peripheral Artery Disease. Archives of plastic surgery.

39. 227-31. 10.5999/aps.2012.39.3.227.

Although it is a very objective diagnostic method, it is less reliable in cases where the arteries are calcified and can therefore not be compressed: the presence of media calcinosis produces falsely elevated values.

The importance of Toe-Brachial Index There are many cases, where peripheral artery stenosis is present even when the ABI is normal or elevated. In such cases, it is recommended to perform a Toe-Brachial Index (TBI) measurement as the vessels in the toes are generally unaffected by media sclerosis. Patients with conditions associated with calcified arteries, such as diabetes, chronic kidney disease, advanced age, patients with extensive wounds or lymphoedema and

Crucial measurement for diabetic patients Even though PAD is very common in patients with diabetes, it remains severely under-recognised in this type of population. Diagnosis is often difficult because diabetes is associated with peripheral neuropathy, as this condition could mask the pain. One third of diabetic patients with PAD have intermittent claudication. These patients are much more prone to wounds and complications and should be routinely checked for PAD using ABI and TBI.

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S C I E N C E , P R A C T I C E A N D E D U C AT I O N

DOI: 10.35279/jewma202011.02

Mathieu Turcotte, MScN, RN1, Monika Buehrer Skinner, DrPH, MPH&TM, BNSc, RN2 Sebastian Probst, DClinPrac, MScN RN, Professor of Tissue Viability and Wound Care3

Translation and cross-cultural adaptation of the Venous Leg Ulcer Self Efficacy Tool for use in a Swiss-French setting Venous leg ulcers are lesions between the ankle joint and the knee caused by chronic venous insufficiency. The Venous Leg Ulcer Self Efficacy Tool (VeLUSET) was developed to measure self-care and self-efficacy in Englishspeaking persons with venous leg ulcers. This study describes the translation and cross-cultural adaptation of the original version of the VeLUSET from English into Swiss French.

Keyword s:

venous leg ulcers; translation; cross-cultural adaptation; self-efficacy ABSTRACT Background Venous leg ulcers are slow-healing wounds.

Objective The aim of this study was to translate and crossculturally adapt the original version of Venous Leg Ulcer Self Efficacy Tool (VeLUSET) from English into Swiss French.

Method/Results A cross-cultural research study in three outpatient clinics in western Switzerland was conducted following1 translation of the original instrument into Swiss French by two independent translators,2 construction of a consensus version based on both translations,3 two independent back translations of the consensus version into English,4 review by an expert committee and construction of a draft questionnaire,5 testing of the draft questionnaire on people with a venous leg ulcer and6 construction of the final questionnaire version.

Conclusion This process of translation and cultural adaptation produced a new version of the VeLUSET for validation and later use among the French-speaking population of Switzerland. An upcoming separate study will investigate the psychometric properties of the adapted questionnaire in the new setting.

Implication for clinical practice People in different settings have different cultural norms, literacy levels and beliefs and might thus respond differently to clinical tools. The implication for clinical practice is that a translated clinical tool, such as the VeLUSET questionnaire, might not measure the same concepts in different cultural settings. When using clinical tools, clinicians need to consider the origin of development and testing of the tool and whether cultural expectations, literacy levels or beliefs impact responses and thus the interpretation of the results of the tool.

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1La

Source, HES-SO University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.

2Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.

3Geneva School of Health Sciences, HES-SO University of Applied Sciences and Arts Western Switzerland, Geneva, Switzerland.

Correspondence: m.turcotte@ecolelasource.ch · Conflicts of Interest: None

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Key messages - The seven-step method of Sousa and Rojjanas rirat provided an accepted best practice structure for translating the English version of the VeLUSET into Swiss French.

- Further, the translated VeLUSET_FR was culturally adapted for the Swiss French setting.

- The translated and adapted version of the VeLUSET questionnaire is ready for validation to establish whether it can be used to measure the self-care of Swiss French venous ulcer patients.

INTRODUCTION Venous leg ulcers (VLUs) are lesions between the ankle joint and the knee caused by chronic venous insufficiency. The occurrence ranges between 0.8 and 2.2 per 1000 people/year.1 Healing times of VLUs are long, and up to 70% of the patients suffer a recurrence within three months after wound closure.2-4

These wounds have a negative impact on all aspects of daily life.5-8 Current therapeutic approaches for VLUs focus on wound healing and on preventive measures such as wearing compression stockings, performing leg and ankle exercises, leg elevation and a balanced diet.4,911 However, adherence to therapeutic recommendations is poor and thought to be due to insufficient knowledge.12-13 This knowledge deficit is related to a low level of self-care and self-efficacy.9-11 Evidence demonstrates that self-efficacy is a facilitator in the adoption of self-care, which is important in preventing the recurrence of ulcers.14-15 Based on this sociocognitive theory, it can be deduced that the ability to adapt behaviour can first be quantified by measuring self-efficacy and second be influenced by targeting self-efficacy.14,16 Currently, only one instrument to measure self-efficacy in the VLU population has been developed and validated, the Venous Leg Ulcer Self Efficacy Tool (VeLUSET).16 This English-language tool consists of general statements about wearing

Table 1. Study Phases and Steps Steps Sousa and Rojjanasrirat

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Selected for the study

1

Forward translated to the target language (TL) by two independent translators

Idem

2

Comparison of the two translations and discussion of the discrepancies of the preliminary initial translated version of the instrument in the target language (PI-TL)

3

Blind back translation of the PI-TL by two inde- Adapted pendent translators

4

Comparison of the two back-translated versions of the instrument (B-TL1 and B-TL2)

5

Pilot testing of the draft version of the instrument in the target language (P-FTL), sampling 10-40 individuals with ‘with questions that are clear and not dichotomous’’Conceptual equivalence (clarity) evaluated by 6-10 members of an expert panel.

Separate study18

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Preliminary psychometric testing of the P-FTL with a bilingual sample

Not undertaken

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Psychometric testing of the P-FTL

Separate study18

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compression stockings (5 items) and of affirmations about daily self-care tasks (16 items) with which people can agree (or not) on a scale from 0 (total disagreement) to 10 (total agreement). Mean scores for each item can be compared. Its internal reliability as assessed with Cronbach’s α is 0.931.16 This study is the first of two phases of a methodological study. The aims of the first phase are the translation and cross-cultural adaptation of the original English VeLUSET into Swiss French, based on the seven-step methodology of Sousa and Rojjanasrirat.17 METHOD This study describes the translation and cross-cultural adaptation of the original version of the VeLUSET from English into Swiss French. The second step of the validation of the instrument, the assessment of the psychometric properties of the translated version, is described elsewhere.18 Instrument The original version of the VeLUSET was developed to measure self-care and self-efficacy in Englishspeaking persons with VLU. The tool assesses 30 items on a self-reporting basis. The items assess the 5 dimensions of self-efficacy for persons with VLU: conducting general self-care (5 items), daily self-care tasks (12 items), normal living (4 items), developing expertise (6 items) and avoiding trauma (3 items).

The scale was developed using a focus group approach of persons with VLU. The items were written in the form of statements based on self-efficacy findings.

This formulation assessed a person’s understanding of the aetiology of his or her ulcer and provides the latest recommendations on self-care to be adopted.

The scale ranges between 0 (totally disagree) and 10 (totally agree). The reported Cronbach’s α of the total scale has been reported as 0.931 and 0.834, with 0.851, 0.753, 0.828 and 0.804 for the subscales, respectively. The assessed test-retest reliability over a four-week interval was excellent (r = 0.92; n = 20; P < 0.001).16 Translation process The accepted method of instrument translation and cultural adaptation suggested by Sousa and Rojjanasrirat was adapted using four of their seven steps (see figure 1) that are applicable to the context of this study. Additionally, an expert committee was consulted; it focused on the technicality of the instrument and the precision of the terms to be translated.17 All experts concurrently considered the content, semantic, technical, criterion and conceptual equivalence of the tool. Step six of the pilot test was not done due to the non-availability of bilingual participants, while the seventh step of psychometric testing was conducted in a separate study and is described elsewhere.18

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Table 2. Translation process - an example Original English Version

I am confident that: I understand why I need to wear my compression stockings for the rest of my life.

Forward translation

Backward translation

Translator 1: Je suis convaincu de ce qui suit: je comprends pourquoi je dois porter les bas de contention pour le restant de mes jours.

Translator 3: I have confidence in the fact that: I understand why I will need to wear my compression stockings for the rest of my life.

Translator 2: J’ai confiance dans le fait que: je comprends pourquoi j’aurais besoin de mettre mes bas de compression pour le restant de ma vie

Translator 4: I am confident that: I understand why I will need to put my compression stockings for the rest of my life.

Draft version

J’ai confiance que: je comprends pourquoi je dois porter les bas de compression pour le restant de mes jours.

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RESULTS The translation process is outlined in the following description of the four steps described by Sousa and Rojjanasrirat.17 Four (French and English) bilingual experts with similar academic backgrounds – three PhD holders with a health science background and a translator unfamiliar with medical terminology – carried out the translation blindly and independently.

Two experts independently forward translated the instrument from the original language to the target language. As a second step, two other experts back translated the translated version into the original language. The four translators and the first and last authors of this article then compared the two backtranslated versions with the original version, and a consensus version was elaborated. The example in Table 2 illustrates the process.

DISCUSSION The aim of this study was to translate and crossculturally adapt the original version of the VeLUSET

from English into Swiss French using an adapted version of the accepted method of Sousa and Rojjanasrirat.17 This adaptation was crucial to responding to the specific circumstances of the setting and to ensure a coherent methodology.17 It is essential that the literal meaning of a word be translated, along with its relationship to the context.19 This is important because some terms or concepts used in health care language do not exist in other languages. Evidence shows people from different cultural backgrounds respond differently to clinical tools.20

Conclusion and recommendation for practice The translation and cultural adaptation of the VeLUSET questionnaire from an English-speaking setting to a French-speaking setting in Switzerland will now allow for the assessment of psychometric properties.

REFERENCES 1. Berenguer Pérez M, López-Casanova P, Sarabia Lavín R, González de la Torre H, Verdú-Soriano J. Epidemiology of venous leg ulcers in primary health care: Incidence and prevalence in a health centre-A time series study (2010-2014). Int Wound J. 2019 Feb; 16(1):256‑65.

2. Abbade LPF, Lastoria S, de Almeida Rollo H, Ometto Stolf H. A sociodemographic, clinical study of patients with venous ulcer. Int J Dermatol. 2005 Dec; 44(12):989 92.

3. McDaniel HB, Marston WA, Farber MA, Mendes RR, Owens LV, Young ML, et al. Recurrence of chronic venous ulcers on the basis of clinical, etiologic, anatomic, and pathophysiologic criteria and air plethysmography. J Vasc Surg. 2002 Apr; 35(4):723 8.

9. Finlayson K, Edwards H, Courtney M. Factors associated with recurrence of venous leg ulcers: A survey and retrospective chart review. Int J Nurs Stud.

2009 Aug; 46(8):1071 8.

10. Finlayson K, Edwards H, Courtney M. Relationships between preventive activities, psychosocial factors and recurrence of venous leg ulcers: A prospective study. J Adv Nurs. 2011 Oct; 67(10):2180 90.

11. Brown A. Self-care strategies to prevent venous leg ulceration recurrence. Pract Nurs. 2018 Apr; 29(4):152 8.

4. Finlayson K, Wu M-L, Edwards HE. Identifying risk factors and protective factors for venous leg ulcer recurrence using a theoretical approach: A longitudinal study. Int J Nurs Stud. 2015 Jun; 52(6):1042 51.

12. Finlayson K, Edwards H, Courtney M. The impact of psychosocial factors on adherence to compression therapy to prevent recurrence of venous leg ulcers. J Clin Nurs. 2010 May; 19(9 10):1289 97.

5. Green J, Jester R. Health-related quality of life and chronic venous leg ulceration: Part 1. Br J Community Nurs. 2009 1 Dec; 14(6):12 7.

13. Van Hecke A, Grypdonck M, Beele H, Vanderwee K, Defloor T. Adherence to leg ulcer lifestyle advice: Qualitative and quantitative outcomes associated with a nurse-led intervention. J Clin Nurs. 2011 Feb; 20(3/4):429 43.

6. Green J, Jester R, McKinley R, Pooler A. Patient perspectives of their leg ulcer journey. J Wound Care.

2013 Feb; 22(2):58 66.

7. Green J, Jester R, McKinley R, Pooler A. The impact of chronic venous leg ulcers: A systematic review. J Wound Care. 2014 2 Dec; 23(12):601 12.

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8. Guarnera G, Tinelli G, Abeni D, Di Pietro C, Sampogna F, Tabolli S. Pain and quality of life in patients with vascular leg ulcers: An Italian multicentre study. J Wound Care. 2007 Aug; 16(8):347 51.

15. Richard AA, Shea K. Delineation of self-care and associated concepts: Self-care concept delineation. J Nurs Scholarsh. 2011 Jul; 43(3):255-64.

16. Brown A, Kendall S, Flanagan M, Cottee M. Encouraging patients to self-care—The preliminary development and validation of the VeLUSET©, a self-efficacy tool for venous leg ulcer patients, aged 60 years and over. Int Wound J. 2014 Jun; 11(3):326 34.

17. Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline: Validation of instruments or scales. J Eval Clin Pract. 2011 Apr; 17(2):268 74.

18. Probst S, Turcotte M, Buehrer Skinner M. Internal consistency and reliability of the Swiss-French translation of the Venous Leg Ulcer Self Efficacy tool (VeLUSET). BMJ Open. 2019 Dec; 9(12):e031529.

19. Esposito N. From meaning to meaning: The influence of translation techniques on non-English focus group research. Qual Health Res. 2001 Jul; 11(4):568‑79.

20. Dunckley M, Hughes R, Addington-Hall JM, Higginson IJ. Translating clinical tools in nursing practice. J Adv Nurs. 2003 Nov; 44(4):420‑6.

14. Bandura A. Self-efficacy mechanism in human agency.

Am Psychol. 1982; 37(2):122 47.

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DOI: 10.35279/jewma202011.03

Tommaso Bianchi MD PhD1, Ambra Di Altobrando A MD2, Yuri Merli MD2, Federico Tartari MD2, Barbara Manfredi CNS3, Sara Rowan PgDip, Maria Musella CNS4, M Musella CNS3, Laura Moda CNS3, Annalisa Patrizi MD2

Management of an oncological wound:

Diagnosis, conflicting therapies and decision-making This article presents the case of a non-HIV-positive patient who contemporaneously suffered from Kaposi’s sarcoma and bullous pemphigoid.

Kaposi’s sarcoma is a rare low-grade vascular tumour associated with human herpes virus 8 infection, while bullous pemphigoid is the most common autoimmune subepidermal blistering disease in western countries.

Keywords:

bullous pemphigoid; kaposo sarcoma; chronic wound

INTRODUCTION Kaposi’s sarcoma (KS) is a rare low-grade vascular tumour associated with human herpes virus 8 infection (HHV-8).1 Bullous pemphigoid (BP) is the most common autoimmune subepidermal blistering disease in western countries, and typically affects the elderly.2 We present the case of a non-HIV-positive patient who contemporaneously suffered from Kaposi’s sarcoma and bullous pemphigoid.

Oncological wounds are often large, disfiguring, exuding, malodorous and hard to manage. However, while many oncological wounds do not have these properties, their diagnosis and management can still pose a challenge. For example, diagnosis of Kaposi’s sarcoma or epithelial skin tumours is particularly difficult because they are often mistaken for common types of chronic wounds, such as venous leg ulcers or diabetic foot ulcers.

CASE REPORT A 94-year-old male patient was referred to our dermatological Wound Care Clinic at the University Hospital of Bologna for a wound on the plantar area of his right foot.

The lesion, measuring 12 x 8 cm, had been present for a few months and was progressively worsening.

The patient had previously been managed by the district nurses.

The patient suffered from diabetes mellitus type 2 with mild symptoms of diabetic neuropathy, dyslipidaemia, chronic obstructive pulmonary disease, ischaemic heart disease, hypertension, hyperthyroidism and benign prostatic hypertrophy.

The patient’s medical history included a recent BP diagnosis, for which he had been treated with systemic

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1. ALA Wound Care Unit, Dermatology Division, Azienda USL di Bologna, Bologna, Italy 2. ALA Wound Care Unit, Dermatology Division, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy 3. ALA Wound Care Unit, Dermatology Division, Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy 4. C3S – Clinical Scientific Support, Florence, Italy

Correspondence: tommaso.b.bianchi@gmail.com · Conflicts of Interest: None

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Figure 1. At admission - state of the leg and Bullous Pemphigoid eroded blisters after 2 months of immunosuppressive treatment.

Figure 2. At admission - wound located in plantar area of left foot: hyperplastic violaceous granulation tissue suggesting for Kaposi Sarcoma.

corticosteroids for 2 months, and relapsing episodes of small leg ulcers resulting from eroded blisters connected to BP (Fig. 1), which had completely regressed after systemic immunosuppressive therapy. The plantar lesion had been present for about 3 months, but it was non-healing and it was deteriorating.

The patient could still walk and carry out the main activities of daily life independently, using orthopae-

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dic pressure relieving shoes and a walking stick. He complained of not being able to move as freely as he used to due to the large amount of exudate and the frequent dressing changes. The patient lived in a retirement home with the support of his two sons, who accompanied him to the Wound Care Clinic for dressing changes and medical visits.

On examination, the wound presented heavily ex-

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Figure 3. State of the wound 14 months into the treatment. Worsening of the KS is evident. Wound with hyperkeratotic necrotic swelling linked to the tumor.

uding, violaceous granulation tissue and macerated hyperkeratotic borders (Fig. 2). The right leg was oedematous.

Skin swabs were carried out in order to profile the cutaneous microbiota and perform antibiotic-susceptibility tests. Once the skin swabs were executed, the patient was treated for his wounds with alginatebased dressings containing silver and multi-layer compressive bandaging.

A week later the swabs showed no signs of infection.

However, despite wound management with advanced dressings twice a week, no resolution or improvement was detected after a month’s therapy. Due to the wound’s chronic nature, a skin biopsy for histopathological examination was performed. It revealed an increased number of atypical vascular structures with thinned walls and proliferating bundles of spindle endothelial cells. The clinical picture, added to the histological features, suggested KS as a possible diagnosis. Complementary immunohistochemistry was carried out and the HHV-8 positivity confirmed the diagnosis.

The screening exams performed to exclude systemic involvement, including chest X-ray, abdominal ultrasound and digestive endoscopy, were all negative.

Therefore, an oncological consultation was promptly requested. Following a team meeting, conservative

palliative therapy was chosen because of the patient’s multiple comorbidities and advanced age. The treatment consisted of exudate management and bioburden control. BP was treated by alternating short cycles of systemic steroids with topical steroid-based ointments.

The patient is currently in the care of our outpatient Wound Care Clinic. More than one year after the KS diagnosis, the clinical picture has progressively worsened (Fig. 3).

The patient maintained a good degree of autonomy in his activities of daily living for about 4 months.

Afterwards the patient was no longer able to ambulate independently, although he is still able to walk indoors with the aid of a walker. The patient is still in good cognitive condition, scoring 26 points on the Mini-Mental State Examination.3 DISCUSSION Kaposi’s sarcoma risk is increased in immunocompromised patients, including those undergoing immunosuppressive therapy for autoimmune bullous diseases.

Conversely, HHV-8 infection has been hypothesised to be a triggering factor of bullous diseases, especially pemphigus.4 The main goals of KS therapy are symptom palliation, prevention of disease progression and tumour

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shrinkage. Local treatments, including radiation therapy, intra-lesional chemotherapy and topical alitretinoin, can manage symptomatic bulky KS lesions or achieve better cosmetic results, but they do not prevent disease progression.5 Systemic treatment with chemotherapy, liposomal anthracyclines, taxanes and anti-HHV-8 therapy are used in cases of advanced disease or rapid tumour progression.6 BP is an autoimmune disease that can be triggered by drugs such as diuretics, antiarrythmics–antihypertensives, antitumor necrosis factor agents, antibiotics and worsened by physical stimuli, including radiotherapy.7 BP treatment includes mainly immunosuppressive systemic therapies.2 The treatment of choice for KS, in this case, would have been radiotherapy, which could have worsened BP. However, for BP, the therapy of choice, systemic immunosuppressive drugs, would have led to a higher risk of infection and potentially a faster KS progression. People with oncological wounds suffer from a devastating symptom burden, such as pain and discomfort, irritation or itching, exudate, odour, infection and slough or necrosis; due to the chronic nature of the condition, deterioration is inevitable.8–10 In this patient’s case, currently, most of the wound bed is covered with non-vitalised tissue, and the surrounding skin is hyperkeratotic with swelling linked to the tumour. However, the wound is free of infection. The right treatment approach is to take into account the patient and family’s goals of care in all aspects of decision-making. The need for balance between the disease treatment and the patient’s need for autonomy and less frequent dressing changes

motivated our clinical intervention. The frequency of the dressing changes depends still on the exudate and inflammation, but our objective is to find a way to reduce them. For the team, it is frustrating to witness the worsening of the wound and be unable to heal it.

CONCLUSION The patient was affected by two debilitating chronic diseases, for which the treatment for each one worsened the condition of the other. A difficult clinical decision had to be made. From the holistic evaluation of the patient and his family it became apparent that quality of life was the most important factor to take into consideration. Therefore, conservative therapy was undertaken.

BP was treated using short cycles of systemic steroids that were then alternated with topical steroids only, while the lesion caused by KS was managed using antimicrobial dressings and multi-layer compression bandaging to address the exudate, the risk of infection and possibly pain and to contain the oedema.

In this case the additional presence of BP, which could present with erosions and ulcers, was a confounding factor.

The primary obstacle for this patient was the delay in having a correct diagnosis. In this case it took around two months before the patient was referred to a specialised centre and another month before we carried out the biopsy confirming the oncological aetiology of the wound.

REFERENCES 1. Goncalves PH, Ziegelbauer J, Uldrick TS, Yarchoan R. Kaposi sarcoma herpesvirus-associated cancers and related diseases. Curr Opin HIV AIDS. 2017 Jan;12(1):47–56.

2. Bernard P, Antonicelli F. Bullous pemphigoid: a review of its diagnosis, associations and treatment. Am J Clin Dermatol. 2017 Aug;18(4):513–528.

3. Ghafar MZAA, Miptah HN, O’Caoimh R. Cognitive screening instruments identify vascular cognitive impairment: A systematic review. Int J Geriatr Psychiatry. 2019 Aug;34(8):1114-1127. doi: 10.1002/gps.5136. Epub 2019 May 16.

4. Tourlaki A, Genovese G, Guanziroli E, Scoppio BM, Berti E, Brambilla L. Autoimmune bullous diseases in non-HIV Kaposi’s sarcoma: a retrospective study in a large cohort of patients. J Eur Acad Dermatol Venereol. 2018 Oct;32(10):1777–1783.

5. Phavixay L, Raynolds D, Simman R. Non AIDS Kaposi’s sarcoma leading to lower extremities wounds, case presentations and discussion. J Am Coll Clin Wound Spec. 2013 Jan 19;4(1):13–15.

6. Cesarman E, Damania B, Krown SE, Martin J, Bower M, Whitby D. Kaposi sarcoma. Nat Rev Dis Primers. 2019 Jan 31;5(1):9.

8. Tilley C, Lipson J, Ramos M. Palliative wound care for malignant fungating wounds: holistic considerations at end-of-life. Nurs Clin North Am. 2016 Sep;51(3):513–531.

9. Probst S, Arber A, Faithfull S. 2013 Malignant fungating wounds: the meaning of living in an unbounded body. Eur J Oncol Nurs. 2013 Feb;17(1):38–45.

10. Probst S, Arber A, Trojan A, Faithfull S. Coping with an exulcerated breast carcinoma: an interpretative phenomenological study. J Wound Care. 2013 Jul;22(7):352–354, 356–358, 360.

7. Kluger N, Mandelin J, Santti K, Jeskanen L, Nuutinen P. Bullous pemphigoid triggered by radiotherapy for breast cancer. Presse Med. 2017 Jan;46(1):128–130.

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Symposium A Delivering quality patient-focused wound care in extraordinary times: can advanced dressings make a difference?

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– Learn about new and clinically relevant solutions for pressure ulcer, skin tear and venous leg ulcer therapy – Discover our new product area featuring oxygen therapy, the Exufiber® range and negative pressure wound therapy (NPWT)

Symposium B Dressings play a role in preventing surgical wound complications - or don’t they?

Nov 19th; 15.30 – 16.30 GMT Speakers: Karen Ousey, Kylie Sandy-Hodgetts and Philippe Van Overschelde

– Book meetings or use the live chat to talk to our booth staff – Learn more about what’s new at Mölnlycke® Talks Online and Mölnlycke® Advantage

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The Mölnlycke and Exufiber, names and logotypes are registered globally to one or more of the Mölnlycke Health Care group of companies. © 2020 Mölnlycke Health Care AB. All rights reserved. HQIM002171

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DOI: 10.35279/jewma202011.04

Geert Vinck, BSN, Woun Care Nurse1

Wound care within Flemish residential care centres: An update In Belgium, the average age of inhabitants is still rising, due to better life expectancy and because of an increase in the relative proportion of older people in society. As a result, the number of chronic disorders and comorbidities is increasing as well.

The aim of this study was to acquire an overview of the wounds and wound care present in residential care centres.

Keyword s:

wound care; prevalence; nursing knowledge and education; wound care protocol; residential care centre

ABSTRACT Objectives To obtain prevalence figures for the different wound types present in residential care centres (RCCs), to investigate nurses’ prior education in wound care and to find out if RCCs have wound care protocols.

Background The number of RCC residents is rising due to our aging society. There are almost no figures available on the prevalence of wounds in RCCs and the level of education of the care providers employed in these centres.

Method An observational retrospective cohort study was conducted during the period 2012–2014 in 16 RCCs (on 1,238 residents). Residents were screened for the presence of wounds, and if a wound was present, additional clinical data were collected. On the obtained data, descriptive statistics, a t-test and/or a chisquare test were performed.

Results A general wound prevalence of 11% was found. Pressure ulcers were the largest group with a prevalence of 36%, followed by skin tears (17%) and venous ulcers (8%). Within the RCCs surveyed, only 37% of the care providers were nurses. Of the interviewed nurses, 8% possessed the certificate of Reference Nurse in Wound Care. Of the nurses, 90% indicated that they needed additional training in wound care, but only 48.7% received the opportunity for additional training from their employers. Of the RCCs studied, 47% had wound care protocols.

Conclusion Further research into wound prevalence and nurses’ knowledge of wound care is necessary. Employers have an important role to play in keeping nurses’ knowledge of wound care up to date and in ensuring that their institutions possess wound care protocols.

Key messages - The average age of Belgian citizens is rising. As a result, the number of chronic disorders and co- morbidities are increasing as well.

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1. Algemeen Ziekenhuis Klina, Brasschaat, Belgium

Correspondence: geert.vinck@klina.be · Conflicts of Interest: None

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- In 2007, 8% of people aged over 65 and 42% of those aged over 85 lived in residential care centres.

Of these residents, 11.2% suffered from 1 or more wounds.

- The aim of the current study was (a) to acquire an overview of the wounds present in residential care centres (RCCs) and obtain prevalence figures, (b) to investigate nurses’ prior education in wound care and (c) to discover whether RCCs have wound care protocols.

n

Results In general, a wound prevalence of 11% was found.

n 90% of the nurses indicated that they needed additional training in wound care, but only 48.7% of them received the opportunity from their employers. n 47% of the RCCs in this study had wound care protocols.

INTRODUCTION This article presents results from a survey measuring the prevalence of different wounds in Flemish residential care centres (RCCs). It will also give an overview of nurses’ prior education in wound care and the presence of wound care protocols in these centres.

Wound prevalence In Belgium, the average age of inhabitants is still rising, due to better life expectancy and because of an increase in the relative proportion of older people in society. When there are more elderly people in a population, more chronic disorders and co-morbidities are also observed. This also means that more people are in need of receiving help from healthcare providers. In 2007, 8% of people older than 65 and 42% of those older than 85 lived in residential care centres.1,2,3 Of these, 11.2% had to deal with 1 or more wounds, with skin tears, venous leg ulcers and decubitus and diabetic foot ulcers being the most common.4 Limited data are available on wound care and the prevalence of wounds in Flemish RCCs because, currently, there are only two publications available on this subject: L. Gryson’s 2011 study4 on the preva-lence of wounds in Flemish hospitals and RCCs and a study by P. Capellier in 20145 about the prevention of diabetic foot ulcers in RCCs by Certified Nursing Assistants.

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To provide adequate wound care, it is necessary that nurses possess sufficient knowledge regarding such care, especially because, in Belgium, nurses are respon-sible for the daily care of wounds. We all know that good wound care starts with good observation of the wound. In recent years, there has been an evolution in the con-cepts regarding this observation. A good example is the TIME concept. But do nurses know about this and other such concepts? At the moment, there are no studies on this that concern nurses in Flemish RCCs. IMPORTANCE OF WOUND CARE PROTOCOLS Wound care protocols ensure that healthcare providers provide cohesive and consistent wound care therapy to the patient. They also lead to a better patient outcome.6 Currently, there are no data available about the presence of wound care protocols in Flemish RCCs. Because of this, research with more recent data on the prevalence of wounds, prior education and the availability of wound care protocols in Flemish RCCs is necessary.

OBJECTIVE The aims of this study were (a) to obtain an overview of the wounds present in residen-tial care centres (RCCs) and to obtain prevalence figures, (b) to investigate nurses’ prior education in wound care and (c) to find out if RCCs have wound care protocols.

METHOD Design This observational retrospective cohort study analysed the results from observations made by students on the Wound Care, Stoma Care and Tissue Repair postgraduate programmes during the period 2012– 2014. These students had to observe the wounds and wound care of inhabitants of Flemish RCCs and collect data from patient records, including those on comorbidities, types of wounds and wound treatment.

In addition, they gathered information about the availability of wound care protocols, the decision– making process regarding wound classification and wound therapy and the staff of healthcare providers, including their prior education level in wound care. The students all used the same questionnaire to gather this information.

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Population The population in this study was the 42,151 residents being managed in Flemish RCCs in 2011 and their healthcare providers.

Sample size A total of 17 different RCCs participated in the study.

A minimum sample size of 653 residents was necessary to work with a confidence level of 99%. With a response from 1,238 residents, our sample size was sufficient.

there was a significant difference between the averages of the studied groups of the population.

Ethical issues We received the approval of the local ethical committee to use the data from the student reports for this observational retrospective cohort study. All observations respected the 2013 ethical guidelines of the Declaration of Helsinki.

RESULTS Inclusion and exclusion criteria In order to be included, the obtained data had to come from an RCC located in Flanders, Belgium.

The data also had to be obtained with the explicit permission of the management, staff and residents of these centres. If the data did not meet these criteria, they were not included in the study.

Study protocol In the period 2012–2014, students of postgraduate Wound Care, Stoma Care and Tissue Repair carried out a survey, which included the management of RCCs and their employed nurses. Furthermore, all residents were observed for the presence of wounds and the wound care that they received. All collected data were anonymised using a study code. These anonymised data were used for the current study. This means that these data were processed and statistically analysed by someone who did not participate in the observations and surveys.

Data analysis The data analysis was carried out using Microsoft Excel®. Descriptive statistics, the student t–test and the chisquare test were used to determine whether

General A total of 17 different RCCs participated in the study.

One Dutch RCC was excluded as it did not meet the inclusion criteria. Of the included RCCs, 45% were public and 55% were private. Of the RCCs, 6 (4 private, 2 public) accommodated more than 100 residents. The smallest RCC accommodated 38 residents, and the largest had 217 residents.

Data about the employees In Belgium, there are two major care providers in the residential care setting: nurses, who obtain a nursing degree after four years of study (a Bachelor’s Degree in Nursing) or three years of study (a Graduate Nurse), and Certified Nursing Assistants, who receive a certificate after one year of study. Belgian law clearly describes which tasks related to wound care a Certified Nursing Assistant may perform under the supervision of a nurse, for example, the hygienic care of a healed stoma, helping a resident with eating and drinking and taking precautionary actions against pressure ulcers. A nurse will instruct the Certified Nursing Assistants and take care of other nursing procedures, like wound care, the stoma care of non–healed stomas

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Do you get, as a nurse, sufficient support for developing your knowledge regarding wound care?

None

6.5%

Insufficient

44.9%

Sufficient More than sufficient

46.7% 1.9% 0.0% 5.0%

10.0% 15.0% 20.0% 25.0% 30.0% 35.0% 40.0% 45.0%

Figure 1. Do nurses get sufficient support for developing their knowledge regarding wound care?

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and the debridement of pressure ulcers.

In the 16 RCCs, 570 people took part in the daily care of the residents. Of these, 37% had a nursing degree and the remaining 63% were Certified Nursing Assistants. This means that, on average, 19 nurses (minimum 8, maximum 35) and 32 Certified Nursing Assistants (minimum 12, maximum 51) work in an RCC. Based on the deployment of staff per resident, it is possible to notice a difference between private and public operated RCCs. Private RCCs employ an average of 0.76 care providers per inhabitant, whereas public RCCs employ only 0.53 care providers per inhabitant. However, this is not a significant difference (t(4) = 0.73, p = 0.51). The nurses interviewed were on average 44 years old (min.

23 years, max. 62 years), and 87% were female and 13% male. The majority, 62.3%, had a Graduate Nursing diploma, 35.2% had a Bachelor’s Degree in Nursing and 2.5% also had a master’s degree or licentiate certificate. It was mainly male nurses (56%) who had a bachelor’s degree. The female nurses had a bachelor’s degree in 32% of the cases.

Nursing knowledge regarding wound care Of the nurses surveyed, 8% possessed the certificate of Reference Nurse in Wound Care. In Belgium, nurses can receive this certificate after completing a 40–hour course on wound care. When asked about the need for training or further training in wound care, only 10.1% of the nurses indicated that they had sufficient knowledge. Of the nurses in need of ad-

ditional training or education regarding wound care, 6.5% were not given the opportunity to retrain by their employers. Another 44.9% indicated that they were insufficiently able to develop their knowledge regarding wound care, as shown in Figure 1.

To get an impression of whether nurses are up to date with the newest wound observation tools, they were asked if they were familiar with concepts like TIME, TIME DHN and MEASURE. Only 36% of the interviewed nurses were familiar with the TIME concept, and 12% were also familiar with the TIME DHN concept. Another 11% did not possess knowledge of TIME but were familiar with MEASURE. This means that less than 50% of the nurses are knowledgeable about the latest wound observation tools. The amount of work experience possessed by the nurses was not investigated.

Presence wound care protocols Of the 17 RCCs, 8 (47%) had wound care protocols.

Only in three of them was the wound care nurse involved in drafting the protocol. For the others, it was mainly a doctor in collaboration with a nurse without additional training in wound care (4 RCCs) or the care coordinator (1 RCC) who had created the protocol. It is remark-able that all private RCCs had wound care protocols available in their institutions, but there was only one public RCC that had a wound care protocol available. Deviations in the protocol were mainly assigned by a doctor.

GENERAL (Number vs % of a total of 153 residents with a wound)

MALE (Number vs % of a total of 43 men with a wound)

FEMALE (Number vs % of a total of 110 women with a wound)

Medication

57 (37%)

13 (30%)

44 (40%)

Diabetes

37 (24%)

15 (35%)

22 (20%)

Rheumatism

9 (6%)

0 (0%)

9 (8%)

Deep vein thrombosis

13 (8%

4 (9%)

9 (8%)

Varicose veins

13 (8%)

2 (5%)

11 (10%)

Atherosclerosis

34 (22%)

12 (28%)

22 (20%)

Hypertension

32 (21%)

6 (14%)

26 (24%

Arthritis

12 (8%)

0 (0%)

12 (11%)

Smoking

5 (3%)

1 (2%)

4 (4%)

Table 1. Overview regarding the medical history of the residents with an active wound

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Prevalence of specific wound types in Flemish residential care centres Other

1.3%

Traumatic wounds

1.1%

Oncologic wounds Burns

0.4% 0.2%

Skin tears

2.0%

Pressure ulcers

4.2%

Diabetic

0.5%

Foot Mixed venous/arterial ulcers

0.6% 0.2%

Arterial ulcers

0,9%

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

Figure 2. Prevalence of specific wound types in Flemish residential care centres

Data regarding residents with a wound On average, the residents had already spent 3.5 years (min. 6 days, max. 23.5 years) in an RCC at the time of the observation. The average age was 85.51 years (min. 59 years, max. 101 years, median 86.5 years).

Of the 153 residents with a wound, 43 were male, and 110 were female. The men were 83.18 years old on aver-age (min. 59 years, max. 93 years), and the women were 86.43 years old (min. 60 years, max.

101 years). This difference in age is statistically significant (t(70) = -4.20, p < 0.01). Most residents also had one or more disorders in their medical histories that have a negative influence on wound healing or put the resident at high risk of obtaining a wound.

Table 1 shows an overview of these risk factors. It is remarkable that women with a wound show significantly more rheumatism (t(108) = -3.12, p < 0.01) or arthritis (t(108) = -3.66, p < 0.01) in their medical histories than men .

Wound prevalence In general, a prevalence rate of 11% was obtained.

The highest prevalence rate obtained for an RCC was 26%, and the lowest was 1%. Furthermore, an

average of 5% of the residents in private RCCs had an active wound. In public RCCs, an average of 14% was obtained, which is, however, a non–significant difference (t(4) = -1.28, p = 0.27). RCCs with more than 100 residents had lower prevalence figures than those with a lower number of residents (3.5% versus 16.5%). Again, this was not statistically significant (t(3) = 2.29, p = 0.11), but it could be a subject for further investiga-tion. Finally, a comparison was also made between wound prevalence in RCCs with and without wound care protocols. This also yielded no significant difference (t(3) = -0.32, p = 0.77).

Prevalence of specific wound types Decubitus ulcers (category 2 or more; 38%), together with skin tears (18%), repre-sent more than 50% of the wounds in RCCs, closely followed by venous leg ulcers (8%). As shown in Figure 2, this results in a prevalence of 4.2% for pressure ulcers (category 2 or more), 2% for skin tears and 0.9% for venous leg ulcers. Several caregivers were involved in diagnosing the type of wound, but with 65% of the wounds, it was the nurse who made the diagnosis. For 11%

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of the wounds, it was the general practitioner, and for 14% of them, it was the nurse together with the general practitioner who made the diagnosis. In all other cases, it was the physician specialist who made the diagnosis. It should be noted that, in view of the population, it was striking that a geriatrician did not make any wound diagnoses, but it was mainly medical specialists from other disciplines (orthopaedic surgeons, dermatologists, vascular surgeons, oncologists) who made them. Whether these medical specialists had completed a specialised course regarding wound care was not observed.

Data regarding the provided wound care This research also investigated who prescribes and adjusts the treatment of a wound. A virtually even distribution between general practitioners (30%), nurses (37%) and wound care nurses (27%) was noticeable. As far as the adjustment of wound care therapy is concerned, the distribution is slightly different. In this situation, it is mainly the nurse (41%) and the wound care nurse (40%) who adjust the wound policy. In all other cases, it is mainly the general practitioner who adjusts the wound policy.

It is noticeable that it was rarely indicated that the wound policy was changed by a multi-disciplinary team. It was a joint decision made by the general practitioner and a nurse that scored the best (15%).

Furthermore, it was remarkable that nurses took care of the wounds on a daily basis in 80% of the cases observed, despite the fact that they used bandages that can remain on the wound for several days. It turned out that one in five bandages that were made to remain on the wound site for several days (foam bandages, alginates, hydrocapillary bandages) were replaced daily.

DISCUSSION The role of education regarding care providers Caregivers and, more specifically, nurses, play a crucial role in the treatment and observation of wounds.

Doctors also rely on the observations of the nurses to adjust or set up possible wound policies. It is therefore crucial that correct observations and conclusions are made. Within the literature, it is possible to find a number of studies that look at the knowledge of nurses. However, they always look at the knowledge of a certain type of wound and not at general knowledge.

In their research from 2014, Zarchi7 and his research team also stated that patients with chronic wounds benefit from being treated by specialised staff, since

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wound care is not a priority for other healthcare providers. They also noted that nurses gained the most information about wound care by working together with others who possess a large knowledge of it. Following additional training courses has a lower yield.

It should be noted, however, that there is great diversity in further training, varying from a few hours to several days, which means that the effect of a specific type of further training is levelled out. The number of years of work experience of nurses is also often associated with more knowledge. However, if there is no support from the organisation for gathering and retaining knowledge and the nurse does not take any initiatives himself/herself, more work experience does not mean that more knowledge is available from the care provider.

Wound prevalence It is estimated that about 1% to 2% of the population in developed countries will be confronted with a chronic or nonâ&#x20AC;&#x201C;healing wound in their lives.8 Diabetic foot ulcers, venous leg ulcers and pressure ulcers form the majority of these chronic wounds.9 According to a study by BEFEZO, the Belgian Federation for Certified Nursing Assistants, about 2% of residential care residents suffer from diabetic foot ulcers.5 This is in line with the estimation made by Pataky10 in 2007, in which he stated that about 5% of diabetic patients aged over 65 had a preâ&#x20AC;&#x201C;diabetic foot injury. However, more accurate figures on the prevalence of diabetic foot ulcers in RCCs are lacking.

Graham et al. (2003) teach us, based on their systematic review11, that ulcers of the lower legs have a prevalence of between 0.6% and 3.6% and that these figures increase with age. As a result, we can expect a higher prevalence among our residents because of their ages. For example, Srinivasaiah and his colleagues report, in their 2007 study12, that, in North East England, there is a prevalence of 37.6% for venous leg ulcers, as well as one of 12.4% for arterial ulcers and mixed arteriovenous ulcers alike.

In Australia, we also see comparable figures for elderly populations, in, for example, a prevalence of 13%.13 It can generally be stated that, within the adult population, there is a prevalence of 0.5% to 1.5% with regard to venous leg ulcers.14 The difference in these figures may possibly be explained by the education given to the patient regarding venous leg ulcers. Gonzalez et al. proved in 2017, with their research15, that patient education is an important

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factor in the prevention of venous ulcers. In addition, the difference can also be explained by means of the included population. The higher the age of and the more women in the population, the higher the prevalence of ulcers.16 In addition, the figure itself can cause confusion, as some studies show a prevalence per 1000 persons and others, a prevalence figure for their entire study population. However, this is not always clearly noted in the studies.17,18 In addition, studies often do not distinguish diabetic foot ulcers, venous leg and/or arterial ulcers, given that these are all in the same region, namely the lower leg and foot.

are remarkably higher. They usually vary between 5.6% and 50%.33,34,35 The measured figure of 0.5% is therefore considerably lower than the 30% for IAD cate-gory one and the 6% for IAD category two that were registered in a study by the University of Ghent.36 In Austria, Kottner et al.37 noted a prevalence of 3.1% in nursing homes, while in the Netherlands they noted one of 6.5%, and a German study19 noted a prevalence of 35.4%. In 2006, Bliss et al.38 reported a prevalence of 6% for Germany.

However, further research is needed to explain these differences.

The prevalence of decubitus ulcers varies from study to study and from country to country. For example, in the literature, it is possible to find prevalences of 9%19, 8.8% 20 and 13.9%21 for Germany. Davis and Caseby22 reported a prevalence of 45% for Canadian retirement homes in 2001, while Woodbury and Houghton23 recorded a prevalence of 29.9%. For the United States of America, Vangilder et al.24 found a prevalence of 14.4% in 2008, which is similar to the 13.7% that Temkin–Greener25 and her team found in 2012, but well below the 23% that Bauer et al.26 found in their retrospective study in the period 2008–2012. In Italy, a prevalence of 27% was determined by Capon et al. (2007)27 and one of 29.2% in the Netherlands.28 Van Leen et al.29, however, recorded a prevalence of 4% in 2014. For Denmark, prevalences of 15% and 25% were found30, while in Finland, there was one of 15.1%31, and in North East England, a prevalence of 17.4% was recorded.12 The big differences between these prevalence figures can be due to the way the data are collected. For example, care providers in one study must provide data themselves to the researchers, while in other studies, research nurses are called in to collect the data. In addition, not all categories of pressure ulcers were included in the studies, so a distorted image can also be obtained.32 Another possibility that can explain the difference in prevalence is the organisation and cohesion of the teams of care providers.

Temkin–Greener et al.25 showed that the occurrence of pressure ulcers in nursing homes with teams with strong mutual cohesion is significantly lower than in those with teams where this is less. The way in which prevention is carried out can also be a cause of these differences.20

Data about the prevalence of oncological ulcers are rare. In the 2010 national guidelines on ‘Oncological Ulcers’ of the Comprehensive Cancer Centre of The Netherlands39, skin ulcers are reported to occur in 0.7% to 9% of all patients with cancer, especially breast carcinomas, tumours in the head and neck area, gynaecological tumours and rectal carcinoma.

There are no figures on how often oncological wounds occur in RCCs. Finally, it must also be considered whether a correct distinction has been made between oncological wounds (wounds caused by oncological treatment) and oncological ulcers (wounds caused by growth of the primary tumour or metastasis); a distinction between these two is often not made in practice.

For incontinence–associated dermatitis (IAD), a prevalence of 0.5% was measured within this study.

In the literature, however, the prevalence figures

As far as burns are concerned, no information can be found about the prevalence of burn injuries in RCCs. However, it is stated in a study by Brusselaers et al.40 that elderly people make up 10% to 16% of patients with severe burns. These burns, however, usually occur during activities at home or as a result of an accident during relaxation activities; as a result, this still does not give a picture of the development of burns in our RCC residents.

Hahnel et al.19 found a prevalence of 6.3% regarding skin tears in Berlin RCCs in 2017, while Skiveren, Wahlers and Bermark30 registered a prevalence of 4.6% in 2017 for a Danish RCC. They also showed that the prevalence of skin tears was much higher among residents who had already had a skin tear in the past compared to those who had never had a skin tear (83.3% compared with 16.4%). In 2014, a prevalence of 3.9% was observed in a Japanese study.41 For Australia, the prevalence figures vary widely in studies, ranging from 5.5% to 9%.13,30 However, other prevalence figures regarding skin tears are lacking. The big differences are often dependent

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on the study design: which population is examined (age) and whether all residents with a skin tear are included or only those with a skin tear on the lower limbs.

Limitations The data used in this study are based on the answers obtained from a questionnaire that was completed by the interviewed nurses or by postgraduate students of Wound Care, Stoma Care and Tissue Repair if it concerned the data of the residents. Regarding the wound care protocols, only the presence of the protocol was tested. Whether these are up to date remains unknown. In addition, data were only collected concerning residents with a wound and not from all residents. Also, the definitions of the different wound types were determined by the students without prior agreement. Finally, there are also diagnoses made by nurses, where the advice of a doctor is not unimportant, i.e. differential diagnoses of venous, arterial or mixed–venous ulcers.

CONCLUSION In general, it can be stated that research into wound prevalence and the knowledge of care providers regarding wound care within Flemish RCCs is appropriate and this with a protocol that clearly states the definitions of the wound types used to classify the observed wounds. After all, the results obtained in this study are difficult to compare with prevalence figures from the past or with international figures because there are strong differences or uncertainties in the included population, the education level of the care providers and the definition used for a certain type of wound. The level of education of the persons who screened the residents also has an influence on the obtained information. Nevertheless, it can be stated that with a prevalence rate of 11%, the incidence of wounds within Flemish RCCs is comparable to international figures. Larger RCCs score better than smaller ones in this area, but this difference could not be retained as significant. Pressure ulcers, with a prevalence of 4.2%, are by far the most common wounds in RCCs, closely followed by skin tears (2%), ulcers (1.7%) and diabetic foot wounds (0.5%). Because, within this study, only clinical data were collected if residents had an active wound, it was not possible to present risk factors. However, this study showed that there was a significant difference between men and women regarding the presence of rheumatism and arthritis in their medical histories.

In terms of staffing, certified nursing assistants make

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up the largest part of the teams in RCCs. Employed nurses mainly hold the graduate nursing diploma.

Bachelor nurses are in the minority, and nurses with a master’s degree are rare. Of the 122 nurses surveyed, 16 of them were wound care nurses. This study also showed that 90% of the questioned nurses indicated that they need additional training regarding wound care. Only 48% of these nurses got the opportunity from their employers to fulfil this need. The employer therefore has a significant influence on the further training processes of its employees. Support from the employer is indispensable because the amount of work experience does not provide the certainty of more knowledge. Less than half of the RCCs surveyed had wound care protocols. Private RCCs scored better here than public ones. Unfortunately, only a minority (37%) had a wound care nurse involved in drafting these protocols. It is therefore advisable that all institutions work on drafting a wound care protocol, preferably in a multidisciplinary way involving wound care nurses.

IMPLICATIONS FOR CLINICAL PRACTICE - The employer has a significant influence on the further training process of its employees.

- Less than half of the RCCs surveyed had a wound care protocol. It is therefore advisable that all institutions work on drafting a wound care protocol, preferably in a multidisciplinary way involving wound care nurses.

- It is advisable that healthcare providers pay more attention to interprofessional collaboration regarding wound management.

FURTHER RESEARCH - Further research into wound prevalence and the knowledge of care providers regarding wound care within Flemish RCCs is appropriate and this with a protocol that clearly states the definitions of the wound types used to classify the observed wounds.

ACKNOWLEDGEMENT Special thanks to Evelien Touriany, wound care coordinator of the Queen Astrid Military Hospital, Neder–over–Heembeek, Belgium for her contribution to this study.

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REFERENCES 1. Charlot V, Cobbaut N, De Mets J, Hinnekint B, Lambert M. Het Woonzorgcen-trum in de 21ste Eeuw: Een Gezellige Woonomgeving. [The Residential Care Center in the 21st Century: a Cozy Living Environment.]

Brussels: Koning Boudewijnstichting; 2009.

2. Regueras N, Verniest R. Vergrijzing en Ouderenzorg in beeld – deel1. [Aging and Aging Care in the Picture – Part 1. CM, 2014.

3. Van den Bosch K, Willemé P, Geerts J, Breda J, Peeters S, Van de Sande S, et al. Toekomstige Behoefte aan Residentiële Ouderenzorg in België: Pro-jecties 2011–2025.

[Future Need for Residential Elderly Care in Belgium: Projections 2011–2025] Federaal Kenniscentrum voor de gezondheid-szorg 2011, Brussels.

4. Gryson L. Prevalentie van Wonden in Ziekenhuizen en Woonzorgcentra in Vlaanderen. [Prevalence of Wounds in Hospitals and Residential Care Centers in Flanders.]

Nursing 2011 (April); 2–5.

15. Gonzalez A. The Effect of a Patient Education Intervention on Knowledge and Venous Ulcer Recurrence: Results of a Prospective Intervention and Retrospective Analysis. Ostomy Wound Manage 2017; 63(6): 16–28.

30. Skiveren J, Wahlers B, Bermark S. Prevalence of Skin Tears in the Extremi-ties Among Elderly Residents at a Nursing Home in Denmark. J Wound Care 2017; 26(2): S32– S36.

16. O’Brien J, Grace P, Burke P. Prevalence and Aetiology of leg Ulcers in Ire-land. Ir J Med Sci 2000; 169: 110–112.

31. Muurinen S, Soini H, Pitkälä K. Commentary on Tannen A, Dassen T, Halfens R (2008) Differences in Prevalence of Pressure Ulcers Between the Netherlands and Germany – Associations Between Risk, Prevention and Occurrence of Pressure Ulcers in Hospitals and Nursing Homes. J Clin Nurs 2008; 18: 304–311.

17. Pina E, Furtado K, Franks P, Mofatt C. Leg Ulceration in Portugal: Preva-lence and Clinical History. Eur J Vasc Endovasc Surg 2005; 29: 549–553.

18. Bergqvist D, Lindholm C, Nelzén O. Chronic Leg Ulcers: The Impact of Ven-ous Disease. J Vasc Surg 1999; 29: 752–755.

19. Hahnel E, Blume–Peytavi U, Trojahn C, Kottner J. Associations Between Skin Barrier Characteristics, Skin Conditions and Health of Aged Nursing Home Residents: A Multi–Center Prevalence and Correlational Study. BMC Geriatr 2017; 17: 263–275.

5. Capellier P. Preventie van Diabetische Voet door Zorgkundigen Binnen Woonzorgcentra. [Diabetic Foot Prevention by Nursing Assistents Within Resi-dential Care Centers.] Eindwerk, VIVES Roeselare; 2014.

20. Tannen A, Dassen T, Halfens R. Differences in Prevalence of Pressure Ul-cers Between the Netherlands and Germany – Associations Between Risk, Prevention and Occurrence of Pressure Ulcers in Hospitals and Nursing Homes. J Clin Nurs 2008; 17(9): 1237–1244.

6. Hensen P, Huong–Lan Ma, Luger TA, Roder N, Steinhoff M. Pathway Man-agement in Ambulatory Wound Care: Defining Local Standards for Quality Improvement and Interprofessional Care. Intl Wound J 2005; 2(2): 104–111.

21. Lahmann N, Halfens R, Dassen T. Pressure Ulcers in German Nursing Homes and Acute Care Hospitals: Prevalence, Frequency and Ulcer Characteristics. Ostomy Wound Manage 2006; 52: 20–33.

7. Zarchi K, Latif S, Haugaard V, Hjalager I, Jemec G. Significant Differences in Nurses’ Knowledge of Basic Wound Management – Implications for Treatment. Acta Derm Venereol 2014; 94: 403–407.

8. Rondas A, Schols J, Stobberingh E, Halfens R. Prevalence of Chronic Wounds and Structural Quality Indicators of Chronic Wound Care in Dutch Nursing Homes. Int Wound J 2015; 12: 630–635.

9. Gupta S, Andersen C, Black J, de Leon J, Fife C, Lantis II J, et al. Manage-ment of Chronic Wounds: Diagnosis, Preparation, Treatment and Follow–up. Wounds 2017; 29(9 suppl): S19–S36.

10. Pataky Z, Vischer U. Diabetic Foot Disease in the Elderly.

Diabetes Metab 2007; 33: S56–S65.

11. Graham I, Harrison M, Nelson A, Lorimer K, Fisher A. Prevalence of Lower–Limb Ulceration: A Systematic Review of Prevalence Studies. Adv Skin Wound Care 2003; 16: 305–316.

12. Srinivasaiah N, Dugdall H, Barett S, Drew P. A Point Prevalence Survey of Wounds in North East England. J Wound Care 2007; 16(10): 413–419.

13. Walker J, Cullen M, Chambers H, Mitchell E, Steers N, Khalil H.Identifying Wound Prevalence Using the Mobile Wound Care Program. Int Wound J 2014; 11: 319–325.

14. Abbade L, Lastoria S, de Almeida Rollo H, Ometto Stolf H. A Socio Demographic, Clinical Study of Patients With Venous Ulcers. Int J Dermatol 2005; 44: 989–992.

22. Davis C, Caseby N. Prevalence and Incidence Studies of Pressure Ulcers in two Long–Term Care Facilities in Canada. Ostomy Wound Manage 2001; 47: 28–34.

23. Woodbury M, Houghton P. Prevalence of Pressure Ulcers in Canadian Healthcare Settings. Ostomy Wound Manage 2004; 50: 22–38.

24. Vangilder C, Macfarlane G, Meyer S. Results of Nine International Pressure Ulcer Prevalence Surveys: 1989 to 2005. Ostomy Wound Manage 2008; 54: 40–54.

25. Temkin–Greener H, Cai S, Zheng N, Zhao H, Mukamel D. Nursing Home Work Environment and the Risk of Pressure Ulcers and Incontinence. Health Serv Res 2012; 47(3): 1179–1200.

26. Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States’ Inpatient Population From 2008 to 2012: Results of a Retrospec-tive Nationwide Study. Ostomy Wound Manage 2016; 62(11): 30–38.

27. Capon A, Pavoni N, Mastromattei A, Di Lallo D. Pressure Ulcer Risk in Long–Term Units: Prevalence and Associated Factors. J Adv Nurs 2007; 58(3): 263–272.

28. Tannen A, Bours G, Halfens R, Dassen T. A Comparison of Pressure Ulcer Prevalence Rates in Nursing Homes in the Netherlands and Germany, Adjusted for Population Characteristics. Res Nurs Health 2006; 29: 588–596.

29. van Leen M, Schols J, Hovius S, Halfens R. A Secondary Analysis of Longi-tudinal Prevalence Data to Determine the use of Pressure Ulcer Prevent-ive Measures in Dutch Nursing Homes, 2005–2014. Ostomy Wound Man-age 2017; 63(9): 10–20.

32. Moore Z, Cowman S. Pressure Ulcer Prevalence and Prevention Practices in Care of the Older Person in the Republic of Ireland. J Clin Nurs 2011; 21: 362–371.

33. Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A Systematic Re-view and Meta–Analysis of Incontinence–Associated Dermatitis, Inconti-nence and Moisture as Risk Factors for Pressure Ulcer Development.

Res Nurs Health 2014; 37: 204–218.

34. Beeckman D. A Decade of Research on Incontinence–Associated Dematitis (IAD): Evidence, Knowledge Gaps and Next Steps. J Tissue Viability 2017; 26: 47–56.

35. Holroyd S. Incontinence–Associated Dermatitis: Identification, Prevention and Care. Br J Nurs 2015; 24(9): S37–S43.

36. Van Damme N, Van den Bussche K, De Meyer D, Van Hecke A, Verhaeghe S, Beeckman D. Independent Risk Factors for the Development of Skin Erosion due to Incontinence (Incontinence–Associated Dermatitis Cate-gory 2) in Nursing Home Residents: Results From a Multivariate Binary Regression Analysis. Int Wound J 2017; 14: 801–810.

37. Kottner J, Blume–Peytavi U, Lohrmann C, Halfens R. Associations Between Individual Characteristics and Incontinence–Associated Dermatitis: A Secondary Data Analysis of a Multi–Centre Prevalence Study. Int J Nurs Stud 2014; 51: 1373–1380.

38. Bliss D, Savik K, Harms S, Fan Q, Wyman J. Prevalence and Correlates of Perineal Dermatitis in Nursing Home Residents. Nurs Res 2006; 55(4): 243–251.

39. Lintz–Luidens H, de Graeff A, Scheerhoorn–Nooij A, Noyen JJM, Krol RJA, Löwik M, et al. Richtlijn Oncologische Ulcera,[Guideline Oncologic Ulcers] Integraal Kenniscentrum Midden–Nederland, 2010.

40. Brusselaers N, Monstrey S, Vogelaers D, Hoste E, Blot S. Severe Burn Injury in Europe: A Systematic Review of the Incidence, Etiology, Morbidity and Mortality. Crit Care 2010; 14(5): R188.

41. Koyano Y, Nakagami G, Iizaka S, Minematsu T, Noguchi H, Tamai N, et al. Explor-ing the Prevalence of Skin Tears and Skin Properties Related to Skin Tears in Elderly Patients at a Long–Term Medical Facility in Japan. Int Wound J 2016; 13: 189–197.

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© Thomas M. Barwick INC – Getty Images MEDICAL DEVICE INDUSTRY CONSULTING Americas Europe Asia

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DOI: 10.35279/jewma202011.05

Mary E. O’Hara1

Consent to treatment Seeking a person’s consent to treatment is, not only a legal obligation, but also enmeshed with respecting the person’s autonomy and dignity for self-determination. This article discusses the evolving concept of consent among patients requiring wound care.

Keyword s:

consent; valid; informed; voluntary; capacity; human rights

ABSTRACT Background Patients’ valid consent to treatment must be gathered prior to providing treatment to ensure the protection of a person’s rights. This article discusses the key components of a valid consent to treatment, as well as different forms of consent. Two case scenarios also consider pertinent consent issues related to wound care provision. Using a human-rights-based approach1, the Fairness, Respect, Equality, Dignity and Autonomy (FREDA) principles2, linked to the Convention of the Rights of People with Disabilities (2006)3, provide a useful guiding framework and resource for clinical decision-making.

Key messages 1. Gaining valid consent to treatment and respecting a person’s right to self-determination.

2. Ensuring consent is not devalued by the routinised provision of care procedures.

3. The value of consent is more than gaining per mission to carry out a procedure. It is a process that respects a person’s autonomy and rights. This process is person-centred and includes service users as active participants in their own health care decision-making.

Is gaining consent a tick box exercise?

Seeking a person’s consent to treatment is, not only a legal obligation, but also enmeshed with respecting the person’s autonomy and dignity for self-determination. On the 72nd anniversary of the United Nations Universal Declaration of Human Rights (UDHR) (1948)4, it is useful to consider the basic ethical and legal principle of ‘consent to treatment’ and its implications for clinical practice. Associated with both civil and criminal law, consent is acknowledged by the United Nations Committee on Economic, Social and Cultural Rights (CESCR)5 as a core concept, obliging states to support ‘people to make informed choices about their health’.1 Using case scenarios, this article discusses the evolving concept of consent among patients requiring wound care. This population may be considered vulnerable due to comorbidities, such as frailty and advanced age. Additionally, the procedure of gaining patient consent could be devalued or nullified because of the frequency or routinised provision of wound care.6 Therefore, gaining consent for a wound care procedure could become a perfunctory, bureaucratic matter, conducted as a ‘tick box’ exercise.

The Fairness, Respect, Equality, Dignity and Autonomy (FREDA) principles1 provide a humanrights-based approach and guiding framework for clinical care. These principles are linked to human rights legislation, including the European Union’s

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1. School of Nursing & Midwifery, National University of Ireland Galway, University Road, Galway, Ireland

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Charter of Fundamental Rights (CFR) (2000)7 and the United Nation’s Convention on the Rights of Persons with Disabilities (UN CRPD) (2006).3 In the case scenarios it examines, this research will use the FREDA principles to provide a useful aid and resource for considering whether elements of consent are met.2 There are three key elements to valid consent to treatment. Consent must be voluntary; it must be informed; and the person giving consent must have the mental capacity to do so.8 Consent must be voluntary People must give their consent of their own free will, without duress, coercion or undue influence.

Consent is specific to the particular procedure being planned, and any information given by the clinician relates to that procedure.8 The Right to Refuse Treatment: If people voluntarily give consent, they also have the right to voluntarily refuse to consent, withdraw their consent and change their minds. Refusing treatment may appear unusual, or even peculiar, to others, and, in some cases, it may lead to death. However, if the three components of a valid consent have been met, people reserve the right to make their own decisions regarding treatment.

Consent must be informed To give a valid consent, people must have the pertinent information to make informed decisions. When sufficient information is provided in an accessible, unbiased manner, clinicians have discharged their duties to disclose. However, difficulties can arise when clinicians are unsure of what is appropriate, pertinent information. Insufficient information provided in an inaccessible manner could be considered negligence and a failure of the clinicians to discharge their duties.9 In some extreme situations, this could give rise to a claim for battery. In recent years, the legal principle has evolved into the ‘reasonably prudent patient or patient-centred test.II This test is based on what a patient considers to be relevant, pertinent information, not merely on the information the clinician provides. However, an exception to this is ‘therapeutic privilege’.III In these circumstances, the clinician may not disclose information to a patient if it is believed that serious psychological harm would be incurred by that disclosure.

In a claim for negligence or battery, the people making the claim (plaintiffs) must prove that the information provided to them was insufficient or irrelevant

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and that the warnings given were inadequate, thereby damaging them.

Forms of consent Consent may be given in many forms, including orally or in writing. It can also be implied or explicit.

Both oral and written methods are valid for gaining consent. However, it may not always be straightforward to prove that oral consent was given. With written consent, there is a record of consent being gained.8 Implied Consent: If people visit a clinician, it could be implied that, in so doing, they consent to the clinician’s examination.8 Necessary consent: In urgent circumstances, where it may be impossible to gain consent prior to giving treatment, the courts will accept that, due to the urgent necessity of treatment, consent was implied.

Express consent: In this situation, people have expressed their consent to treatment in writing. This consent is clear, transparent and unambiguous. However, the consent given is explicit and limited to a particular treatment or intervention, and, if the three key elements of consent are not met, the consent is invalid. Express consent must be voluntary and informed, and the people must have the capacity to give their consent.8 Withdrawal of consent: Having once given consent, a person reserves the right to withdraw that consent at any stage of an intervention or procedure.8 Decision-making capacity Adults are presumed to have mental capacity, unless proven otherwise, and legal capacity is the legal recognition of people’s choices and their capacities to exercise their rights. In situations when an adult person’s mental capacity is compromised, the courts will make decisions on his or her behalf if no one else has been given power of attorney. In recent years, many jurisdictions have moved to support and assist those with impaired mental decision-making capacities. This person-centred approach focuses on the will, preferences, wishes and perspectives of a person. This type of decision-making is supported in various modes, including: assisted decision-making, co-decision-making and the application of courtappointed decision-makers.9 Issues such as whether a situation is temporary or permanent, as well as pos-

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Case Scenario Is consent voluntary and informed, and is the person giving consent recognised as a person under the law?

An 86-year-old person living alone at home has a lower leg wound for three months, requiring weekly dressings. The wound dressing procedure is painful, lengthy and tiring. The patient has refused to consent to the wound being dressed for two consecutive weeks. The community nurse has discussed the situation with the patient and has explained there is a risk of further infection. The nurse’s assessment is that the patient understands the information, appreciates its significance and can retain it. The nurse also knows that she cannot apply undue influence or duress to the patient but is very concerned about the patient’s health and safety.

Using the FREDA principles linked to the 2006 UN CRPD2, the clinician should consider the following possible steps.

Fairness and Respect: Review the mode of communication. Could the information be provided to the patient in multiple modes to ensure full understanding? (This is linked to UN CRPD Article 21: ‘Freedom of Expression and Opinion, and Access to Information’). n

n Equality: Review the time and place of giving the information. If the person is normally visited in the afternoon, could this be changed to a morning visit? (This is linked to Article 23: ‘Respect for Home and the Family’). n Dignity: Review the personnel at the meeting with the patient. Consider involving other persons, whom the patient might consider helpful. (This is linked to UN CRPD Article 17: ‘Protecting the Integrity of the Person’ and Article 22: ‘Respect for Privacy).

Autonomy: Review analgesia options, timing of procedure, wound dressing options and the personnel performing the procedure.11 (This is linked to UN CRPD Article 14: ‘Liberty and Security of the Person’ and Article 19: ‘Living Independently and being Included in the Community’). n

sible treatment options, are considered. All adults, and, in particular, older people and those who know that their mental capacity is failing, are encouraged to formally make their will and preferences known so they will be observed and legally recognised should the need arise. In a paradigm shift, Bronan and Flynn (2017)10 believe that the determinants of consent should be reviewed to reduce discrimination against certain parties.

Consent, however, still must be evaluated to ensure the person’s views are clearly expressed and communicated and the proposed course of action clearly agreed. The concept of consent continues to evolve.

As such, the FREDA principles and current legislation provide guiding frameworks to enable healthcare providers to consider their critical thinking, clinical reasoning and clinical judgement. Two case scenarios use the FREDA principles to provide human-rightsbased, decision-making aid.

This short article highlights the significance of protecting a person’s self-determination and autonomy when gaining valid, informed consent. Obtaining informed consent for clinical procedures, such as wound dressing, is both an ethical and a legal requirement. When correctly conducted, the consent process enables patients to make informed and voluntary decisions about accepting or declining clinical care.

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REFERENCES 1. Council of Europe, European Convention for the Protection of Human Rights and Fundamental Freedoms as amended by Protocols Nos. 11 and 14, 4 November 1950, ETS 5.available at : https://www. refworld.org/doicid/3ae6b3b04.html (accessed 12 March 2020)

5. UN Committee on Economic, Social and Cultural Rights (CESCR) [Cited 14 Feb. 2020]. General comment no. 14: the right to the highest attainable standard of health (Art. 12 of the Covenant). 11 Aug. 2000. E/C.12/2000/4. Available from: https://www. refworld.org/docid/4538838d0.html

2. Curtice M, Exworthy T. FREDA: a human rights-based approach to healthcare. The Psychiatrist.

2010;34:150-6.

6. Ploug T, Holm S. Informed consent and routinisation J Med Ethics 2013;39:214-8.

3. UN General Assembly [Cited 14 Feb. 2020]. Convention on the Rights of Persons with Disabilities. 13 Dec. 2006. A/RES/61/106, Annex I. Available from: https://www.refworld.org/docid/4680cd212.html 4. UN General Assembly [Cited 14 Feb. 2020]. Universal declaration of human rights. 10 Dec. 1948. 217 A (III). Available from: https://www.refworld.org/docid/ 3ae6b3712c.html [accessed 14 February 2020].

7. European Union [Cited 14 Feb. 2020]. Charter of fundamental rights of the European Union. 2012 Oct. 26. 2012/C 326/02. Available from: https:// www.refworld.org/docid/3ae6b3b70.html 8. Mills S, Mulligan A. Medical law in Ireland 3rd ed.

London: Bloomsbury; 2017.

9. S.I. No. 517/2016 - Assisted decision-making (capacity) Act 2015 (commencement of certain provisions) (no.

2) order 2016 [Cited 14 Feb. 2020]. Available from: http://www.irishstatutebook.ie/eli/2016/si/517/made/ en/print 10. Brosnan L, Flynn E. Freedom to negotiate: a proposal extricating ‘capacity’ from ‘consent’. Int J Law Context 2017;13(1):58-76.

11. Royal College of Nursing. Principles of consent: guidance for nursing staff, London: RCN;2017.

Health information and quality authority guidance on a human rights-based approach in health and social care services. Dublin: HIQA; 2019.

Cases

Useful Resources

I. UN CESCR 2000 37(3) (iv).

In Ireland, the National Consent Policy (Health Service Executive 2013) provides guidance about giving information to patients before consent to procedures.

The General Medical Council (2008) and the Royal College of Nursing10 also provide detailed information on informed consent.

(c) Full and effective participation and inclusion in society.

UN CRPD Article 3 – ‘The principles of the present Convention shall be:

(f ) Accessibility.

(a) Respect for inherent dignity and individual autonomy, including the freedom to make one’s own choices and the independence of persons.

(h) Respect for the evolving capacities of children with disabilities and respect for the rights of children with disabilities to preserve their identities.’

II. Rogers v Whitaker [1992] HCA 58.; Montgomery v Lanarkshire Health Board [2015] UKSC11.

III. Montgomery v Lanarkshire Health Board [2015] UKSC.

(d) Respect for differences and acceptance of persons with disabilities as part of human diversity and humanity. (e) Equality of opportunity. (g) Equality between men and women.

(b) Non-discrimination.

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DOI: 10.35279/jewma202011.06

Letizia Pieruzzi MD1, Elisabetta Iacopi MD1, Maria Grazia Buccarello RN2, Ludovica Tamburini RN2, Chiara Goretti MD1, Graziano Di Cianni MD3, Alberto Piaggesi MD1

Seek, and ye shall find:

Efficacy of proactive screening for diabetic foot ulceration in the community autonomously performed by nurses Diabetic foot ulceration (DFU) is a severe complication of diabetes mellitus associated with a high morbidity and mortality rate, whose treatment requires considerable financial costs.

This paper describes a test of the efficacy of proactive screening – autonomously managed by nurses in a community setting – in detecting patients at high risk of DFU, as an integrated part of a chronic care model strategy.

Keyword s:

diabetic doot dlcer; screening; community nurses; prevention; amputation

ABSTRACT Objective Our aim was to test the efficacy of proactive screening – autonomously managed by nurses in a community setting – in detecting patients at high risk of Diabetic Foot Ulcer (DFU), as an integrated part of a chronic care model strategy.

Research design and methods In a community setting in northwest Tuscany, where 421,382 people live in a mixed urban/rural area around the hospital of the University of Pisa, we trained 324 nurses according to the International Working Group on the Diabetic Foot guidelines for the screening of ulcerative risk. Nurses committed to screening the population of known diabetic patients, who were referred by their general practitioners, for DFUs annually.

Patients at high risk or with active DFUs were

promptly referred to our specialised diabetic foot clinic; all patients received education on prevention.

The results of the screening were retrospectively collected and analysed for the years 2014-2016.

Results During the study period we observed an increased number of screenings performed (+18.8% and +36.1% during the first and second year of followup, respectively; p < .05) and therefore an increased number of high-risk patients detected (+0.5% during the first year and +1.3% during the second year of follow-up; p < .05). Also, the number of patients with undiagnosed active foot ulceration significantly increased (+0.1% and +0.4% in the first and second year of the study, respectively; p < .05).

Conclusions In this study we demonstrate that increasing the rate of subjects actively screened increases, in parallel, the

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1 Diabetic Foot Section, University of Pisa 2 Chronic Care Model Nursing Service Northwest Tuscany Local Health Authority 3 Diabetic Services Northwest Tuscany Local Health Authority.

Correspondence: alberto.piaggesi@med.unipi. · Conflicts of Interest: None

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likelihood of finding patients at high risk of and with active DFUs. The improvement of this screening programme could favour an early detection of DFU cases to promptly intervene in and possibly interrupt the progression of the disease.

Key messages The prevalence of patients at-risk for foot ulceration is still underestimated among patients with diabetes A proactive screening is effective in sorting out patients at risk and patients with active lesions Nurses, once adequately trained, can effectively autonomously perform this activity INTRODUCTION Diabetic foot ulceration (DFU) is a severe complication of diabetes mellitus associated with a high morbidity and mortality rate, whose treatment requires considerable financial costs.1,2 The prevalence rates of DFU are 19-34%, with an annual incidence of 2%3 and a recurrence rate up to 65% within 3 years after healing. More than 85% of non-traumatic limb amputations originate from DFUs.4,5 Major amputations are more frequent in people with diabetes – about 10-30 times more than the general population – and mortality increases up to 80% at 5 years after amputation.6,7 Due to a global rise in both diabetes and life expectancy, a parallel global increase in DFU cases is expected in the future. Therefore, DFU has been compared to some forms of cancer for its general features: frequency, severity, chronicity and social cost.3 One of the criteria aspects of the management of DFU is related to the late referral of high-risk patients or patients with a DFU in the early phases of its evolution, which has been indicated as one of the most important determinants in the progression of its pathology towards the late and non-critical phases.8 For this reason, we need to implement a multidisciplinary, integrated approach for adequate treatment and prevention.

From a clinical point of view prevention and prophylactic foot care have been emphasised to reduce patient morbidity and the risk of amputations.9,10 The implementation of preventative programmes, including patient education, intensive podiatric care and the identification of risk factors7,11,12 have been shown to be cost-effective and cost saving.13

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International guidelines14 recommend a multilevel healthcare network15 in which diabetic patients might be referred without delay from a primary to secondary or tertiary level, according to the grade of complexity of the pathology; whereas the primary level is represented by the general practitioners (GPs), the secondary one by non-specialised diabetologic services, while the tertiary level is identified by the specialised diabetic foot clinic.

According to these recommendations, the Tuscany Local Health Authority has adopted this organisation for DFU management since 2003, with further implementation in 2016.16,17 To date, despite these recommendations, as confirmed by recent data reported in the regional healthcare agency database of Tuscany18, only 27% of type 2 diabetic patients are managed by specialised outpatient clinics; consequently, in the majority of cases, GPs play a crucial role in disease management, at least in the early phases.

Since 2009 a specific project for chronic diseases, including diabetes mellitus, BPCO, hypertension and stroke, has been implemented and financed by the Tuscany Health Authority following the Chronic Care Model (CCM).19 A network of GPs and nurses (1 nurse per 10,000 inhabitants) has been structured and committed to actively screening and managing these pathologies and their complications, including DFU. MATERIALS AND METHODS In 2013, in the northwest of Tuscany, we trained 324 nurses on the CCM according to the International Working Group on Diabetic Foot (IWGDF) guidelines for the screening of ulcerative risk in DFs. The nurses received a 4-hr module of specific training on physiopathology, natural history, clinical presentation and diagnostic approach to DFs, integrated with a 4-hr practical training delivered by the diabetic clinics active in the area. The structure of the course and training was delivered and supervised by the diabetologists and podologists of the DF section of the University Hospital of Pisa, which is the third-level centre for DFs in northwest Tuscany.

At the end of the course, the participants underwent an assessment of adequacy according to pre-defined criteria, taking into consideration both knowledge and skills.

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TUSCANY-NORTH-WEST-AREA SCREENING FOR LOWER-LIMB COMPLICATIONS IN DIABETIC PATIENTS

DATE____/____/_____

NAME______________________________________________________ DATE OF BIRTH____/____/_____ CITY OF RESIDENCE_________________________________________ GP__________________________ INSPECTION

RIGHT FOOT

LEFT FOOT

Previous ulcer or amputations

Yes____

No____

Yes____

No____

Active ulcers/Necrosis

Yes____

No____

Yes____

No____

Deformity

Yes____

No____

Yes____

No____

/Fissures

Yes____

No____

Yes____

No____

Odema/Erythemo

Yes____

No____

Yes____

No____

Cyanosis

Yes____

No____

Yes____

No____

Font cold

Yes____

No____

Yes____

No____

Thermal tresho

Yes____

No____

Yes____

No____

Absence of posterior tibial pulse

Yes____

No____

Yes____

No____

Absence of dorsalis pedidis pulse

Yes____

No____

Yes____

No____

Yes____

No____

Yes____

No____

Hypercheratosis/Onicopathies

PALPATION

MONOFILAMENT Lack of perception OUTCOME

Negative________

Next control_________________

Positive________

Refer to____________________

OPERATOR_________________________________________________

TUSCANY-NORTH-WEST-AREA SCREENING FOR LOWER-LIMB COMPLICATIONS IN DIABETIC PATIENTS

DATE____/____/_____

NAME______________________________________________________ DATE OF BIRTH____/____/_____ CITY OF RESIDENCE_________________________________________ GP__________________________ DOPPLER CW

RIGHT FOOT

LEFT FOOT

Absence of posterior tibial

Yes____

No____

Yes____

No____

Absence dorsalis pedis

Yes____

No____

Yes____

No____

Claudicatio intermittens

Yes____

No____

Yes____

No____

Rest pain

Yes____

No____

Yes____

No____

OUTCOME

Negative________

Next control_________________

Positive________

Refer to____________________

OPERATOR_________________________________________________

Figure 1. Screening questionnaire completed by nurses JOURNAL OF THE E UROPEAN WOU N D M A N AG EM EN T A SSO C IAT IO N â&#x20AC;&#x201A; 2 0 2 0 VO L 2 1 N O 1

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importance of daily foot inspection and hydration, of wearing adequate shoes and socks and other general recommendations on self-protecting behaviours.

The aim of this study was to evaluate the outcomes of the screening programme for the years 2014, 2015 and 2016.

After their training, the nurses started annually screenings of a population of known diabetic patients, who were referred to them by the patients’ GPs. Patients were examined in a dedicated ambulatory setting on a daily schedule, and each examination was performed by trained nurses, without direct involvement or supervision by doctors or podologists, and took 30 minutes.

For the purpose of this study, the general database of GPs for northwest Tuscany was retrospectively consulted to sort out the number of diabetic patients and to calculate the prevalence of the disease in the general population. The screening questionnaires, performed by nurses, were collected and examined to calculate the number of patients screened, the number and prevalence of high-risk patients and the number and prevalence of active DFUs intercepted.

Consequently, this screening protocol has become an integrated part of a CCM strategy, in a community living in an urban/rural area near Pisa of about 421,382 people.

For each patient screened, nurses were able to determine the class of risk for DFU by using a simple questionnaire shown in Figure 1. In that questionnaire nurses reported anamnestic risk factor data, detectable alterations with the inspection and palpation of the patient’s feet, vascular examination with ankle brachial index calculation and the presence of suspected neuropathy with the Semmes-Weinstein monofilaments evaluation. The questionnaire was based on the American Diabetes Association’s screening tool for at-risk diabetic feet20, and it was validated on a significant sample of admitted patients before the beginning of the study.

These data were validated by direct telephone contact with the patients, after the screening, double-checking if they were actually screened and if the conditions at the moment of the screening were actually those reported in the questionnaires.

The number of patients screened, their prevalence among diabetes population and the number of highrisk patients and active DFUs were calculated for the three areas where the programme was implemented.

Continuous data are presented as means (SDs) or medians (ranges), as appropriate for each variable.

All patients screened by nurses, irrespective of the level of risk, received information on prevention – the

Figure 2. Increase of the number of patients screened during study period p < .05 p < .05 8000 6817 6000

p < .05 4325

3856

4000

3160

2618

2442 2000

0

2014

2015 Not screened

36

2016 Screened

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Figure 3. Increase of the number of high-risk patients detected during study period 280

p < .05

240 p < .05

200 160

144 p < .05

120 80 40

52 21

0 2014

2015

2016

High risk A Chi-square test was applied for the comparison of the study groups.

(2.2%) patients for 2014, 2015 and 2016, respectively.

The statistical analyses were performed using a commercial software, StatView vers. 12.0 (SAS Institute, Gary Ill), on an iMac computer.

In the first year of the study we observed 2,442/6,767 (36.1%) patients screened (1,587 females and 855 males), with a mean age of 64.3 ± 13.4 years affected by type 2 diabetes. In the following years we observed 3,856/7,016 (54.9%) patients screened in 2015 (2,313/1,543 females/males), with a mean age of 66.5 ± 12.9 years and 6,817/9,435 (72.2%) patients screened in 2016 (4,090/2,727 females/males), with a mean age of 65.7 ± 14.3 years. No significant demographic differences were found between the groups.

RESULTS Data from northwest Tuscany’s register of GPs revealed that the number of patients affected by diabetes increased over the three years of follow-up in the study population, with a total of 6,767/421,382 (1.6%), 7,016/421,382 (1.7%) and 9,435/421,382

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Figure 4. Increase of the number of active DFU patients detected during study period 50

p < .05

45

p < .05

40 35 30

n=31(0.5%)

25

p < .05

20 15 10 5 0

n=8(0.3%) n=5(0.2%) 2014

2015

2016

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During the three years of the study we observed a statistically significant increase of the patients-screened percentage: 2442/6767 (36.1%), 3856/7016 (54.9%) and 6817/9435 (72.2%), p < .05 (Figure 2).

As reported in Figure 3, we also observed a statistically significant increase in the number of patients classified as high risk for DFU, according to the IWGDF guidelines: 21/2442 (0.8%) patients in 2014, 52/3856 (1.3%) in 2015 and 144/6817 (2.1%) in 2016 (p < .05). High-risk patients were referred to the specialised clinic for adequate secondlevel examination and education on DFU prevention.

Moreover, in parallel to the increase in the number of high-risk DFU patients detected we observed a significant increase in the identification of the number of active DFU patients during the study followup (Figure 4). This group of patients in the acute DFU phase, previously undiagnosed, was promptly referred to our hospital and consequently managed in a timely manner.

DISCUSSION Our data confirm the efficacy of a proactive screening programme to detect DFU patients at an early stage in order to adequately and in a timely manner refer them to specialist care. Our findings strongly support the beneficial effect of proactive screening for the interception of DFs in a heterogeneous, at-risk population. The increase in rates of both high-risk patients and active DFUs detected, in the period in which the screening was performed, is an indirect confirmation of the presence of the pathology in the population.

The importance of DFU screening was underlined in the previous guidelines on DFs and confirmed by the most recent ones published in May 2019.13 Screening is aimed at identifying patients with the risk of developing ulcers in order to apply adequate prevention. Screening also has a crucial importance in the identification of patients with pre-ulcerative or ulcerative lesions in the active phase that could not otherwise being recognised in order to promptly treat the disease and thus prevent its progression.

Therefore, by implementing suitable prevention, the aim of screening is to reduce the rate of hospitalisation for DFU and the long-term rate of lower-limb amputations.

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However, clear-cut data that confirm the impact of screenings on DFU outcomes are not yet available.21-32 According to recent guidelines, a multidisciplinary approach to the prevention and treatment of DFU, involving GPs, podiatrists and diabetologists, is the best choice for the patient. In fact, the prompt application of adequate multidisciplinary treatment has been shown to result in a 50% reduction of major lower-limb amputation, especially in high-risk patients.33 Therefore, an integrated intervention including healthcare professionals’ education and healthcare systems’ programmes that can identify the level of risk for DFU development early and limit the progression of disease, with the aim of reducing ulceration and the lower-extremity amputation rate, has the greatest influence on DF outcomes.

The direct involvement of nurses, specifically trained on DF, in a low-cost screening project make it possible to reach a large number of patients otherwise not intercepted, also giving them the occasion to get adequate information on DF and how to prevent it.

Many previous randomised, controlled diabetes studies evaluating the efficacy of foot care education for healthcare professionals report an improvement in foot care processes, an increase in the foot examination rate23,34-38 and an increase in the number of patients appropriately referred to a podiatrist.23,36 A concomitant increase in patient education23,36 and increased requests for protective footwear23,39 was also observed. An improvement in healthcare professionals’ diabetic foot knowledge is also reported in DF studies that have used medical education and a pre-test/post-test study design.22,39 An increased foot examination rate is also observed in a more recent non-randomised, stepped-wedge design, evaluating a single education session of nurses in a haemodialysis unit.40 A previous study from the Netherlands reports a significant reduction of lower-extremity amputations as an effect of the increasing number of podiatrists and multidisciplinary teams.41 In this study, during a period of about 10 years of implementation of the management of diabetes-related lower-limb complications, the incidence rate of diabetes-related, lower-

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extremity amputation decreased in both men (36%) and women (38%), and the duration of hospitalisation decreased over time.

have no data about the possible favourable impact of the screening programme on the long-term reduction of the major-amputation rate.

Another, more recent study shows that the discontinuation of podiatry care from Medicare in the US42 resulted in an increase in the number of hospitalisations for diabetic foot disease, consequently with an increase in health cost.

Moreover, since major-amputation rates are related to the whole Tuscany region, it was not possible to connect our findings to this outcome.

Both studies offer indirect evidence regarding the potential importance of healthcare organisation in DF care, including ulcer prevention.

Other authors demonstrate that by educating healthcare workers in a primary healthcare clinic it is possible to obtain an increase in the number of diabetic patients screened and, consequently, a significant quality improvement in the management of the disease.30 Similar results were obtained from a nurse-driven educative intervention on diabetic patientsâ&#x20AC;&#x2122; foot screening performed in four UK National Health Service dialysis units.40 We are aware of the limitations of this study, which is single centre, retrospective and without a control group.

However, this is the first interventional screening study with the aim of improving a large-scale screening programme for DFU reported in the literature.

However, we have to underline that a screening programme alone is not sufficient for adequate management of DFU. In fact, to obtain better long-term outcomes, we need, as strongly suggested by recent guidelines, a multilevel organisation composed of primary, secondary and tertiary care.

Although possibly biased, this study shows how increasing the rate of subjects actively screened in the population of known diabetic patients also increases the rates of high-risk patients and active DFUs detected; thus it is possible to detect them early and to promptly intervene, interrupting the progression of the disease.

CONCLUSIONS Our study demonstrates how an organised screening programme of diabetic patients, performed by nurses in the community, is effective in intercepting highrisk and ulcerated patients in an early phase of the clinical course of the disease, then addressing them to specialist care and giving preventive education on DF, eventually reducing the progression of the disease towards the later, more critical stages.

Because of the short-term follow-up of the study we

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REFERENCES 1. Jupiter DC, et al. The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review. Int Wound J 2016; 13(5):892-903.

16. Regione Toscana Delibera Consiglio Regionale 698 del 19 Luglio 2016. Percorso diagnostico terapeutico assistenziale per la persona affetta da piede diabetico.

Linee di indirizzo regionali 2016.

30. Allen ML, Van der Does AM, Gunst C. Improving diabetic foot screening at a primary care clinic: A quality improvement project. Afr J Prim Healthcare Fam Med 2016; 8(1):e1-9.

2. Kerr M, Rayman G, Jeffcoate WJ. Cost of diabetic foot disease to the National Health Service in England. Diabet Med 2014; 31(12):1498-504.

17. Regione Toscana Delibera Consiglio Regionale 603 del 24 Dicembre 2003. Linee-guida organizzative per la gestione del piede diabetico 2003

3. Armstrong DG, Boulton AJM, Bus SA. Diabetic foot ulcers and their recurrence. N Engl J Med 2017; 376(24):2367-75.

18. Available at https://www.ars.toscana.it/.

31. Schoen DE, et al. Improving rural and remote practitioners’ knowledge of the diabetic foot: Findings from an educational intervention. J Foot Ankle Res 2016; 9:26.

4. Wu SC, et al. Foot ulcers in the diabetic patient, prevention and treatment. Vasc Health Risk Manag 2007; 3(1):65-76.

20. Boulton AJ, et al. Comprehensive foot examination and risk assessment. Endocr Pract 2008; 14(5):57683.

5. Dang CN, Boulton AJ. Changing perspectives in diabetic foot ulcer management. Int J Low Extrem Wounds 2003; 2(1):4-12.

21. Herring R, et al. Can an interprofessional education tool improve healthcare professional confidence, knowledge and quality of inpatient diabetes care? A pilot study. Diabet Med 2013; 30(7):864-70.

6. Bharara M, et al. Diabetes and landmine-related amputations: A call to arms to save limbs. Int Wound J 2009; 6(1):2-3.

7. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005; 293(2):217-28.

8. Manu C, et al. Delayed referral of patients with diabetic foot ulcers across Europe: Patterns between primary care and specialised units. J Wound Care 2018; 27(3):186-92.

9. Pinzur MS, et al. Guidelines for diabetic foot care: Recommendations endorsed by the Diabetes Committee of the American Orthopaedic Foot and Ankle Society. Foot Ankle Int 2005; 26(1):113-9.

10. Schaper NC, et al. Prevention and management of foot problems in diabetes: A summary guidance for daily practice 2015, based on the IWGDF guidance documents. Diabetes Res Clin Pract 2017; 124:84-92.

11. Woodbury MG. Diabetic foot risk assessment.

Diabetes Metab Res Rev 2016; 32(4):376-8.

12. Moreland ME, et al. Diabetes preventive care and non-traumatic lower extremity amputation rates. J Healthc Qual 2004; 26(5):12-7.

13. Ragnarson Tennvall G, Apelqvist J. Health-economic consequences of diabetic foot lesions. Clin Infect Dis 2004; 39 Suppl 2:S132-9.

14. Available at https://iwgdfguidelines.org/preventionguideline/.

15. Schaper NC, Van Netten JJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA. IWGDF Practical Guidelines on the prevention and management of diabetic foot disease. Diabetes Metab Res Rev; In press.

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19. Regione Toscana Delibera Consiglio Regionale 467 del 3 Giugno 2009.

22. Jones J, Gorman A. Evaluation of the impact of an educational initiative in diabetic foot management. Br J Community Nurs 2004; 9(3):S20-6.

23. Donohoe ME, et al. Improving foot care for people with diabetes mellitus: A randomized controlled trial of an integrated care approach. Diabet Med 2000; 17(8):581-7.

24. Holmboe ES, Prince L, Green M. Teaching and improving quality of care in a primary care internal medicine residency clinic. Acad Med 2005; 80(6):571-7.

25. Vidal-Pardo JI, et al. Effect of an educational intervention in primary care physicians on the compliance of indicators of good clinical practice in the treatment of type 2 diabetes mellitus [OBTEDIGA project]. Int J Clin Pract 2013; 67(8):750-8.

32. Bruckner M, et al. Project LEAP of New Jersey: Lower extremity amputation prevention in persons with type 2 diabetes. Am J Manag Care 1999; 5(5):609-16.

33. Van Damme H, Limet R. The diabetic foot [in French]. Rev Med Liege 2005; 60(5-6):516-25.

34. McDermott RA, et al. Improving diabetes care in the primary healthcare setting: A randomised cluster trial in remote Indigenous communities. Med J Aust 2001; 174(10):497-502.

35. Frijling BD, et al. Multifaceted support to improve clinical decision making in diabetes care: A randomized controlled trial in general practice. Diabet Med 2002; 19(10):836-42.

36. Litzelman DK, et al. Reduction of lower extremity clinical abnormalities in patients with non-insulindependent diabetes mellitus: A randomized, controlled trial. Ann Intern Med 1993; 119(1):36-41.

37. Glasgow RE, et al. A practical randomized trial to improve diabetes care. J Gen Intern Med 2004; 19(12):1167-74.

38. Meigs JB, et al. A controlled trial of web-based diabetes disease management: The MGH diabetes primary care improvement project. Diabetes Care 2003; 26(3):750-7.

26. O’Brien KE, et al. Effect of a physician-directed educational campaign on performance of proper diabetic foot exams in an outpatient setting. J Gen Intern Med 2003; 18(4):258-65.

39. Pataky Z, et al. A first evaluation of an educational programme for health care providers in a long-term care facility to prevent foot complications. Int J Low Extrem Wounds 2007; 6(2):69-75.

27. Kiefe CI, et al. Improving quality improvement using achievable benchmarks for physician feedback: A randomized controlled trial. JAMA 2001; 285(22):2871-9.

40. Brand SL, et al. Evaluation of the effect of nurse education on patient-reported foot checks and foot care behaviour of people with diabetes receiving haemodialysis. Diabet Med 2016; 33(2):204-7.

28. Harris SB, et al. Impact of a quality improvement programme on primary healthcare in Canada: A mixed-method evaluation. Health Policy 2015; 119(4):405-16.

41. Van Houtum WH, et al. Reduction in diabetesrelated lower-extremity amputations in the Netherlands: 1991-2000. Diabetes Care 2004; 27(5):1042-6.

29. Szpunar SM, et al. Improving foot examinations in patients with diabetes: A performance improvement continuing medical education (PI-CME) project.

Diabetes Educ 2014; 40(3):281-9.

42. Skrepnek GH, Mills JL, Armstrong DG. Foot-inwallet disease: Tripped up by “cost-saving” reductions?

Diabetes Care 2014; 37(9):e196-7.

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DOI: 10.35279/jewma202011.07

Jan Stryja MD1,3, Daniel Riha MD2,3, Jerzy Szkatula MD2,3

A silver-based antimicrobial dressing for the prevention of surgical site infection - a pilot study Surgical site infection is a postoperative complication that affects many surgical patients worldwide. It has been estimated that up to 60% of SSIs are preventable and that their risk can be minimised by applying the best practice in the perioperative period.

Proper wound management is one way of preventing the incidence of SSIs. This paper describes results of a descriptive case series focused on the usage of silver dressing on post-operative wounds.

Keyword s:

surgical site infection, antimicrobial dressing, prevention of infection ABSTRACT Background Surgical site infection (SSI) is a postoperative complication that affects many surgical patients worldwide.

It has been estimated that up to 60% of SSIs are preventable and that their risk can be minimised by applying the best practice in the perioperative period.

Proper wound management is one way of preventing the incidence of SSIs. Aim Our aim was to test the SSI-related serviceability of a novel silver-based dressing material for acute wound management on a group of 22 patients who underwent planned surgery.

dures. We monitored the total number of dressing changes until stitches were removed and the incision had healed, possible local and systemic clinical signs of infection, the current state of the wound and the patient’s and surgeon’s satisfaction with the dressing.

Results No superficial or deep surgical site infection was observed during the treatment or follow-up periods (total: four weeks). All incisions (100%, 22) healed by primary intention with no wound dehiscence. The dressing was well tolerated by the patients (71.4% rated it “excellent”, 23.8% rated it “very good”) and the healthcare professionals’ satisfaction rates were also positive (66.7% rated it “excellent”, 33.3% rated it “very good”).

Method Our observational case series is a descriptive clinical study for quality assurance purposes. Participants were male and female patients over 18 years old who were scheduled to undergo “clean” surgical proce-

Conclusion The dressing has shown good clinical serviceability and was well tolerated by the patients. To obtain robust evidence for wider use, a randomised controlled trial is required.

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1. Salvatella LTD, Trinec, Czech Republic 2. Podlesi Hospital, Trinec, Czech Republic 3. Vascular surgeon senior consultant

Correspondence: jan.stryja@atlas.cz · Conflicts of interest: None.

The company manufacturing the product tested in the study provided free samples of the dressing but had no influence on the clinical evaluation.

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Key messages • Paper describes results of a descriptive case series focused on the usage of silver dressing on post- operative wounds.

• The aim of the study was to test the SSI-related serviceability of a novel silver-based dressing for acute wound management.

• No superficial or deep surgical site infection was observed during the treatment or follow-up periods.

INTRODUCTION Surgical site infection (SSI) is a postoperative complication that affects many surgical patients worldwide.

It is the third most commonly reported health-associated infection1 and results in significant patient postoperative morbidity and mortality and increased additional health-care related costs. Surgical site infections are defined2 as infections occurring up to 30 days after surgery (or up to one year after surgery in patients receiving implants) and affecting either the skin incision or deep tissue at the operation site. The risk of SSI is influenced by a number of intrinsic and extrinsic factors, particularly the number of microorganisms present at or introduced into the incision during the surgical procedure. The incidence of SSIs varies depending on multiple factors, including the type of operation, the patient’s pre-existing health status, and the quality of perioperative management. In 2017, Berríos-Torres et al.3 reported that almost 50% of SSIs become evident after discharge. This may be caused by efforts to shorten patient’s stay (often seen in many hospitals), which leads to early discharge and can make diagnosis and surveillance of SSIs more difficult. It is questionable whether health-care systems across Europe are able to ensure appropriate conditions for good surveillance and smooth diagnosis of SSIs in outpatient settings. It has been estimated that up to 60% of SSIs are preventable4 and that the risk of such infections can be minimised by applying best practice in the perioperative period. Precautions to prevent SSIs are particularly focused on the reduction of risk factors present at the time of surgery to reduce or forestall contamination of the operating site. The rates of SSIs associated with surgery5 on sterile sites are, therefore, very low (< 2%) compared with the rates of SSIs associated with surgery on contaminated sites, which may be over 10%. An excellent surgical technique, preoperative preventive precautions and proper wound management are considered the foun-

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dations of an undisturbed healing process2 and are among the ways to decrease the number of clinically manifesting SSIs. Current clinical recommendations for SSI prevention can be found in several published guidelines: the 2018 World Health Organization (WHO) Global Guidelines for the Prevention of Surgical Site Infection); the National Institute for Health and Care Excellence (NICE) Surgical Site Infections: Prevention and Treatment, updated in 20177; and the Centers for Disease Control and Prevention’s (CDC) Guideline for the Prevention of Surgical Site Infection3, published in 2017. These guides highlight specific recommendations for the preoperative phase (staphylococcus aureus screening and decolonisation, smoking cessation, modification of treatment in the light of existing medical conditions, thoughtful hair removal, patient showering and reasonable surgical antibiotic prophylaxis), the intraoperative phase (preparing surgical hand and skin at the surgical site, wearing sterile gowns and sterile gloves, maintaining patient perioperative normothermia and optimal oxygenation and covering surgical incisions with an appropriate interactive dressing) and the postoperative phase (an aseptic technique for changing or removing surgical wound dressings, adequate nutritional interventions and proper wound care after discharge from hospital).

Antimicrobial dressings are an effective tool for local treatment of infected wounds. Although they are widely used in clinical practice, we have very little data or evidence to support their universal usage in wound management, especially in the prevention of wound infection.8 Silver dressings provide extensive protection against bacteria, fungi and viruses, including nosocomial pathogens, methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococci (VRE), making them a valuable adjunct in the prevention and treatment of infection. In 2017, Tisosky et al.9 conducted a clinical trial showing that the use of silver dressings significantly reduced the incidence of superficial and deep prosthetic joint infection following total joint replacement. A literature review10 published in 2014 reported that silver nylon dressings are associated with a reduced risk of SSI in small studies across several specialities, including colorectal surgery, neurosurgery, spinal surgery and some cardiac and orthopaedic procedures, although the authors recommend larger powered trials on these cohorts to determine the comparative effectiveness

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of silver nylon dressings in the prevention of SSIs. The 2017 update to the NICE guidelines7 concludes that no particular dressing type emerges as the most effective in reducing the risk of SSI, although silver nylon dressings may be more effective than gauze.

Positive outcomes of clinical trials investigating the effectiveness of silver dressings for SSI incidence reduction provide some justification for stating that antimicrobial dressings could decrease the negative impact of extrinsic SSI risk factors related to contamination of the patient’s body surface. Nevertheless, the current evidence for the efficacy of antimicrobial dressings in reducing the risk of SSI is weak.

The aim of our observational pilot case series is to describe SSI-related effectiveness of a novel silverbased dressing material for acute wound management through a study of a group of 22 patients who underwent planned surgery.

METHODS The observational pilot case series has been designed as a descriptive clinical study to evaluate the efficacy of a silver dressing for quality assurance purposes. The study was approved by a local ethics committee Český Těšín. The multicentric study was carried out on patients who visited the Salvatella Ltd surgical outpatient clinic in Trinec, Czech Republic or the surgical department of Hospital Podlesi, Trinec, Czech Republic, for planned surgery from September 2019 to November 2019. Salvatella Ltd is an outpatient health-care facility specialising in general surgery, vascular surgery and complex treatment of non-healing wounds. It is located in the North Moravian region.

Hospital Podlesi is part of the Czech Cardiovascular Centre Network. Its surgical department provides specialised care to patients with surgical and vascular disorders, and its catchment area has more than 500,000 inhabitants.

Patients included in the sample were randomly selected. Male or female patients over 18 years old who were consecutively scheduled to undergo “clean” surgical procedures in an outpatient or inpatient setting at either of the aforementioned health-care facilities and who had provided written informed consent to participate in the study were included. Patients were treated by three experienced surgeons in the two institutions. The exclusion criteria were surgical procedures to treat infections, primary infected wounds, a known allergy to the tested dressing, an inability

to follow the study protocol or recommendations specific to the primary diagnosis.

Patient characteristics, including age at the time of surgery, sex, smoking habits, body mass index, grave comorbidities and medication, were collected. All surgical incisions were treated by primary closure using skin sutures. The intervention consisted of the application of the sterile silver-based dressing onto the sutured incision at the time of surgery and during subsequent dressing changes. The dressing was placed on the incision before the patient left the operation hall and removed according to the clinical needs of the wound (leakage, spontaneous dressing release or requirement for a surgeon to examine the wound).

At the end of the treatment period, the stitches were removed from the incision (upon the decision of the attending surgeon) and the wound was covered with the last sheet of dressing. Clinical data were collected by the attending surgeon and continuously recorded in the clinical report. The same investigator observed the patient at the hospital (in cases of inpatient intervention), at the outpatient clinic and during the follow-up period. We monitored the frequency and the total number of dressing changes until the stitches were removal and the incision had healed, the possible local and systemic clinical signs of infection and the current state of the wound. The postoperative protocol was consistent across all surgeons and at both institutions and was compliant with an institutional standardised protocol for all patients. No patient received perioperative antibiotics. The study patients were followed prospectively to check for the onset of superficial or deep infection. The treatment period was terminated two weeks after surgery by removal of the suture material, after which the follow-up period lasted a further two weeks. The final diagnosis for SSI was made by the attending surgeon at the end of the follow-up period (i.e. four weeks after surgery) based on the criteria defined by the WHO guidelines11 for safe surgery and the NICE guide7, published in 2017. Assessed clinical signs of infection included purulent drainage, wound pain or tenderness, localised swelling, redness, heat, cellulitis of soft tissue at the place of surgery or wound abscess.

Tolerance of the dressing (assessed by the patient) and satisfaction with the local treatment and the dressing was evaluated by a healthcare professional (HCP) or patients themselves by labelling the appropriate answer from the offered options (see Table 5) during the final clinical appointment at the end of the second week of the observation.

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Table 1. Population characteristics of the study group Population Characteristics Age at surgery, yrs, mean ± SD; median

50.7±12.7 ; 46

Sex Female, % (n)

61.9 (13)

Male, % (n)

38.1 (8)

Tobacco use

23.8 (5)

Body mass index over 35, % (n)

14.3 (3)

Drug allergy %,(n)

9.5 (2)

Diabetes mellitus, % (n)

9.5 (2)

Length of incision, cm, mean ± SD; median

5.3±2.1 ; 6

DESCRIPTION OF THE TESTED DRESSING The tested dressing was developed in 2018 by a Czech technological company, Grade Medical.* The dressing is produced using a patented nanotechnology called sol-gel, which works through a spray atomisation method. The inner surface of the dressing comprises an organic-anorganic hybrid oligomer with silver ions bound in a fluid containing silver nitrate12 (see Figures 1 and 2). In a moist environment, the silver ions are released from the dressing pad and interfere with present microorganisms. This provides an antibacterial barrier that protects the surface of a wound from external contamination, potentially reducing the risk of wound infection. The dressing is available for clinical usage in two forms, both of which were available for dressing changes during the trial. The first form has an adhesive border and is used for low-exuding acute wounds, while the second one has no border and is suitable for non-healing infected wounds.

RESULTS The study involved 22 surgeries (postoperative wounds) performed on 22 patients from September 1, 2019 to November 30, 2019. One patient was excluded from the observation due to a failure to follow the study protocol. Therefore, 21 patients were included for final evaluation. The demographic details of the study group are presented in Table 1.

All patients underwent surgical interventions resulting in clean or clean-contaminated wounds2 with a generally low risk of SSIs. Table 2 presents a detailed list of the surgical interventions and the length of the procedures.

We did not observe any superficial or deep SSIs

among the studied group of patients during either the treatment period or the follow-up period (lasting a total of four weeks). All incisions healed by primary intention with no wound dehiscence (see Table 3).

The length of treatment was similar for surgeries in both inpatient and outpatient setting (see Table 4). In cases of inpatient treatment, patients were discharged from the hospital on the second day (2.6 ± 0.8 days; median 2 days) after surgery. In both groups, the stitches were removed from the wound margins on the 10th day after wound closure (hospital surgeries 10.4 ± 1.8 days; median 10 days, outpatient surgeries 11.5 ± 2.6 days; median 10 days). The dressing was changed four times per treatment period (see Table 4). In 81% (n = 17) of wounds, no wound exudation was observed, and the surface remained dry. We observed two adverse events with no association to the tested dressing: one patient suffered embolisation to the lung after varicose vein surgery, although the complication was resolved without consequences.

Another patient noticed a seroma in the inguinal canal after inguinal hernia laparoscopic repair. Four patients (19%) noticed temporary itching under the adhesive border of the dressing, a symptom that completely subsided after treatment with the silver-based dressing was terminated. Tolerance of the dressing was evaluated as “excellent” by 74.1% of patients and “very good” by 23.8% of patients. Patient satisfaction with the dressing was rated as “excellent” by 61.9% of patients, as “very good” by 28.6% and as “good” by 9.5% of patients (see Table 3c). Satisfaction of HCPs with the dressing was “excellent” in 66.7% of cases and “very good” in 33.3% of cases (see Table 3c).

DISCUSSION Surgical site infections are unpleasant complications

*StopBac, Grade Medical

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Table 2a. Type of surgical intervention in the study group Type of surgical intervention Varicose vein surgery, % (n)

38.1 (8)

Superficial soft-tissue benign tumour excision, % (n)

28.6 (6)

Strumectomy, % (n)

4.8 (1)

Laparoscopic hernia repair, % (n)

9.5 (2)

Laparoscopic cholecystectomy, % (n)

9.5 (2)

Direct endarterectomy, % (n)

4.8 (1)

Thoracoscopic sympathectomy, % (n)

4.8 (1)

Length of surgical procedure , min., mean ± SD; median

39 ± 22; 40

Table 2b. Anatomical location of surgery in the study group Anatomical location of surgery Groin, % (n)

38.1 (8)

Back, % (n)

14.3 (3)

Abdomen, % (n)

19.0 (4)

Chest, % (n)

4.8 (1)

Neck, % (n)

9.5 (2)

Thumb, % (n)

9.5 (2)

Thigh, % (n)

4.8 (1)

that occur after surgical procedures, impairing the patient’s quality of life and causing dissatisfaction and frustration among surgeons and other clinicians.

They are connected with significant patient morbidity and mortality, longer hospital stays and considerable extra health-care costs.13 In common clinical practice, the preoperative elimination of all intrinsic and extrinsic risk factors for SSIs can be difficult. Although health-care facilities have to follow many preventive procedure-dependent and patient-related precautions to forestall the transmission of germs to the site of surgery in the perioperative period, SSIs remain a substantial threat. Efforts to prevent SSIs are based on early detection of high-risk patients, preoperative preparation of the patient, skilled medical staff and adequate equipment, a gentle and tactful operative technique, and postoperative wound management. In the early postoperative period, dressing the incision provides a barrier with an absorptive capacity to manage wound exudation and ensure a secure, stable and healing-

friendly environment. As Woo reported in 201214, silver-based antimicrobial dressings can reduce the bacterial burden on the surface of a chronic wound, protect wound surfaces from microbial invasion and effectively suppress bacterial proliferation, For acute wounds, however, the evidence remains questionable. Routine use of antimicrobial dressings for the postoperative management of surgical wounds can increase treatment costs, affect patient by possible local action of the antimicrobials and have an impact on the antimicrobial resistance of present germs. In 2019, Stanirowski et al.15 published the results of a randomised controlled on women (N = 543) who underwent caesarean section, which revealed that the use of bacterial-binding dressings following caesarean section could reduce the incidence of SSI and healthcare costs. In 2017, Tisosky et al.9 reported a positive impact of application of antimicrobial dressing on the postoperative wound on the reduction of SSI incidence. Their case-control study (N = 834) discovered that the use of a silver dressing significantly reduced the incidence of superficial and deep prosthetic joint

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Table 3a. Overall treatment outcomes Total number of surgical site infections, % (n)

0 (0)

Total number of primary healed wounds, % (n)

100 (21)

Adverse events with no connection to the dressing, % (n)

9.5 (2)

Adverse event with possible connection to the dressing - itching, % (n)

19 (4)

Table 3b. Dressing tolerance evaluated by patient Dressing tolerance evaluated by patient (1-5) median

1

Dressing tolerance evaluated by patient: “excellent”, % (n)

74.1 (15)

Dressing tolerance evaluated by patient: “very good”, % (n)

23.8 (5)

Dressing tolerance evaluated by patient: “good”, % (n)

4.8 (1)

Table 3c. Satisfaction with the dressing evaluated by patient/HCP Satisfaction with the dressing evaluated by patient (1-5) median

1

Satisfaction with the dressing evaluated by patient: “excellent”, % (n)

61.9 (13)

Satisfaction with the dressing evaluated by patient: “very good”, % (n)

28.6 (6)

Satisfaction with the dressing evaluated by patient: “good”, % (n)

9.5 (2)

Satisfaction with the dressing evaluated by HCP (1-5) median

1

Satisfaction with the dressing evaluated by HCP: “excellent”, % (n)

66.7 (14)

Satisfaction with the dressing evaluated by HCP: “very good”, % (n)

33.3 (7)

infection following total joint replacement.

Our pilot study describes our experience with a novel silver-based dressing material appointed for acute wound management. It is based on the theoretical assumption that the antimicrobial action of the tested dressing would be effective in decreasing the incidence of SSIs. The available European Centre for Disease Prevention and Control (ECDC) data16 shows that in 2015, the incidence of SSIs in colon surgery in the Czech Republic reached eight cases per 100 operations. Data on other surgical procedures performed in the Czech Republic are not currently available. If we apply the available data to our study group, the expected incidence rate would be 1.7 SSIs in total.

Comparing the Czech countrywide incidence and our study group incidence of SSIs, we cannot exclude a potential positive effect of the tested antimicrobial dressing. However, critical analysis of this finding and the known limitations of this study (a low number of participants, no control group, no randomisation,

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a broad spectrum of surgical procedures and surgeries performed in outpatient and inpatient setting) prevents us from definitively proving a direct effect of the tested dressing on the zero incidence of SSIs observed in our study group. Nevertheless, patients and HCP involved in this study expressed positive subjective clinical experience based on an evaluation of the dressing tolerance (“excellent”; range 1-5) and overall satisfaction with local treatment of wounds and the tested dressing (patients and HCP: “excellent”; range 1-5). The adverse events associated with the tested dressing were few and were all related to the adhesive border of the dressing (erythema, itching and burning).

IMPLICATIONS FOR CLINICAL PRACTICE The tested sterile antimicrobial dressing can be used in clinical practice for covering surgical wounds. We have confirmed its safety and good tolerance by patients in inpatient and outpatient settings. We see no

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Table 4. Treatment Period Description Total number of dressing changes, mean ± SD; median

4.2 ± 0.7; 4

Total length of treatment (i.e. suture removal), mean ± SD; median

10.7 ± 2.1; 10

Length of hospitalization - inpatient setting, mean ± SD; median

2.6 ± 0.8; 2

Total length of treatment for inpatient surgeries, mean ± SD; median

10.4 ± 1.8; 10

Total length of treatment for outpatient surgeries, mean ± SD; median

11.5 ± 2.6; 10

Length of treatment - outpatient setting, mean ± SD; median

8.8 ± 2.6; 9

No wound exudation, % (n)

81 (17)

Surrounding skin reaction, % (n)

4.8 (1)

Table 5.

Satisfaction scale for the trial (1-5) excellent

1

very good

2

good

3

poor

4

bad

5

reason to avoid usage of the dressing for the perioperative management of surgical wounds in high-risk patients and high-risk surgical procedures.

FURTHER RESEARCH There is a need for well-designed randomised prospective studies confirming the effects of different types of antimicrobial dressings on the reduction of SSI incidence. Such studies should be conducted on larger populations of high-risk patients.

CONCLUSION Regarding the aims of this study, we can confirm good serviceability of tested dressing in both outpatient and inpatient setting. We do not see any reason to avoid using antimicrobial silver-based dressings for the perioperative management of surgical wounds in high-risk patients undergoing high-risk surgical procedures. To obtain robust evidence for widespread use of the tested antimicrobial dressing on non-complicated incisions, it is necessary to design and carry out a larger randomised controlled trial. 

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REFERENCES 1. Suetens C, Latour K, Kärki T, Ricchizzi E, Kinross P, Moro ML et al. Prevalence of healthcare-associated infections, estimated incidence and composite antimicrobial resistance index in acute care hospitals and long-term care facilities: Results from two European point prevalence surveys, 2016 to 2017.

Euro Surveill 2018; 23(46):1800516. doi:10.2807/1560-7917.ES.2018.23.46.1800516 2. Stryja J, Sandy-Hodgetts K, Collier M, Moser C, Ousey K, Probst S et al. Surgical site infection: Preventing and managing surgical site infection across health care sectors. J Wound Care 2020; 29(2 Suppl 2b): S1–S69 3. Berríos-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg 2017; 152(8):784–791. doi:10.1001/jamasurg.2017.0904 4. Umscheid CA, Mitchell MD, Doshi JA, Agarwal R, Williams K, Brennan PJ. Estimating the proportion of healthcare-associated infections that are reasonably preventable and the related mortality and costs. Infect Control Hosp Epidemiol 2011; 32(2):101–114. Doi: 10.1086/657912 5. European Centre for Disease Prevention and Control.

Healthcare-associated infections: surgical site infections. In: ECDC. Annual epidemiological report for 2016. Stockholm: ECDC; 2018. European Centre for Disease Prevention and Control. Surgical site infections. In: ECDC. Annual epidemiological report for 2016. Stockholm; 2018 ECDC

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6. Allegranzi B. [Internet]. World Health Organisation.

WHO surgical site infection prevention. Geneva, Switzerland: WHO Document Production Services; ISBN 978 92 4 154988 2 [2016]. Available at [http:// www.who.int].

7. National Institute for Health and Clinical Excellence (NICE). Guidance. Surgical site infection: Prevention and treatment of surgical site infection [Internet].

London: RCOG Press [2017; 2018 Nov 16]. Available at [https://tinyurl.com/y9spc75p].

8. Dumville JC, Gray TA, Walter CJ, Sharp CA, Page T. Dressings for the prevention of surgical site infection.

Cochrane Database Syst Rev 2014; 9:CD003091. doi:10.1002/14651858.CD003091.pub3 9. Tisosky AJ, Iyoha-Bello O, Demosthenes N, Quimbayo G, Coreanu T, Abdeen A. Use of a silver nylon dressing following total hip and knee arthroplasty decreases the postoperative infection rate. J Am Acad Orthop Surg Glob Res Rev 2017 Oct 17;1(7):e034. doi:10.5435/JAAOSGlobalD-17-00034 10. Abboud EC, Settle JC, Legare TB, Marcet JE, Barillo DJ, Sanchez JE. Silver-based dressings for the reduction of surgical site infection: Review of current experience and recommendation for future studies.

Burns 2014; 40 Suppl 1:S30–S39. doi: 10.1016/j. burns.2014.09.011

12. published on-line http://www.stopbac.cz/ 13. Jenks PJ, Laurent M, McQuarry S, Watkins R. Clinical and economic burden of surgical site infection (SSI) and predicted financial consequences of elimination of SSI from an English hospital. J Hosp Infect 2014; 86(1):24–33. doi: org/10.1016/j. jhin.2013.09.012 14. Woo KY, Coutts PM, Sibbald RG. A Randomized Controlled Trial to Evaluate an Antimicrobial Dressing with Silver Alginate Powder for the Management of Chronic Wounds Exhibiting Signs of Critical Colonization. Adv Skin Wound Care 2012 Nov; 25(11): 503-8. doi: 10.1097/01.

ASW.0000422628.63148.4b 15. Stanirowski P, Davies H, McMaster J, Mealing S, Sawicki W, Cendrowski K, et al. Cost-effectiveness of a bacterial-binding dressing to prevent surgical site infection following caesarean section. J Wound Care 2017; 28: 222-228. doi: 10.12968/ jowc.2019.28.4.222.

16. Healthcare-associated infections: Surgical site infections [dataset]. 2020 Feb 26 [cited 2020 Feb 29] Available from: https://atlas.ecdc.europa.eu/public/ index.aspx?Dataset=27&HealthTopic=77. Dataset provided by ECDC based on data provided by WHO and Ministries of Health from the affected countries

11. World Health Organization. Patient Safety. WHO guidelines for safe surgery 2009: Safe surgery saves lives [Internet]. 2009 [cited 2019 May 7]. ISBN: 9789241598552. Available at [https://tinyurl.com/ rhsupup]

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Powerful results in stalled wounds PICO◊ sNPWT* has been shown to significantly reduce wound area by 39.1%† and depth by 32.5%‡ when compared with tNPWT** in patients with VLUs and DFUs over 12 weeks.1 Turn around wound healing trajectory more effectively than standard dressings and tNPWT with PICO.2 Helping you get CLOSER TO ZERO◊ delay in wound healing smith-nephew.com/pico

PICO◊ 14

Single Use Negative Pressure Wound Therapy System

References: 1. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Rep Regen. 2019. May 14 https://doi.org/10.1111/wrr.12727. 2. Dowsett C, et al. Use of PICO◊ to improve clinical and economic outcomes in hard-to-heal wounds. Wounds International. 2017;8, p53–58. * Single Use Negative Pressure Wound Therapy (sNPWT). † Mean reductions of 90.2 vs 51.0%; p<0.001; ITT population. ‡ Mean reductions of 45.6 vs 13.2%; p=0.014; ITT population. ** Traditional Negative Pressure Wound Therapy (tNPWT). ◊Trademark of Smith & Nephew. All Trademarks acknowledged. ©October 2019 Smith & Nephew. AWM-AWD-20619 | GMC0897b

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DOI: 10.35279/jewma202011.08

Kirsi Isoherranen, MD, PhD1, Milla Kallio, MD2, Julie Jordan O`Brien, RNP, MSc Nursing3, Heli Lagus, MD4

Clinical characteristics of lower extremity ulcers Common causes of lower-extremity ulcers are relatively easy to diagnose, but exact wound diagnosis needs always a holistic approach and a careful evaluation of the wound patient. Systematic assessment and the use of check-lists provides diagnostic tools. This review aims to provide clinicians with an overview of the different aetiologies of leg ulcer by describing the clinical characteristics of each aetiology. It also aims to provide tools for health-care providers when assessing a lower-extremity ulcer patient.

Keywords:

venous leg ulcers; arterial ulcers; mixed arterial and venous leg ulcers; pressure ulcers; diabetic foot ulcers; atypical wounds

ABSTRACT Background Exact diagnosis of lower-extremity ulcers is essential for successful ulcer management, and it often needs a multidisciplinary approach. The most common aetiologies for lower-extremity leg ulcers are venous, arterial, mixed venous and arterial, diabetic and pressure ulcers. However, atypical wounds comprise approximately 20% of chronic wounds and should be kept in mind during differential diagnosis.

Aim This review aims to provide clinicians with an overview of the different aetiologies of leg ulcer by describing the clinical characteristics of each aetiology.

It also aims to provide tools for health-care providers when assessing a lower-extremity ulcer patient.

Findings Ulcers with more than one aetiology are not uncommon. This awareness is increasing, and a holistic,

systematic and checklist-based assessment is strongly recommended for each wound patient. One diagnosis does not exclude another. Diagnostic delay is especially common in atypical wounds. If the wound does not heal with good standard treatment, the diagnosis should be evaluated again.

Conclusion The literature indicates that while precise wound diagnosis may be easy in theory, it is not always so in practice. Successful wound management implies good collaboration between physicians and tissue viability nurses, and with complicated patient cases, a multidisciplinary approach is mandatory. There is a need for reliable epidemiological research, using clear criteria for wound diagnosis, to estimate the prevalence and incidence of these wounds and also their impact on health, economics and quality of life.

Implications for clinical practice Checklists should be incorporated into clinical prac-

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1. Specialist in Dermatology and Allergology, Helsinki University Central Hospital and Helsinki University, Helsinki Wound Healing Centre 2. Specialist in Vascular Surgery, Helsinki University Central Hospital and Helsinki University, Helsinki Wound Healing Centre 3. Advanced Nurse Practitioner Plastic Surgery, Beaumont Hospital and Royal College of Surgeons in Ireland (RCSI) 4. Specialist in Plastic Surgery, Helsinki University Central Hospital and Helsinki University, Helsinki Wound Healing Centre

Correspondence: kirsi.isoherranen@hus.fi · Conflicts of Interest: None

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tice in wound clinics, and wound diagnosis should be re-analysed at every control point. Negative treatment response should always raise the question whether wound diagnosis is correct.

Key message Determining exact wound aetiology is crucial for successful wound management, and checklists should be incorporated into clinical practice. Clinicians are challenged by the fact that the number of multiaetiological ulcers is increasing, and a multidisciplinary approach is often necessary.

INTRODUCTION A lower-extremity ulcer can be defined as an open lesion on the lower limb due to full thickness skin loss, resulting in chronic wound progression. It is estimated that the prevalence of lower-extremity ulcers is from 1,5 to 2% of the adult population.1,2 This figure is probably underestimated as many studies incorporate only venous leg ulcers. Indeed, a recent study from Wales revealed a prevalence of 6% for chronic wounds at the population level.3 Lower-extremity ulcers cause substantial annual costs and reduced health-related quality of life for the patients so affected.2,4,5 Even if lower-extremity ulcers are more common in elderly people, it has been estimated that 22% of individuals with a leg ulcer have developed

their first venous leg ulcers by 40 years of age and 13% before 30 years of age, thus affecting their ability to work and participate in social activities.6 As lower-extremity ulcers are a symptom of disease, the most important step in achieving successful wound healing is to determine the exact wound aetiology.7,8 However, misdiagnosis due to a lack of systematic assessment of wound patients occurs frequently among health-care providers.9 Multi-aetiological wounds are wounds that have at least two aetiologies, such as arterial and venous, and the increasing number of these multi-aetiological ulcers is a challenge to clinicians.10 In general, the diagnostic process is the physician`s responsibility. However, nurses play an important role as they usually monitor the wounds and the patients for longer, and they are therefore in a position to recognise and respond to delayed healing within a reasonable time frame. In many cases, successful diagnosis requires a multidisciplinary approach. This review intends to give a comprehensive list of the different aetiologies and to suggest tools for healthcare providers when assessing a lower-extremity ulcer patient.

Different aetiologies for lower-extremity ulcers The most common aetiologies for lower-extremity ulcers are venous leg ulcers, diabetic foot ulcers, pres-

Table 1.

Major aetiologies for lower-extremity ulcers and recommended diagnostic procedures

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The major etiologies for lower-extremity ulcers

Diagnostics

Venous leg ulcers

Duplex ultrasonography

Arterial ulcers

Pulse palpation, ankle brachial pressure index, toe pressure, toe brachial index, angiography

Mixed arterial and venous ulcers

Combined diagnostics of venous and arterial ulcers (see above)

Diabetic foot ulcers

Glucose profile, monofilament test, pulse palpation, toe brachial index, angiography

Pressure ulcers

Clinical characteristics, monofilament test

Atypical ulcers

Biopsy but also clinical evaluation, negative histology does not exclude an atypical cause of the ulcer

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Table 2.

Atypical causes of ulcers Atypical ulcer

Possible causes

Vasculitis

Related to rheumatoid arthritis and connective tissue diseases

Pyoderma gangrenosum

Related to inflammatory bowel disease, rheumatoid arthritis and hematologic malignancies

Martorell hypertensive ulcer

Related to hypertension, type II diabetes and warfarin medication

Calciphylaxis

Related to uremic disease

Malignant wounds

Related to age and immunosuppression

Occlusive vasculopathies

e.g. livedoid vasculopathy

Ecthyma gangrenosum

Related to immunosuppression

Artefactal ulcers

Related to personality disorders

Medication-related

e.g. hydroxyurea, methotrexate

Sickle cell disease Infectious

e.g. leishmaniasis, tuberculosis

sure ulcers, arterial ulcers and mixed venous arterial ulcers (Table 1).9,11 It is important to keep in mind that some ulcers may initially occur traumatically, but the healing process may become stalled due to an underlying pathological disease. Therefore, a patient with a traumatic ulcer on the lower extremities should be assessed carefully in order to exclude diseases that would affect acute wound healing. One diagnosis does not exclude another, for example, up to 25% of patients with a venous leg ulcer have concomitant peripheral arterial disease.10 If the wound does not fall into a typical category, has an abnormal location or clinical appearance or does not show healing within three months, an atypical cause should be suspected (Table 2).9,11,12 Physical examination of a lower-extremity ulcer patient Patients should be examined holistically as a careful

history will provide clues for the diagnosis (Table 3).

The use of a standardized checklist is strongly recommended.13 The arterial system should be assessed in every patient, including pulse palpation and measurement of the ankle brachial index. This is also mandatory before the use of compression therapy. The American Diabetes Association has determined that an ankle brachial pressure index (ABPI) of between 0.91–1, is within the normal range, mild peripheral arterial disease is defined as an ABPI of 0.7–0.9, moderate ischemic disease as 0.41–0.69 and critical limb ischemia as ≤ 0.4.14,15 However, ABPI is not reliable in patients with diabetes or in elderly patients. If the pulses are not palpable in diabetic patients or if the suspicion of ischaemia is high in elderly patients, a prompt referral should be made to a specialist for measurement of toe brachial index (TBI) and toe pressure (TP) and for accurate interpretation of the results.

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Table 3.

Patient history and its relevance to lower extremity ulcers Patient history

Potential diagnosis

Primary varicosis or venous thrombosis

Venous leg ulcer

Coronary heart disease, cerebrovascular infarction, smoking

Arterial ulcer

Diabetes

Diabetic foot ulcer, necrobiosis lipoidica, calciphylaxis

Rheumatoid arthritis, connective tissue diasease

Vasculitic ulcers, pyoderma gangrenosum

Inflammatory bowel disease

Pyoderma gangrenosum

Hematologic malignancies

Pyoderma gangrenosum

Uremic disease

Calciphylaxis

Medication: hydroxyurea, warfarin

Hydroxyurea-ulcers, warfarin necrosis, Martorell hypertensive ulcers, calciphylaxis

Travel history, immunosuppression

Leishmaniasis, tuberculosis, malignant ulcers, ecthyma gangrenosum

Psychological factors, personality disorders

Patient concordance, artefactal ulcers

Obesity

Venous leg ulcers, calciphylaxis

Patients should also undergo testing for peripheral neuropathy with a 10-g monofilament, ankle range of motion and a nutritional evaluation. Inspection of possible sources of pressure and pressure sites should be routine. It is also important to assess the wound bed, wound borders, surrounding skin and both legs, including skin between the toes, foot soles and heels. If the wound shows atypical signs and/ or does not show sufficient healing tendency during 4–12 weeks it should be biopsied.11 This is especially important as the prevalence of malignant wounds is increasing and, at first sight, they can appear to be ordinary wounds.16,17 After these examinations, the wound should be assessed using the TIME model.18 All wounds should be examined with a probe and a positive probe-to-bone result is a marker of osteomyelitis and probable diabetic foot ulcer infection.19

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Venous leg ulcers Venous leg ulcers are the most common lowerextremity ulcers, comprising up to 60–70% of all chronic ulcers.1,6 The cause is either primary venous insufficiency or post-thrombotic syndrome. However, swelling due to other causes can result in similar ulcers.20 Specific comorbidities to be taken into account include peripheral vascular disease, diabetes, hypertension, obesity, trauma, impaired mobility and malnutrition.1 The clinical picture is usually easy to recognize, especially when assessing the peri-wound skin (Figure 1). Skin changes related to chronic venous hypertension include eczema, hyperpigmentation caused by hemosiderin deposits, induration of the skin and the underlying tissue (dermatoliposclerosis) and visible capillaries around the ankle (coronaria phlebotactica).The majority of venous leg ulcers are located around the medial ankle, but some are located on the lateral or dorsal aspect of the foot.8,21

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Figure 1. A venous leg ulcer in a 71 year old man in the lateral malleolar region.

Figure 2. An arterial ulcer in a 69 years old woman in the left calf.

Figure 3. Mixed venous and arterial ulcers in a 84 years old man.

Figure 4. A vasculitic ulcer in the ankle region of a 22 year old man.

Venous leg ulcers are usually moderately to highly exudating and contain fibrinous slough, but bacterial infection is uncommon. Therefore, in the absence of clinical signs of infection, bacterial swabs are not routinely recommended.1

not uncommon (Figure 3). In these cases, the clinical suspicion is important and a thorough arterial and venous evaluation should be performed.22

Arterial ulcers Peripheral arterial disease should always be the first exclusion diagnosis in all lower-extremity ulcers, together with severe infection. Frequent comorbidities include diabetes, coronary heart disease and cerebrovascular disease.1 Smoking is a major risk factor. Arterial ulcers comprise about 15â&#x20AC;&#x201C;20 % of all leg ulcers.

They are typically deeper, drier and more necrotic than venous leg ulcers (Figure 2). Toes, feet and heels are the most frequent locations, but any other location is possible.9 Prompt diagnosis of an arterial ulcer is important in order to avoid amputation.

Mixed venous arterial leg ulcers Mixed arterial venous disease is estimated to affect up to 26% of patients with lower extremity ulcerations, however their pathophysiology is not well studied.22 Mixed venous arterial ulcers usually combine the clinical characteristics of venous leg ulcers and arterial ulcers. They are located in the medial or lateral aspects of the leg, and circumferential extension is

Diabetic foot ulcers Diabetic foot ulcers are the most common foot ulcers, and the lifetime risk of a diabetic patient developing a foot ulcer is approximately 25%.23 For this reason, the glucose profile of a patient with a foot ulcer should always be evaluated. The pathophysiology of diabetic foot ulcers includes peripheral neuropathy and peripheral arterial disease. Approximately 50% of diabetic foot ulcers occur in the toes or web spaces.

The other 50% of ulcers are plantar in the forefoot, midfoot or heel.24 In addition, the peri-wound skin often contains hyperkeratotic skin called callus, and this is a typical sign of a diabetic neuropathic ulcer.25 In diabetic foot ulcer patients it is important to consider whether the patient is in need of urgent hospital admission for an ischaemic or infected diabetic foot.

Pressure ulcers Pressure ulcers develop most commonly on bony prominences as a result of pressure or pressure in combination with shear stress.26 Typical locations of pressure ulcers in the lower-extremities are the heels, the malleolar region and the toes. Risk factors include

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Figure 5. A Pyoderma gangrenosum ulcer in a 26 years old woman.

Figure 6. A Martorell ulcer in the right leg of a 70 years old woman who had diabetes and hypertension.

Figure 7. An eczematized basalioma in a 77 years old man.

Figure 8. Livedoid vasculopathy ulcers in the ankle region a 50 years old woman (notice atrophie blanche around the ulcers)

peripheral arterial disease, limited mobility, diabetes, rheumatoid arthritis and forefoot deformity.8,9,26,27

of a systemic vasculitis (e.g. cutaneous PAN or cutaneous arteritis), or iii) a single organ vasculitis (SOV) of the skin.28 The clinical picture of cutaneous vasculitis includes palpable and retiform purpura, livedo racemosa and necrotic ulcers (Figure 4).

Atypical causes of leg ulcers The prevalence of atypical ulcers (Table 2) has previously been underestimated, but a recent document estimates that they comprise up to 20% of all chronic wounds.11 Many of them probably remain undiagnosed, and it is important that every health-care professional treating chronic wounds is aware of this possibility and recognizes when to refer the patient on to a specialist (e.g. a dermatologist). Recognizing atypical ulcers is also important because many of them are worsened by debridement or surgical revision before starting with, for example, immunosuppressive therapy.11 Vasculitic ulcers occur due to an inflammatory process, which leads to the destruction of the walls of blood vessels. The ulcers result from ischaemic necrosis of the vessels.11 Cutaneous vasculitis, occurring as vasculitic ulcers, can be classified as: i) a cutaneous component of a systemic vasculitis (e.g. cutaneous manifestations of polyarteritis nodosa; PAN), ii) a skin-limited or skin-dominant expression or variant

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Pyoderma gangrenosum (PG) is a neutrophilic disease of the skin, and it is associated with inflammatory bowel disease, rheumatoid arthritis and hematologic malignancies.11 A PG lesion starts typically as a pustule and rapidly evolves into a painful ulcer with superficial necrosis and violaceous borders (Figure 5). It is important not to debride these ulcers before starting with immunosuppressive therapy as they exhibit the pathergy phenomenon whereby they are exacerbated by trauma.11 PG can also occur after surgery, especially after breast surgery.29,30 Martorell hypertensive ulcers and calciphylaxis are both diseases that share common pathophysiology: subcutaneous arteriolosclerosis.31 Martorell hypertensive ischaemic leg ulcer is associated with type II diabetes, hypertension and vitamin K antagonists, and the typical location is the laterodorsal leg and the Achilles tendon.11,31 The ulcers are painful, rapidly

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growing and often have a narrow red band around the wound borders (Figure 6). Calciphylaxis is associated with chronic renal insufficiency and obesity and is divided into distal and proximal patterns.11 Both Martorell hypertensive ulcers and calciphylaxis can be lethal.31,32 Malignant wounds are increasing with an aging population, and in a prospective multicentre study in which all included patients with non-healing chronic leg ulcers were biopsied, malignant wounds showed a prevalence of as high as 10.4%.33 The diagnosis can be substantially delayed as a malignant wound can look like a chronic leg ulcer of any other cause.

Signs of a malignant wound include atypical ulcer location, hypergranulation, irregular wound borders, wound odour, increased wound pain and bleeding of the wound (Figure 7).11,33 Any leg ulcer that does not show sufficient healing tendency in the course of 4–12 weeks should be biopsied in order to exclude malignancy.11 Occlusive vasculopathy may be defined as a blood vessel disorder mainly characterised by a diminishment or even complete occlusion of the vessel lumina, and occlusive vasculopathies can be divided into three major groups: embolization, intravascular thrombi and coagulopathies.11 One form of coagulopathy is livedoid vasculopathy, which presents as recurrent, painful ulcers around the ankles and typically, affects middle-aged women (Figure 8). The pathophysiology of ulcers in sickle cell disease is not well known, but vasculopathy probably plays a major role.34

Artefactal ulcers are associated with personality disorders and display geometric or other unusual patterns, with sharply demarcated edges and they spare anatomic areas that are difficult to reach.11 Artefactal ulcer is a diagnosis of exclusion.11,35 Ecthyma gangrenosum is a cutaneous manifestation of bacterial infection, especially of Pseudomonas aeruginosa. It affects especially immunocompromised patients and presents with erythematous or purpuric macules that rapidly evolve into vesicles or nodules and subsequently into ulcers with a black eschar formation and a surrounding erythematous halo.11 Medications such as hydroxyurea, methotrexate and nicorandil can also cause lower-extremity ulcers.

Leishmaniasis, tuberculosis and other infections, as well as a variety of dermatological conditions are also causes of atypical wounds.11,12 CONCLUSION Common causes of lower-extremity ulcers are relatively easy to diagnose, but exact wound diagnosis needs always a holistic approach and a careful evaluation of the wound patient. Systematic assessment and the use of check-lists provides diagnostic tools, for example, for multiaetiological wounds, as one aetiology does not exclude another. In addition, tissue viability nurses play a crucial role as they can usually monitor lower-extremity ulcer patients for longer, and they can refer the patient to a specialist if suspicion of a wrong first diagnosis arises. A ‘wait and see’ attitude can lead to devastating outcomes.

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REFERENCES 1. Franks P, Barker J, Collier M,Gethin G, Haesler E, Jawien , et al. EWMA document; Management of patients with venous leg ulcer: Challenges and current best practice. Journal of Wound Care 2016; (25), Suppl, 1–67.

14. Crawford F, Welch K, Andras A, Chappell FM. Ankle brachial index for the diagnosis of lower limb peripheral arterial disease. Cochrane Database Syst Rev. 2016; 9:CD010680. https://doi. org/10.2174/157340308784245810.

2. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons N. Burden of venous leg ulcers in the United States. J Med Econ 2014; 17 (5):347– 56.

15. Rajabi-Estarabi A, Kayssi A, Alavi A, Kirsner RS. Vascular tests for dermatologists. Am J Clin Dermatol 2019. https//doi.org./10.1007/s40257-019-00441-x

3. Phillips CJ, Humphreys I, Fletcher J, Harding K, Chamberlain G, Macey S. Estimating the costs associated with the management of patients with chronic wounds using linked routine data. Int Wound J 2015; doi:10.1111/iwj.12443.

4. Lindholm C, Searle R. Wound management for the 21st century: Combining effectiviness and efficiency. Int Wound J 2016; (13):5–15.

5. Platsidaki E, Kouris A, Christodoulou C. Psychosocial aspects in patients with chronic leg ulcers. Wounds 2017; 29(10):306–310.

6. Alavi A, Sibbald G, Phillips TJ, Miller F, Margolis DJ, Marston W, et al. What`s new: Management of venous leg ulcers. J Am Acad Dermatol 2016; (74):627–40.

7. Mooij MC, Huisman LC. Chronic leg ulcer: Does a patient always get a correct diagnosis and adequate treatment? Phlebology 2016; (13):68–73.

8. Singer AJ, Tassiopoulos A, Kirsner RS. Evaluation and management of lower-extremity ulcers. N Engl J Med 2017; (169):1559–1567.

9. Kirsner RS, Vivas AC. Lower-extremity ulcers: Diagnosis and management. Brit J Dermatol 2015; (173):379–390.

10. O`Donnell TF, Passman MA, Marston WA, Ennis WJ, Dalsing M, Kistner RL,et al. Management of venous leg ulcers: Clinical practice guidelines of the Society for Vascular Surgery and the Americal Venous Forum.

J Vasc Surg 2014; (60):3S–59S. 11. Isoherranen K, Jordan O`Brien J, Barker J, Dissemond J, Hafner J, Jemec BE, et al. EWMA Document; Atypical wounds: Best clinical practices and challenges. J Wound care 2019 Jun 1;28(Sup6):S1S92.

12. Hoffman MD. Atypical ulcers. Dermatol Ther 2013; (26):222–235.

13.Snyder RJ, Jensen J, Applewhite AJ, Couch K, Joseph WS, Lantis Ii JC, et al. A standardized approach to evaluating lower extremity chronic wounds using a checklist. Wounds 2019; 31:S29–S44.

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16. Gao W, Chen D, Ran X. Malignant melanoma misdiagnosed as diabetic foot ulcer. Medicine 2017; (96):29.

17. Torrence G, Wrobel JS. A case of mistaken identity: Classic Kaposi sarcoma misdiagnosed as a diabetic foot ulcer in an atypical patient. Clin Diabetes Endocr 2019; (5):8.

18. Schultz G, Mozingo D, Romanelli M, Claxton K. Wound healing and TIME; New concepts and scientific applications. Wound Repair and Regeneration 2005; (13):S1–S11.

19. Mavrogenis AF, Megaloikonomos PD, Antoniadou T, Igoumenou V, Panagopolus GN, Dimopoulos L, et al.

Current concepts for the evaluation and management of diabetic foot ulcers. Efort Open Reviews 2018; (3):513–525.

20. Ratchford EV, Evans NS. Approach to lower extremity edema. Curr Treat Options Cardio Med 2017; (19):16.

21. Hafner J, Ramelet AA, Schmeller W, Brunner UV. Management of venous leg ulcers. Current Probl Dermatol 1999; (27):4–7.

22. Hedayati N, Carson JG, Chi Y-W, Link D. Management of mixed arterial venous lower extremity ulceration: A review. Vascular Medicine 2015; 20(5):479–486.

23. Reiber GE. The epidemiology of diabetic foot problems. Diabet Med 1996; 13(Suppl. 1):S6–11.14 S. 24. Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, et al. High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia 2007 Jan; 50(1):18–25.

25. Arosi I, Hiner G, Rajbhandari S. Pathogenesis and treatment of callus in the diabetic foot. Curr Diabetes Rev 2016; 12(3):179–183.

26. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, Haesler E, editor. Prevention and treatment of pressure ulcers: Quick reference guide.

Cambridge Media: Osborne Park, Western Australia; 2014. 27. Siddle HJ, Firth J, Waxman R, Nelson EA, Helliwell PS. A case series to describe the clinical characteristics of foot ulceration in patients with rheumatoid arthritis. Clin Rheumatol 2012; (3):541–545.

28. Sunderkötter CH, Zelger B, Chen KR, Requena L, Piette W, Carlson JA, et al. Nomenclature of cutaneous vasculitis: Dermatologic addendum to the 2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides. Arthritis Rheumatol, 2018; (70) 171–184.

29. Zuo KJ, Fung E, Tredget EE, Lin AN. A systematic review of postsurgical pyoderma gangrenosum: Identification of risk factors and proposed management strategy. J Plast Reconstr Aesthet Surg 2015; 68(3):295–303. https://dx.doi.org/10.1016/j. bjps.2014.12.036.

30. Isoherranen K. Post-surgical pyoderma gangrenosum: A retrospective analysis of four clinical cases. EWMA Journal 2019; (20):37–40.

31. Hafner J, Nobbe S, Partsch H, Läuchli S, Mayer D, Amann-Vesti B, et al. Martorell hypertensive ischemic leg ulcer: A model of ischemic subcutaneous arteriolosclerosis. Arch Dermatol 2010; 146(9):961– 968. https://dx.doi.org/10.1001/archdermatol.2010.224 32. Nigwekar SU, Thadhani R, Brandenburg VM. Calciphylaxis. N Engl J Med 2018; 378(18):1704– 1714. https://dx.doi.org/10.1056/NEJMra1505292 33. Combemale P, Combemale P, Debure C, Baudot N, Machet L, Aout M, et al. Malignancy and chronic leg ulcers: The value of systematic wound biopsies: A prospective, multicenter, cross-sectional study. Arch Dermatol 2012; 148(6):704–708. https://dx.doi. org/10.1001/archdermatol.2011.3362 34. Minniti CP, Kato GJ. Critical reviews: How we treat sickle cell patients with leg ulcers. Am J Hematol 2016; 91(1): 22–30.

35. Conde Montero E, Sánchez-Albisua B, Guisado S, Angeles-Martin-Diaz M, Balbin-Carrero E, Valdivelsoramos M, de la Cueva Dobao P. Factitious ulcer misdiagnosed as pyoderma gangrenosum. Wounds 2016; 28(2):63–67.

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DOI: 10.35279/jewma202011.09

Jacques Oskam MD PhD¹, Annemiek Stienstra RN NP Msc² ¹ Wound Expertise Centre, Department of Surgery, Isala, Zwolle, The Netherlands ² QualityZorg, Nieuw-Vennep, The Netherlands

Community-based wound care in the Netherlands: Implementing a regional network for wound care The transition of hospital care to primary care is one of the mainstays of national health care policy in the Netherlands. This paper presents the results of a successful initiative to establish a regional community-based wound care network in the Zwolle region of the Netherlands.

Keywords:

community-based; complex wounds; network medicine; nurse practitioner; organisational innovation; primary care; regional network; wound care team; wound expertise centre

ABSTRACT Background The transition of hospital care to primary care is one of the mainstays of national health care policy in the Netherlands. After introducing an innovative new concept of wound care in 2015, this successful initiative expanded to a regional community-based wound care network in the Zwolle region.

Method A descriptive analysis of several outcome parameters was performed on prospectively retrieved data. In the period 2018–2019, a weekly consultation hour was started after installing a local team in six primary care practices. The team included a nurse practitioner specialised in wound care, general practitioner assistants and a general practitioner. An experienced surgeon from the regional hospital could be consulted via telemedicine and visited the practices regularly.

Findings In total, 869 patients were seen; among them, 695 patients had 814 wounds. Most of these wounds (73%) were located on a lower extremity. The program treated mainly older patients with moderate or

severe co-morbidities; 91% were served in a primary care practice. An access time of up to six weeks was reported for 80% of patients. A healing rate of 91% was achieved in 417 wound patients treated by the nurse practitioner. In the end, 9% of the cases were referred to the regional hospital.

Conclusions Almost all patients with wound-related problems can be served by a local nurse practitioner-led team. It seems that the Zwolle regional wound care network has adopted the national policy goals, such as short access times and more preventative measures, with high rates of wound healing and a minimum number of referrals.

In the Netherlands, national guidelines were developed in 2018 with the goal of implementing basic conditions to ensure good care outcomes and a good organisation of wound care.1 These guidelines state that wound care comprises more than the application of bandages or medical supplies by paramedics; instead, wound care is a medical domain that needs to be performed with medical expertise by well-trained care professionals. In this view, doctors should most-

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Correspondence: j.oskam@isala.nl · Conflicts of Interest: None

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ly facilitate other wound professionals’ work; their primary responsibility is ensuing that quality care is being provided. The purpose of the guidelines is to deliver wound care closer to the patient’s community and to realise a decrease in the number of referrals to the hospital, thus minimising health care expenditures.

We have already reported that, in the Netherlands, intensive and complex wound care can be performed in local general practices with good outcomes and at minimal costs.2 The outcomes were so positive that we decided to implement the model on a wider regional scale. One of the advantages of the care concept is that fewer patients are referred to hospital care, because they can receive almost all the wound care they need in their own community. The wound care is performed by a nurse practitioner who specialises in wounds, working in co-operation with a local team of general practitioners and general practitioner assistants. The care model that functions locally can be linked together perfectly to a regional wound care network. Thus, high quality wound care is within reach of a local community, with the best clinical results and at the lowest cost.3 Key messages • This paper presents the results of a successful initiative to establish a regional community-based wound care network in the Zwolle region of the Netherlands. The cohort study’s organisation, set up and requirements are outlined. Data were col lected concerning patients’ age, sex, wound location, wound age, wound healing, comorbidi ties, outcomes of consultation and aspects of their referral to the hospital.

• The aim of this paper is to share the results of efforts to organise wound care in a general practice setting and to demonstrate the benefits for patients and the Dutch health care system alike.

• By organising wound care in a general practice setting managed by a local team headed by a nurse practitioner who specialises in wound care, about 90% of the wounds healed without a referral to the regional hospital.

• Access time was less than six weeks for 80% of the patients; mainly older patients with moderate or severe co-morbidities were treated.

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METHOD In 2018, we commenced a weekly consultation hour for primary care practices in the Zwolle region of the Netherlands. Between February 2018 and September 2019, six general practitioner centres participated in the wound care network. These six practices served a population of about 53,000 people as of May 2020.

We performed a cohort study in which prospectively retrieved data were used. A descriptive analysis was performed related to patients’ age, sex, wound location, wound age, wound healing, comorbidities, outcomes of consultation and aspects of their referral to a hospital.

A local wound team was established and composed of a nurse practitioner, general practitioner assistants and a general practitioner. A strong collaboration with local home-care service nurses was also established from the beginning. A surgeon from the Wound Expertise Centre (WEC) Isala Zwolle could be consulted via telemedicine. Surgeons from the WEC visited the local wound teams every six weeks to participate in consultations regarding more complex cases at the site, in order to minimise referrals to the hospital. There were no other locally involved medical specialties. The nurse practitioner could also visit patients in their homes, if they were unable to come to the general practice. The local wound team also cooperated with other primary care professionals, including physical therapists, oedema therapists, chiropodists, podiatrists or an orthopaedic shoemaker.

Only when necessary were patients referred to the hospital for specific diagnostic purposes or treatments, such as the application of lower limb casts or operative treatments.

The wound teams reported all relevant information via electronic patient files. During the consultation hour, the nurse practitioner could make use of all instruments to perform surgical debridement. Anklebrachial-index and toe-pressure were performed with an automated kit. Additional diagnostics used by the nurse practitioner concerned skin biopsies, wound swabs or blood tests. Radiological diagnostics could be ordered at the hospital in Zwolle, so that the local wound team maintained its leadership over the case. Wound photos taken with a 2D-camera and particular dimensions of the wound were also measured every week.

Since the nurse practitioner was the only wound careeducated member of the team, a specific education

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programme was the mainstay of the implementation strategy. All local wound teams were trained by the nurse practitioner in wound biology, diagnostics and treatments, such as debridement and compression therapy. Educational materials were developed in collaboration with the WEC Isala. Furthermore, all general practitioner assistants in the Zwolle region were trained four times per year in a regional meeting led by wound professionals from the WEC. The general practitioner did not follow a specific education programme, but learned by doing while collaborating weekly with the nurse practitioner. General practitioners also participated when the surgeon was visiting the practice, every 4–6 weeks. Wound-educated nurses employed by the home care services were also invited to join the educational programme locally.

A special wound electonic medical record (EMR) system, along with process-information technology and data models, was developed for the project, and the data were entered using specially developed software. The relevant information was discussed every eight weeks in a special meeting with the WEC and the nurse practitioners. The general practice management and local wound team were visited twice annually by the project leaders to evaluate and discuss management information and the outcomes of the

wound care provided. In addition, costs related to the outcomes of care were also monitored, in order to quantify the added value of the care process. The number and duration of visits, home visits, specific interventions performed and bandages and medical supplies used were registered.

Reimbursement was based on a production-related system, not on a patient-dependent budget. The pay-

Table 1.

Localisation of 815 wounds Location

Left

Right

Total

Other

14%

13%

27%

Upper leg

1%

2%

3%

Lower leg

18%

17%

35%

Ankle

3%

3%

7%

Heel

2%

2%

5%

Midfoot

1%

1%

2%

Forefoot

3%

3%

6%

Toes

8%

9%

16%

Total

51%

49%

Figure 1.

Distribution of patients by age and sex (n=869) Male

Female

90+

2%

80-89

10%

17%

70-79

12%

12%

60-69

9%

7%

50-59

6%

4%

40-49

2%

2%

30-39 20-29

6%

1%

1%

2%

2%

10-19

1%

1%

0-9

1%

0,5% 

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Table 2.

Distribution of the absolute number of registered secondary diagnoses per location in a total of 869 patients. Note that patients may suffer from more than one secondary diagnosis.

Foot n=252, Lower leg n=365, Upper leg n=26, Other locations n= 226 Diagnosis

Foot

Location

Lower leg Upper leg

Total

Other

Diabetes

88

54

3

40

185

PAOD

56

43

3

13

115

Venous disease

58

99

4

20

181

Heart disease

164

171

12

104

451

Neurological disease

50

37

3

26

116

Lung disease

33

52

4

33

122

Renal disease

53

44

2

16

115

Malignancy

30

30

5

26

91

Immune-deficiency

28

35

2

13

78

Total

560

565

38

291

1454

PAOD, Peripheral Arterial Occlusive Disease ments for, respectively, the general practise, the nurse practitioner, the consulting surgeon and home care services were all made separately. Particular financial settlements and project subsidies were arranged by the regional insurance company in cooperation with the regional hospital for the duration of the programme’s three years.

RESULTS A total of 869 patients were seen by the local wound teams during the observation period. This means that about one percent (1.3%) of the local population received treatment for a wound-related problem during the study period. The 869 people together had a total of 814 wounds. Figure 1 shows that the greatest number of patients were over 50 years of age. The male–female distribution was about equal.

The localisation of the wounds can be seen in Table 1. What stands out is that 42% of the wounds were localised to the lower leg, while about 29% had a foot wound. In the foot, the toes were most often affected. The category ‘other wounds’ (27%) comprised wounds of the head, arms, trunk or buttocks. Pressure sores were seen only in 17 patients (2%).

The distribution of secondary diagnoses in relation to location is displayed in Table 2. Cardiac-related disorders were, by far, in the majority and concerned 31%

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of all diagnoses. Heart disease predominated mainly in foot and lower leg wounds. Venous disease was also manifest in lower leg ulcers, while all the other disorders were equally distributed. Diabetes was present

Figure 2.

Pie chart with distribution of comorbidities

16%

39%

45%

None

Mild

Severe

Note: ‘None’ means no comorbidity, ‘Mild’ means 1 or 2 secondary diagnoses, ‘Severe’ means 3 or more secondary diagnoses.

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Figure 3.

Distribution of wound age, from the origin of the wound (n = 815) 2%

1% 2%

Figure 4.

Overview of outcomes of consultations performed by the community wound team in the primary care setting (n=869 patients)

5%

5%

10%

12%

44% 20% 80%

2%

9% 8%

4%

0-6 weeks

7 weeks - 3 months

4-6 months

7-12 months

Wound healed solely in our primary care setting

more than 1 year

unknown

Chronic wound treated solely in our primary care setting Referred - to other primary care

in patients with foot and lower leg wounds. Diabetes was present in about one third of foot wounds (35%).

Peripheral arterial occlusive disease was associated with foot wounds in 22% of cases, but it was also present in 12% of lower leg wounds.

An overview of the severity of related co-morbidities can be seen in Figure 2. Roughly 39% of the patients were healthy and had no secondary diagnosis, while all other patients did have a co-morbidity (61%). A substantial group, 16%, had three or more secondary diagnoses and suffered from a severe co-morbidity.

Figure 3 shows that 80% of the patients came to the wound consultation hour within six weeks of the origination of their wound-related problem. Almost all (90%) of the patients visited the wound team within a period less than three months. In only 5% of patients had the wound been present for more than six months.

In total, 695 patients with a wound problem were seen, and in a selection of 417 (61%) of more complex cases, both diagnosis and wound treatment were performed under supervision of the nursing prac-

Refferred - to hospital Patient passed away Only preventive care solely in our primary care setting Not (yet) known

titioner. Eventually, complete healing was achieved in 397 patients (healing rate: 91%). In 9% of cases, the wound remained chronic, but progress was made leading to fewer complaints or less discomfort. In 28% of the 869 patients, the local wound team only performed diagnostic activities or proposed a plan for treatment. Further care was performed by colleague primary care partners in the community. The group with an unknown consultation outcome (12%) refers to those patients who were not registered with the concerning general care practice, or who were later seen by other care professionals.

Referral to the WEC was eventually deemed necessary in 9% of patients (see also Table 3). A majority of referrals to the WEC concerned foot wounds. Additional diagnostic procedures, such as duplex ultrasounds or complex radiologic tests, were done. Most

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Table 3.

Overview of the 71 patients referred to the multidisciplinary Wound Expertise Centre at Isala Hospital.

Wound Expertise Centre

Foot

Lower leg

Upper leg

Other

Total

24

19

3

5

51 20

Hospital Admissions

15

4

-

1

Vascular intervention

12

2

-

-

Minor amputation

11

-

-

-

Conservative

3

2

-

1

Major amputation

-

-

-

-

33

18

2

3

Wounds Healed

56

Note: A total of 56 patients out of 71 referred patients (79%) eventually healed during the observation period.

lower leg patients were referred to dermatologists to analyse and treat ulcers for vasculitis or other specific dermatological diagnoses. Hospital admission was necessary in 20 patients. The main goal of treatment was conservative infection treatment or limb salvage by performing vascular procedures or foot surgery.

Fortunately, no major amputations have been performed to date.

DISCUSSION We report on the experiences with this programme two years after we formed a regional network for complex wound care in the region of the Dutch city of Zwolle (450,000 inhabitants). The project began in 2018 in the primary care setting for about 33,000 residents of three local communities. At present, we have expanded to six towns and serve a population of 53,000 people. The results show that more than 90% of patients could be treated in the primary care setting with a high quality outcome. Many patients were elderly people with lower extremity wounds, and most were seen within six weeks after the initiation of the wound. We know from earlier reports that, in the Netherlands, the average access time for wound care is more than 30 weeks.4 The local team was able to serve more than 90% of patients in the community. With this in mind, we can conclude that we have already improved the accessibility of wound care in the Zwolle region.

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Another positive observation we made is that the number of referrals to the hospital was just 9%. This is a number three times lower than the Dutch average of 30% mentioned in a national report dating from 2014.4 Still, most wounds healed in the hospital setting with only a minimum of hospitalisation and invasive interventions. The healing rate of selected wounds was 91% with the local wound team and 79% in the hospital setting. This is a rate above the international standard of 75% for wound healing.

In conclusion, it appears that the quality indicators for outcomes of wound care are at a good level in our region.

The first step to establishing a working wound care service was the formation of local dedicated wound teams directed by the regional WEC. The nurse practitioner fulfils a central role in the team as a ‘wound navigator’.5 This professional was trained in complex wound care in the WEC and has more knowledge of wounds than is available from generalist professionals locally. Together with the general practitioner, the nurse practitioner could shape the medical policy and ensure access to the WEC. Furthermore, the nurse practitioner linked other local care professionals together to an organised wound team. The medical leadership, education and quality guarantee were taken care of in the regional WEC. In fact, the network may be considered a virtual multi-professional and multidisciplinary wound team, a notion proposed

by EWMA in 2014.5

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It has already been discussed in the EWMA community that good working wound care stands on three prerequisites, financial preconditions, educational preconditions and organisational preconditions.5 In our opinion, the most important message of the EWMA position paper is that modern care for wounds demands wound education and sound therapeutic skills organised in multidisciplinary and multiprofessional teams. The latter may imply that wound care is not best performed by generalist health care professionals in primary care or home care services.

Therefore, we came up with the concept of introducing wound-educated nurse practitioners in primary practice settings to strengthen wound care in the community. In this paper, we discuss how we dealt with system constraints and we addressed the three prerequisites mentioned above. This study shows that considerable quality improvement can be achieved with a local team in which the nurse practitioner is the only wound-educated professional. Thus, this network succeeded in pursuing the best achievable level of wound care in the Dutch health care system.

healing rates within primary care practices. It seems that the Zwolle regional wound care network established national policy goals, such as short access time and more preventative measures, which led to high rates of wound-healing and a minimum of referrals to the hospital.

CONCLUSION The most important finding of this study is that almost all patients with wound-related problems can be served by a local team in their own community. Furthermore, introducing a wound-trained nurse practitioner in a local team leads to good quality wound care, not only for patients suffering from wounds but also in terms of preventive care. Moreover, the results provide epidemiologic insight into wound-

• Specific e-health applications to support wound patients with self-management and empowerment

Recommendations for clinical practice For future success and the securing of other regional wound network initiatives, we think that future investments and research should focus on: • Educating nurse practitioners and local caregivers for the wound team • A specific information and communication tech nologies (ICT data) model to monitor outcomes and costs, to optimise health economic value in the whole chain of wound care • A new financial model that covers all care activities and medical supplies, to ensure fair reimbursement

Acknowledgements We gratefully thank Mr Pieter van den Berg and Mrs Marja Zwaan for their advice and support while implementing the regional network.

REFERENCES 1. Meerwaldt, R, Das, F, Fentener van Vlissingen, J, de Lange, E, Maessen-Visch, B, Oskam, J, et al. Kwaliteitsstandaard organisatie van wondzorg in nederland (Organisation of wound care in the Netherlands). Utrecht: Nederlandse Vereniging voor Heelkunde; 2018. p. 1–86.

2. Amesz, S, Monsma, M, Corporaal, G, Oskam, J. Betere wondzorg bij de huisarts (Better woundcare in the general practice). Medisch Contact 2018 Nov; 45:20–3.

3. Netherlands, Government, Department of Health. De Juiste Zorg op de Juiste Plek: Wie Durft? (appropriate care at the appropriate place: who dares?). Den Haag: VWS; 2018 Apr. 104 p.

5. Moore, Z, Butcher, G, Corbett, LQ, et al.

AAWC, AWMA, EWMA position paper: Managing wounds as a team. J Wound Care 2014; 23(5 Suppl.):S1–38

4. Netherlands, Capgemini Consulting. Innovatie van Complexe Wondzorg: onderzoek naar potentiële besparingen en prestatieomschrijvingen (Innovation of complex wound care: Exploration of potential savings and performance definitions). Utrecht: Capgemini consulting; 2014 May.

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51% more 1* closed wounds PICO◊ sNPWT† has been shown to significantly reduce wound area and depth when compared with tNPWT‡ in patients with VLUs and DFUs over 12 weeks.1 Turn around wound healing trajectory more effectively than standard dressings and tNPWT with PICO.2

PICO◊ 14

Single Use Negative Pressure Wound Therapy System

Helping you get CLOSER TO ZERO◊ delay in wound healing smith-nephew.com/pico References: 1. Kirsner R, Dove C, Reyzelman A, Vayser D, Jaimes H. A prospective, randomized, controlled clinical trial on the efficacy of a single-use negative pressure wound therapy system, compared to traditional negative pressure wound therapy in the treatment of chronic ulcers of the lower extremities. Wound Rep Regen. 2019. May 14 https://doi.org/10.1111/wrr.12727.

2. Dowsett C, et al. Use of PICO◊ to improve clinical and economic outcomes in hard-to-heal wounds.

Wounds International. 2017;8, p53–58. *45 vs 22%; p=0.002; ITT population. † Single Use Negative Pressure Wound Therapy (sNPWT). ‡ Traditional Negative Pressure Wound Therapy (tNPWT). ◊Trademark of Smith & Nephew. All Trademarks acknowledged. ©October 2019 Smith & Nephew.

AWM-AWD-20619 | GMC0897b

COCHRANE REVIEWS

Cochrane Wounds Group Reviews and Review Updates Publication in The Cochrane Library Issue 8, 2019

Selection criteria: We included randomised controlled trials (RCTs) that compared chlorhexidine bathing with soap-and-water bathing of patients in the ICU.

Chlorhexidine bathing of the critically ill for the prevention of hospital-acquired infection

Data collection and analysis: Two review authors independently assessed study eligibility, extracted data and undertook risk of bias and GRADE assessment of the certainty of the evidence .

Sharon R Lewis, Oliver J Schofield-Robinson, Sarah Rhodes, Andrew F Smith

Main results: We included eight studies in this review.

Four RCTs included a total of 1537 individually randomised participants, and four cluster-randomised crossover studies included 23 randomised ICUs with 22,935 participants. We identified one study awaiting classification, for which we were unable to assess eligibility.

Citation example: Lewis SR, Schofield-Robinson OJ, Rhodes S, Smith AF. Chlorhexidine bathing of the critically ill for the prevention of hospital-acquired infection.

Cochrane Database of Systematic Reviews 2019, Issue 8.

Art. No.: CD012248. DOI: 10.1002/14651858.

CD012248.pub2.

ABSTRACT Background: Hospital-acquired infection is a frequent adverse event in patient care; it can lead to longer stays in the intensive care unit (ICU), additional medical complications, permanent disability or death. Whilst all hospital-based patients are susceptible to infections, prevalence is particularly high in the ICU, where people who are critically ill have suppressed immunity and are subject to increased invasive monitoring. People who are mechanically-ventilated are at infection risk due to tracheostomy and reintubation and use of multiple central venous catheters, where lines and tubes may act as vectors for the transmission of bacteria and may increase bloodstream infections and ventilator-associated pneumonia (VAP). Chlorhexidine is a low-cost product, widely used as a disinfectant and antiseptic, which may be used to bathe people who are critically ill with the aim of killing bacteria and reducing the spread of hospital-acquired infections.

Objectives: To assess the effects of chlorhexidine bathing on the number of hospital-acquired infections in people who are critically ill.

Search methods: In December 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus.

We also searched clinical trial registries for ongoing and unpublished studies, and checked reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

The studies compared bathing using 2% chlorhexidineimpregnated washcloths or dilute solutions of 4% chlorhexidine versus soap-and-water bathing or bathing with non-antimicrobial washcloths.

Eight studies reported data for participants who had a hospital-acquired infection during the ICU stay. We are uncertain whether using chlorhexidine for bathing of critically ill people reduces the rate of hospital-acquired infection, because the certainty of the evidence is very low (rate difference 1.70, 95% confidence interval (CI) 0.12 to 3.29; 21,924 participants). Six studies reported mortality (in hospital, in the ICU, and at 48 hours). We cannot be sure whether using chlorhexidine for bathing of critically-ill people reduces mortality, because the certainty of the evidence is very low (odds ratio 0.87, 95% CI 0.76 to 0.99; 15,798 participants). Six studies reported length of stay in the ICU. We noted that individual studies found no evidence of a difference in length of stay; we did not conduct meta-analysis because data were skewed. It is not clear whether using chlorhexidine for bathing of critically ill people reduced length of stay in the ICU, because the certainty of the evidence is very low. Seven studies reported skin reactions as an adverse event, and five of these reported skin reactions which were thought to be attributable to the bathing solution.

Data in these studies were reported inconsistently and we were unable to conduct meta-analysis; we cannot tell whether using chlorhexidine for bathing of critically ill people reduced adverse events, because the certainty of the evidence is very low.

We used the GRADE approach to downgrade the certainty of the evidence of each outcome to very low. For all outcomes, we downgraded evidence because of study limitations (most studies had a high risk of performance bias, and we noted high risks of other bias in some stud-

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ies). We downgraded evidence due to indirectness, because some participants in studies may have had hospital-acquired infections before recruitment. We noted that one small study had a large influence on the effect for hospital-acquired infections, and we assessed decisions made in analysis of some cluster-randomised crossover studies on the effect for hospital-acquired infections and for mortality; we downgraded the evidence for these outcomes due to inconsistency. We also downgraded the evidence on length of stay in the ICU, because of imprecision. Data for adverse events were limited by few events and so we downgraded for imprecision.

Authorsâ&#x20AC;&#x2122; conclusions: Due to the very low-certainty evidence available, it is not clear whether bathing with chlorhexidine reduces hospital-acquired infections, mortality, or length of stay in the ICU, or whether the use of chlorhexidine results in more skin reactions.

Plain language summary Bathing critically ill patients with chlorhexidine to prevent hospital-acquired infections What is the aim of this review? The aim of this review was to find out whether people who are critically ill in hospital should be bathed with the antiseptic chlorhexidine, in order to prevent them from developing infections. Researchers from Cochrane collected and analysed all relevant studies to answer this question and found eight relevant randomised trials. Randomised trials are medical studies where people are chosen at random to receive different treatments. This study design provides the most reliable evidence on whether treatments have a relationship with desired or undesired health outcomes.

Key messages: This review assesses whether using chlorhexidine (instead of soap and water) to bathe patients in an intensive care unit (ICU), or a high-dependency or critical care unit reduces the number of hospital-acquired infections. The evidence available from the studies we analysed was very low quality, meaning that we cannot be certain whether bathing with chlorhexidine reduces the likelihood of critically-ill patients developing an infection, or dying. We are also uncertain whether bathing critically ill patients with chlorhexidine shortens the length of time people spend in hospital, or lowers their risk of developing skin reactions.

What was studied in the review? People who are critically ill (in an ICU, or a high-dependency or critical care unit) often catch infections during their time in hospital.

These infections can lead to longer hospital stays, additional medical complications, permanent disability or even death. Patients in ICUs are particularly vulnerable to infections because the bodyâ&#x20AC;&#x2122;s ability to fight infection is reduced by illness or trauma. Surgical tubes and lines (for example to help with feeding or breathing) may enable bacteria to enter the body. Chlorhexidine is a lowcost product which is used as an antiseptic and disinfectant in hospitals.

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What are the main results of the review? In December 2018 we searched for studies looking at the use of chlorhexidine for bathing critically ill patients. We found eight studies dating from 2005 to 2018, involving a total of 24,472 people across more than 20 ICUs. Seven studies included people who were adults, and one study included only children. All studies included both males and females. All studies compared bathing with chlorhexidine versus bathing with soap and water or nonantimicrobial washcloths. Four studies received funding from independent funders (government organisations, or from hospital or university departments) or reported no external funding, and four studies received funding from companies that manufactured chlorhexidine products.

The evidence from all eight studies combined is not sufficient to allow us to be certain whether patients bathed in chlorhexidine are less likely to catch an infection during their stay in the ICU. We are also uncertain whether patients bathed in chlorhexidine are less likely to die, because the certainty of the evidence from the six studies that reported on this is very low. We did not pool the evidence from the six studies that reported how long patients had stayed in the ICU, because the results differed widely. We are also uncertain whether patients bathed in chlorhexidine are likely to be in the ICU for less time, because the certainty of the evidence is very low. Reports from five studies provided different evidence about whether chlorhexidine led to more or less skin reactions; we are uncertain whether patients bathed in chlorhexidine are likely to have more or less skin reactions, because the certainty of the evidence is very low.

Quality of evidence: Most studies did not use methods to conceal the type of bathing solution that staff were using, which increases the risk that staff may have treated patients differently depending on whether patients were in the chlorhexidine study group or the soap-and-water study group. Participants in some studies may have already caught an infection before the start of the study and we were concerned that this might have affected our results. We also noticed wide differences in some results, and some outcomes had few reported events. These were reasons to judge the quality of the evidence to be very low.

How up to date is this review? We searched for studies that had been published up to December 2018.

Publication in The Cochrane Library Issue 9, 2019

Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery Michael Gallagher, Daniel J Jones, Sophie V Bell-Syer

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Citation example: Gallagher M, Jones DJ, Bell-Syer SV. Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery. Cochrane Database of Systematic Reviews 2019, Issue 9. Art. No.: CD005360.

DOI: 10.1002/14651858.CD005360.pub5.

ABSTRACT Background: Surgery has been used as part of breast cancer treatment for centuries; however any surgical procedure has the potential risk of infection. Infection rates for surgical treatment of breast cancer are documented at between 3% and 15%, higher than average for a clean surgical procedure. Pre- and perioperative antibiotics have been found to be useful in lowering infection rates in other surgical groups, yet there is no consensus on the use of prophylactic antibiotics for breast cancer surgery.

This is an update of a Cochrane Review first published in 2005 and last updated in 2014.

placebo or no antibiotic. Pooling of the results demonstrated that prophylactic antibiotics administered preoperatively probably reduce the incidence of SSI for patients undergoing breast cancer surgery without reconstruction (pooled risk ratio (RR) 0.67, 95% confidence interval (CI) 0.53 to 0.85; moderate certainty evidence).

Anticipated absolute effects were calculated for the outcome incidence of SSI; 105 per 1000 for the none or placebo group and 71 per 1000 (95% CI 56 to 89) for the preoperative antibiotic prophylaxis group. Analysis of the single study comparing perioperative antibiotic with no antibiotic was inconclusive for incidence of SSI (RR 0.11, 95% CI 0.01 to 1.95; very low certainty evidence).

No studies presented separate data for patients who underwent reconstructive surgery at the time of removal of the breast tumour.

Selection criteria: We included randomised controlled trials of pre- and perioperative antibiotics for patients undergoing surgery for breast cancer. Primary outcomes were rates of surgical site infection (SSI) and adverse reactions.

Secondary outcomes were not consistently included in the studies investigating preoperative antibiotic prophylaxis. It is very uncertain whether there is a difference in incidence of adverse events between the treatment and no treatment or placebo groups (10 studies, 2818 participants); very low certainty evidence downgraded one level for serious risk of bias, one level for serious inconsistency and one level for serious imprecision. It is unclear whether there is a difference in time to onset of infection between the treatment and no treatment or placebo groups (4 studies, 1450 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. It is unclear whether there is a difference in rates of readmission to hospital between the treatment and placebo groups (3 studies, 784 participants); low certainty evidence downgraded one level for serious inconsistency and one level for serious risk of bias. It is unclear whether there is a difference in cost of care between the treatment and no treatment or placebo groups (2 studies, 510 participants); low certainty evidence downgraded one level for serious risk of bias and one level for serious inconsistency. No analysable secondary outcome data were reported for the single study evaluating perioperative antibiotics.

Data collection and analysis: Three review authors independently examined the title and abstracts of all studies identified by the search strategy, then assessed study quality and extracted data from those that met the inclusion criteria. We contacted study authors to obtain missing information. We evaluated the certainty of evidence using the GRADE approach. We used standard methodological procedures expected by Cochrane.

Authors’ conclusions: Prophylactic antibiotics administered preoperatively probably reduce the risk of SSI in patients undergoing surgery for breast cancer. However, it is very uncertain whether there is an effect on incidence of adverse events. Furthermore, the effects on time to onset of infection, readmission to hospital and cost of care remain unclear. Further studies are required to establish the best protocols for clinical practice.

Main results: A total of 11 randomised controlled trials (2867 participants) were included in the review. No new studies were identified in this update. All studies included breast cancer patients and were based in the hospital setting. Ten studies evaluated preoperative antibiotic compared with no antibiotic or placebo. One study evaluated perioperative antibiotic compared with

Plain language summary

Objectives: To determine the effects of prophylactic (pre- or perioperative) antibiotics on the incidence of surgical site infection (SSI) after breast cancer surgery.

Search methods: For this fourth update, in August 2018 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Do antibiotics prevent surgical site infection after breast cancer surgery?

What was the aim of this review? The aim of this review was to determine whether giving people antibiot-

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ics before or during an operation is effective for preventing surgical site infection (SSI) following breast cancer surgery. Researchers from Cochrane collected and analysed all relevant studies (randomised controlled trials) to answer this question and found 11 relevant studies. Randomised controlled trials are medical studies where people are chosen at random to receive different treatments.

This type of trial provides the most reliable health evidence.

Key messages: There is moderate certainty evidence that antibiotics given before an operation probably reduce the risk of SSI in patients having surgery for breast cancer.

We cannot be certain whether antibiotics given during an operation reduce the risk of developing an SSI, as the available evidence is of very low certainty.

What was studied in this review? Breast cancer is the most common cancer affecting women and the leading cause of cancer death in women. Surgical removal of all or part of the breast is a common treatment for people diagnosed with breast cancer. However, an infection of the surgical wound is often a complication of the surgery, affecting up to 15% of patients. Having an SSI may require a longer stay in hospital or a repeat operation.

Taking antibiotics prior to the operation or during the operation aims to reduce the risk of developing an infection in the surgical wound.

What are the main results of the review? In August 2018 we searched for randomised controlled trials that investigated whether antibiotics given to people before or during surgery for breast cancer prevent an infection of the surgical site (SSI). This is an update of an existing review and no new relevant studies were found in the most recent search. We analysed the results of 11 studies with 2867 participants. Ten studies looked at giving antibiotics to patients prior to the surgery compared with not giving antibiotics or giving placebo. One study compared giving antibiotics perioperatively (between induction of anaesthetic and the patient leaving the recovery room) to not giving antibiotics. The results showed us that giving antibiotics before surgery probably reduced the risk of developing surgical site infection in patients undergoing breast cancer surgery with moderate certainty. No conclusions can be made from the results of the single study comparing perioperative antibiotics to no antibiotics as the evidence is of very low certainty. It is very uncertain whether there is an effect on incidence of adverse events. Furthermore, the effects on time to onset of infection, readmission to hospital and cost of care remain unclear. The review is not able to establish which antibiotic is most appropriate.

How up to date is this review? We searched for studies that had been published up to August 2018.

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Publication in The Cochrane Library Issue 12, 2019

Primary closure versus delayed or no closure for traumatic wounds due to mammalian bite Soumyadeep Bhaumik, Richard Kirubakaran, Sirshendu Chaudhuri Citation example: Bhaumik S, Kirubakaran R, Chaudhuri S. Primary closure versus delayed or no closure for traumatic wounds due to mammalian bite. Cochrane Database of Systematic Reviews 2019, Issue 12. Art. No.: CD011822. DOI: 10.1002/14651858.CD011822. pub2.

ABSTRACT Background: Mammalian bites are a common presentation in emergency and primary healthcare facilities across the world. The World Health Organization recommends postponing the suturing of a bite wound but this has not been evaluated through a systematic review.

Objectives: To assess the effects of primary closure compared with delayed closure or no closure for mammalian bite wounds.

Search methods: In July 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: We included randomised controlled trials which compared primary closure with delayed or no closure for traumatic wounds due to mammalian bite.

Data collection and analysis: Two review authors independently screened titles, abstracts and full-text publications, applied the inclusion criteria, and extracted data.

We pooled data using a random-effects model, as appropriate. We used the Cochrane â&#x20AC;&#x2DC;Risk of biasâ&#x20AC;&#x2122; tool and assessed the certainty of the evidence using the GRADE approach.

Main results: We found three trials (878 participants) that compared primary closure with no closure for dog bites and one trial (120 participants) that compared primary closure with delayed closure. No other mammalian bite studies were identified. The trials were from the UK (one trial), Greece (one trial) and China (two trials).

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Overall, participants from both sexes and all age groups were represented.

We are uncertain whether primary closure improves the proportion of wounds which are infection-free compared with no closure, as the certainty of evidence for this outcome was judged to be very low (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.97 to 1.05; 2 studies, 782 participants; I2 = 0%). We downgraded the evidence by one level for high risk of bias and two levels for imprecision. There is no clinically important difference in cosmesis (acceptable physical/cosmetic appearance) of dog bite wounds when primary closure is compared with no closure (mean difference (MD) -1.31, 95% CI -2.03 to -0.59; 1 study, 182 participants). The certainty of evidence for this outcome was judged to be moderate (we downgraded our assessment by one level for imprecision).

(randomised controlled trials). Randomised controlled trials are medical studies where people are chosen at random to receive different treatments. This type of trial provides the most reliable health evidence. We found four relevant studies.

Key messages: All the studies we found concerned dog bites. In terms of wound infection, we cannot be certain whether it is better to close dog bite wounds straight away, or wait a while before stitching, or leave them with no stitches. There was little difference in the appearance of the bite scar. Most of the evidence we found was of low certainty due to the size of the studies and the methods used.

We are uncertain whether primary closure improves the proportion of dog bite wounds that are infection-free compared with delayed closure, as the evidence for this outcome was judged to be very low (RR 0.98, 95% CI 0.90 to 1.07; 1 study, 120 participants; I2 = 0%). We downgraded the evidence by one level for high risk of bias and two levels for imprecision.

What was studied in the review? Mammalian bite wounds from animals such as dogs, cats and monkeys are a common problem throughout the world. In developed countries, many bite wounds are caused by domestic pets. In lower-income countries bites can also be caused by wild animals. Dogs are generally responsible for the majority of bites. Bite wounds are at high risk of infection as microbes are transmitted into the wound from the animal’s mouth. In lower-income countries these wound infections can lead to serious complications and in some cases death.

None of the four trials reported any adverse outcomes such as death or rabies but they were, in any case, unlikely to have been large enough to have satisfactory power to provide precise estimates for these. Important outcomes like time to complete wound healing, proportion of wounds healed, and length of hospital stay were not evaluated.

The first priorities when treating an animal bite are to stop the flow of blood from the wound, provide pain relief, and prevent infection. This can include appropriate vaccination against tetanus and rabies. It is often recommended that bite wounds are not stitched straight away if infection is suspected, as closing an infected wound could delay healing and be potentially fatal.

Authors’ conclusions: All the studies we identified concerned dog bites. There is no high-certainty evidence to support or refute existing recommendations concerning primary closure for dog bites. The potential benefits and harms of primary closure compared with delayed or no closure for mammalian bites remain uncertain and more robust trials are needed.

What are the main results of the review? In July 2019 we searched for randomised controlled trials comparing primary closure versus delayed or no closure for mammalian bite wounds. We found four relevant studies on dog bites. They were carried out in the UK, Greece and China. No other mammalian bite studies were identified.

Three of the studies we included compared primary closure with sutures (immediate stitches) with no closure for dog bite wounds. One study compared primary closure with delayed closure for dog bites. The people in the studies were followed, where stated, from 14 days to three months. Overall, participants from both sexes and all age groups were represented.

Plain language summary Primary closure (immediate stitches) versus delayed closure (delayed stitches) or no closure (no stitches) for traumatic wounds due to mammalian bite What is the aim of this review? The aim of this review was to find out whether animal bite wounds heal better when they are closed with stitches straight away (primary closure), or if the wounds are left open to heal for a short time before closure (delayed closure) or not stitched at all (no closure). We wanted to find out which wounds healed fastest, and if the method of closure affected the likelihood of wound infection, the appearance of the scar, the length of time patients were in hospital, and more serious side effects such as death. To answer this question, we collected and analysed all relevant studies

We are uncertain whether primary closure of dog bite wounds increases the proportion of wounds which are infection-free compared with no closure (very low-certainty evidence from two studies including a total of 782 people) and compared with delayed closure (very lowcertainty evidence from one study with a total of 120 people). There is little difference in the appearance of dog bite wounds when primary closure is compared with no closure (moderate-certainty evidence from one study with a total of 182 participants). None of the included

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Mohit Arora, Lisa A Harvey, Joanne V Glinsky, Lianne Nier, Lucija Lavrencic, Annette Kifley, Ian D Cameron

Data collection and analysis: Two review authors independently selected trials for inclusion, extracted data, and assessed risk of bias. We assessed the certainty of evidence using GRADE. Main results: We included 20 studies with 913 participants. The mean age of participants ranged from 26 to 83 years; 50% were male. ES was administered for a median (interquartile range (IQR)) duration of five (4 to 8) hours per week. The chronicity of the pressure ulcers was variable, ranging from a mean of four days to more than 12 months. Most of the pressure ulcers were on the sacral and coccygeal region (30%), and most were stage III (45%). Half the studies were at risk of performance and detection bias, and 25% were at risk of attrition and selective reporting bias. Overall, the GRADE assessment of the certainty of evidence for outcomes was moderate to very low. Nineteen studies were conducted in four different settings, including rehabilitation and geriatric hospitals, medical centres, a residential care centre, and a community-based centre.

Citation example: Arora M, Harvey LA, Glinsky JV, Nier L, Lavrencic L, Kifley A, Cameron ID. Electrical stimulation for treating pressure ulcers. Cochrane Database of Systematic Reviews 2020, Issue 1. Art. No.: CD012196. DOI: 10.1002/14651858.CD012196. pub2.

ES probably increases the proportion of pressure ulcers healed compared with no ES (risk ratio (RR) 1.99, 95% confidence interval (CI) 1.39 to 2.85; I2 = 0%; 11 studies, 501 participants (512 pressure ulcers)). We downgraded the evidence to moderate certainty due to risk of bias.

ABSTRACT Background: Pressure ulcers (also known as pressure sores, decubitus ulcers or bedsores) are localised injuries to the skin or underlying tissue, or both. Pressure ulcers are a disabling consequence of immobility. Electrical stimulation (ES) is widely used for the treatment of pressure ulcers. However, it is not clear whether ES is effective.

It is uncertain whether ES decreases pressure ulcer severity on a composite measure compared with no ES (mean difference (MD) -2.43, 95% CI -6.14 to 1.28; 1 study, 15 participants (15 pressure ulcers) and whether ES decreases the surface area of pressure ulcers when compared with no ES (12 studies; 494 participants (505 pressure ulcers)). Data for the surface area of pressure ulcers were not pooled because there was considerable statistical heterogeneity between studies (I2 = 96%) but the point estimates for the MD of each study ranged from -0.90 cm2 to 10.37 cm2. We downgraded the evidence to very low certainty due to risk of bias, inconsistency and imprecision.

studies reported proportion of wounds healed, the time to complete wound healing, length of hospital stay or adverse events. The number of people in the included studies was small, and the people who assessed the outcomes were aware of which treatment had been given.

Both of these are reasons why the results are uncertain.

How up to date is this review? We searched for studies that had been published up to July 2019.

Publication in The Cochrane Library Issue 1, 2020

Electrical stimulation for treating pressure ulcers

Objectives: To determine the effects (benefits and harms) of electrical stimulation (ES) for treating pressure ulcers.

Search methods: In July 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. We did not impose any restrictions with respect to language, date of publication or study setting.

Selection criteria: We included published and unpublished randomised controlled trials (RCTs) comparing ES (plus standard care) with sham/no ES (plus standard care) for treating pressure ulcers.

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It is uncertain whether ES decreases the time to complete healing of pressure ulcers compared with no ES (hazard ratio (HR) 1.06, 95% CI 0.47 to 2.41; I2 = 0%; 2 studies, 55 participants (55 pressure ulcers)). We downgraded the evidence to very low certainty due to risk of bias, indirectness and imprecision.

ES may be associated with an excess of, or difference in, adverse events (13 studies; 586 participants (602 pressure ulcers)). Data for adverse events were not pooled but the types of reported adverse events included skin redness, itchy skin, dizziness and delusions, deterioration of the pressure ulcer, limb amputation, and occasionally death. We downgraded the evidence to low certainty due to risk of selection and attrition bias and imprecision.

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ES probably increases the rate of pressure ulcer healing compared with no ES (MD 4.59% per week, 95% CI 3.49 to 5.69; I2 = 25%; 12 studies, 561 participants (613 pressure ulcers)). We downgraded the evidence to moderate certainty due to risk of bias. We did not find any studies that looked at quality of life, depression, or consumers’ perception of treatment effectiveness.

Authors’ conclusions: ES probably increases the proportion of pressure ulcers healed and the rate of pressure ulcer healing (moderate certainty evidence), but its effect on time to complete healing is uncertain compared with no ES (very low certainty evidence). It is also uncertain whether ES decreases the surface area of pressure ulcers.

The evidence to date is insufficient to support the widespread use of ES for pressure ulcers outside of research.

Future research needs to focus on large-scale trials to determine the effect of ES on all key outcomes.

Plain language summary Is electrical stimulation effective for treating pressure ulcers?

What is the aim of this review? The aim of this review was to find out whether electrical stimulation (ES; an electrical current applied to the skin) can help heal pressure ulcers. We collected and analysed all relevant studies (randomised controlled trials) to answer this question and found 20 relevant studies.

Key messages: ES compared with no ES probably increases the proportion of pressure ulcers healed and the rate of pressure ulcer healing (moderate certainty evidence) but its effect on time to complete healing and the surface area of pressure ulcers is uncertain (very low certainty evidence). The most commonly reported side effects of ES were reddening of the skin and discomfort.

There is a need for better quality research to determine whether ES is safe and effective.

What was studied in the review? Pressure ulcers (also known as pressure sores, bed sores or pressure injuries) are injuries to the skin and/or underlying tissue caused by sustained pressure over bony parts of the body such as the hips, heels or lower back. People with reduced mobility due to age, disability or illness are at risk of developing pressure ulcers.

ES is provided by an electrical current that can be applied to the skin in different ways. ES requires the placing of at least two small electrodes on the skin connected to a small battery-powered device which controls the intensity of the current. ES can be delivered either as a direct or pulsed current. It causes a tingling or vibratory sensation in most people except those who cannot feel due to conditions such as spinal cord injury. We reviewed the evidence about whether ES affects the number of pressure ulcers healed, the size and severity of the pressure ulcers, the time to complete healing, and

quality of life. We also wanted to find out about any side effects associated with ES. What are the main results of the review? This review includes the results of 20 randomised controlled trials dating from 1985 to 2018 and involving 913 participants. The average age of participants ranged from 26 to 83 years; 50% were male. Participants had their pressure ulcers for at least four days and in some cases for more than 12 months. The majority of pressure ulcers (60%) were serious and on or adjacent to the buttocks (62%).

Studies were conducted in four different settings, including rehabilitation and geriatric hospitals, medical centres, a residential care centre, and a community-based centre.

ES was administered for an average of five hours per week. Studies compared ES plus usual care (e.g. wound dressing, pressure relief, regular turning, nutritional advice and supplements) to no ES (but with usual care).

Eight studies out of 20 were funded by a device manufacturer with a vested interest in the results of the studies.

Eleven studies that compared ES with no ES indicated that ES probably improves the proportion of pressure ulcers healed (moderate certainty evidence based on 501 participants (512 pressure ulcers)). It is uncertain whether ES decreases pressure ulcer severity on a composite measure (based on 1 study with 15 participants (15 pressure ulcers)). The effect of ES on pressure ulcer area was not estimable because different studies showed very different results. It is uncertain whether ES decreases the surface area of pressure ulcers (very low certainty evidence based on 494 participants (505 pressure ulcers)). We cannot be certain whether ES has an effect on time to complete healing (very low certainty evidence based on 55 participants (55 pressure ulcers)). The common complications related to ES were skin redness and discomfort (low certainty evidence based on 586 participants (602 pressure ulcers)). Twelve studies also indicated that ES probably increases the rate of pressure ulcer healing (moderate certainty evidence based on 561 participants (613 pressure ulcers)). No studies reported results for quality of life or depression.

How up-to-date is this review? We searched for studies that had been published up to July 2019.

Publication in The Cochrane Library Issue 4, 2020

Subcuticular sutures for skin closure in non-obstetric surgery Saori Goto, Takashi Sakamoto, Riki Ganeko, Koya Hida, Toshi A Furukawa, Yoshiharu Sakai

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Citation example: Goto S, Sakamoto T, Ganeko R, Hida K, Furukawa TA, Sakai Y. Subcuticular sutures for skin closure in non-obstetric surgery. Cochrane Database of Systematic Reviews 2020, Issue 4. Art. No.: CD012124. DOI: 10.1002/14651858.CD012124. pub2.

Although the majority of studies enrolled people who underwent CDC class 1 (clean) surgeries, two-thirds of participants were enrolled in studies which included CDC class 2 to 4 surgeries, such as appendectomies and gastrointestinal surgeries. Most participants were adults in a hospital setting.

ABSTRACT Background: Following surgery, surgical wounds can be closed using a variety of devices including sutures (subcuticular or transdermal), staples and tissue adhesives.

Subcuticular sutures are intradermal stitches (placed immediately below the epidermal layer). The increased availability of synthetic absorbable filaments (stitches which are absorbed by the body and do not have to be removed) has led to an increased use of subcuticular sutures. However, in non-obstetric surgery, there is still controversy about whether subcuticular sutures increase the incidence of wound complications.

Subcuticular sutures versus transdermal sutures: There may be little difference in the incidence of SSI (risk ratio (RR) 1.10; 95% confidence interval (CI) 0.80 to 1.52; 3107 participants; low-certainty evidence).

Objectives: To examine the efficacy and acceptability of subcuticular sutures for skin closure in non-obstetric surgery.

Search methods: In March 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: All randomised controlled trials which compared subcuticular sutures with any other methods for skin closure in non-obstetric surgery were included in the review.

Data collection and analysis: Two review authors independently identified the trials, extracted data and carried out risk of bias and GRADE assessment of the certainty of the evidence.

Main results: We included 66 studies (7487 participants); 11 included trials had more than two arms. Most trials had poorly-reported methodology, meaning that it is unclear whether they were at high risk of bias. Most trials compared subcuticular sutures with transdermal sutures, skin staples or tissue adhesives. Most outcomes prespecified in the review protocol were reported. The certainty of evidence varied from high to very low in the comparisons of subcuticular sutures with transdermal sutures or staples and tissue adhesives; the certainty of the evidence for the comparison with surgical tapes and zippers was low to very low. Most evidence was downgraded for imprecision or risk of bias.

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It is uncertain whether subcuticular sutures reduce wound complications (RR 0.83; 95% CI 0.40 to 1.71; 1489 participants; very low-certainty evidence). Subcuticular sutures probably improve patient satisfaction (score from 1 to 10) (at 30 days; MD 1.60, 95% CI 1.32 to 1.88; 290 participants; moderate-certainty evidence).

Wound closure time is probably longer when subcuticular sutures are used (MD 5.81 minutes; 95% CI 5.13 to 6.49 minutes; 585 participants; moderate-certainty evidence).

Subcuticular sutures versus skin staples: There is moderate-certainty evidence that, when compared with skin staples, subcuticular sutures probably have little effect on SSI (RR 0.81, 95% CI 0.64 to 1.01; 4163 participants); but probably decrease the incidence of wound complications (RR 0.79, 95% CI 0.64 to 0.98; 2973 participants). Subcuticular sutures are associated with slightly higher patient satisfaction (score from 1 to 5) (MD 0.20, 95% CI 0.10 to 0.30; 1232 participants; high-certainty evidence). Wound closure time may also be longer compared with staples (MD 0.30 to 5.50 minutes; 1384 participants; low-certainty evidence).

Subcuticular sutures versus tissue adhesives, surgical tapes and zippers: There is moderate-certainty evidence showing no clear difference in the incidence of SSI between participants treated with subcuticular sutures and those treated with tissue adhesives (RR 0.77, 95% CI 0.41 to 1.45; 869 participants). There is also no clear difference in the incidence of wound complications (RR 0.62, 95% CI 0.35 to 1.11; 1058 participants; low-certainty evidence). Subcuticular sutures may also achieve lower patient satisfaction ratings (score from 1 to 10) (MD -2.05, 95% CI -3.05 to -1.05; 131 participants) (low-certainty evidence). In terms of SSI incidence, the evidence is uncertain when subcuticular sutures are compared with surgical tapes (RR 1.31, 95% CI 0.40 to 4.27; 354 participants; very low-certainty evidence) or surgical zippers (RR 0.80, 95% CI 0.08 to 8.48; 424 participants; very low-certainty evidence). There may be little difference in the incidence of wound complications between participants treated with subcuticular sutures and those treated with surgical tapes (RR 0.90, 95% CI 0.61 to 1.34; 492 participants; low-certainty evidence).

It is uncertain whether subcuticular sutures reduce the risk of wound complications compared with surgical zip-

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pers (RR 0.55, 95% CI 0.15 to 2.04; 424 participants; very low-certainty evidence). It is also uncertain whether it takes longer to close a wound with subcuticular sutures compared with tissue adhesives (MD -0.34 to 10.39 minutes; 895 participants), surgical tapes (MD 0.74 to 6.36 minutes; 169 participants) or zippers (MD 4.38 to 8.25 minutes; 424 participants) (very low-certainty evidence). No study reported results for patient satisfaction compared with surgical tapes or zippers.

What was studied in the review? Surgeons have various options for closing surgical wounds at the end of an operation. Skin closure can be carried out with stitches (sutures) that go under the skin, stitches that go over the skin, staples (clips), tissue adhesives (glue), tapes or other devices. Sutures can be absorbable (the stitches dissolve into the body as part of the healing process and do not need removing) or non-absorbable (the stitches need removing once the wound has healed).

Authorsâ&#x20AC;&#x2122; conclusions: There is no clear difference in the incidence of SSI for subcuticular sutures in comparison with any other skin closure methods. Subcuticular sutures probably reduce wound complications compared with staples, and probably improve patient satisfaction compared with transdermal sutures or staples. However, tissue adhesives may improve patient satisfaction compared with subcuticular sutures, and transdermal sutures and skin staples may be quicker to apply than subcuticular sutures. The quality of the evidence ranged from high to very low; evidence for almost all comparisons was subject to some limitations. There seems to be no need for additional new trials to explore the comparison with staples because there are high-quality studies with large sample sizes and some ongoing studies. However, there is a need for studies exploring the comparisons with transdermal sutures, tissue adhesives, tapes and zippers, with high-quality studies and large sample sizes, including long-term assessments.

Surgical site infections are a common problem after surgery and can cause a range of problems for patients. Surgical wounds can also cause unsightly scars if they do not heal correctly. We wanted to find out how stitches that go under the skin compare with other methods of closing surgical wounds in terms of infection, scarring, patient satisfaction, cost, pain, length of hospital stay and quality of life.

Plain language summary

The majority of studies compared stitches that go under the skin with standard stitches, skin staples or tissue adhesives.

Stitches that go under the skin for closing wounds after surgery What is the aim of this review? The aim of this review was to find out whether subcuticular sutures (stitches placed under the skin) are effective for closing wounds after surgery. We were interested in all types of surgery except obstetric surgery (operations related to childbirth, e.g. caesarean sections). Cochrane researchers collected and analysed all studies related to this question and found 66 relevant randomised controlled trials. Randomised controlled trials are medical studies where patients are chosen at random to receive different treatments. This type of trial provides the most reliable health evidence.

Key messages: In terms of wound infection following surgery, there is no clear difference between stitches that go under the skin and other methods of closing surgical wounds, such as standard stitches that go over the skin, surgical tape, staples, or glue. Stitches that go under the skin probably reduce wound complications compared with staples and improve patient satisfaction compared with stitches that go over the skin or staples. However, glue may improve patient satisfaction, and stitches that go over the skin and staples may be quicker for surgeons.

What are the main results of the review? In March 2019, we searched medical databases and identified 66 studies that compared stitches that go under the skin with other methods of skin closure such as standard stitches, skin staples, tissue adhesive, tape, or surgical zippers. Sixty-four of these studies (involving 7487 participants) were used in our analysis. On average, each study involved 115 people. Most participants were adults (20 to 75 years) undergoing surgery in a hospital setting.

Most studies did not state funding sources.

The main outcome of interest was whether wounds became infected. There was no clear difference between stitches that go under the skin and other closure methods in the number of people whose wounds became infected.

Compared with stitches that go over the skin, stitches that go under skin probably improve patient satisfaction.

There is evidence that stitches that go under the skin probably prevent wound complications and improve patient satisfaction compared with skin staples. Stitches that go under the skin may prevent wound breakdown (skin separation) compared with staples or tissue adhesives, but tissue adhesives may improve patient satisfaction. However, alternative methods may be quicker for surgeons to use than stitches that go under the skin.

There was no clear difference between stitches that go under the skin and the alternative closure methods for re-closure, pain, length of hospital stay and quality of life.

The studies we analysed often involved small numbers of participants and, in many cases, were not reported in a way that meant we could be sure they had been conducted robustly. We cannot, therefore, make conclusive

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statements about the effectiveness of stitches that go under the skin, and for all comparisons except the comparison with staples, better quality research is needed to form stronger conclusions.

Data collection and analysis: Three review authors independently performed study selection, ‘Risk of bias’ assessment, and data extraction. We assessed the certainty of the evidence using GRADE.

How up to date is this review? We searched for studies that had been published up to March 2019.

Main results: We identified five additional trials and one economic substudy in this update, resulting in the inclusion of a total of eight trials involving 3941 participants from acute and long-term care settings and two economic substudies in the review. Six studies reported the proportion of participants developing PI of any stage.

Two of the eight trials reported within-trial cost evaluations. Follow-up periods were short (24 hours to 21 days). All studies were at high risk of bias. Funding sources were reported in five trials.

Publication in The Cochrane Library Issue 6, 2020

Repositioning for pressure injury prevention in adults Brigid M Gillespie, Rachel M Walker, Sharon L Latimer, Lukman Thalib, Jennifer A Whitty, Elizabeth McInnes, Wendy P Chaboyer Citation example: Gillespie BM, Walker RM, Latimer SL, Thalib L, Whitty JA, McInnes E, Chaboyer WP. Repositioning for pressure injury prevention in adults.

Cochrane Database of Systematic Reviews 2020, Issue 6.

Art. No.: CD009958. DOI: 10.1002/14651858.

CD009958.pub3.

ABSTRACT Background: A pressure injury (PI), also referred to as a ‘pressure ulcer’, or ‘bedsore’, is an area of localised tissue damage caused by unrelieved pressure, friction, or shearing on any part of the body. Immobility is a major risk factor and manual repositioning a common prevention strategy. This is an update of a review first published in 2014.

Objectives: To assess the clinical and cost effectiveness of repositioning regimens(i.e. repositioning schedules and patient positions) on the prevention of PI in adults regardless of risk in any setting.

Search methods: We searched the Cochrane Wounds Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Ovid Embase, and EBSCO CINAHL Plus on 12 February 2019. We also searched clinical trials registries for ongoing and unpublished studies, and scanned the reference lists of included studies as well as reviews, meta-analyses, and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication, or study setting.

Selection criteria: Randomised controlled trials (RCTs), including cluster-randomised trials (c-RCTs), published or unpublished, that assessed the effects of any repositioning schedule or different patient positions and measured PI incidence in adults in any setting.

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Primary outcomes: proportion of new PI of any stage Repositioning frequencies: three trials compared different repositioning frequencies We pooled data from three trials (1074 participants) comparing 2-hourly with 4-hourly repositioning frequencies (fixed-effect; I² = 45%; pooled risk ratio (RR) 1.06, 95% confidence interval (CI) 0.80 to 1.41). It is uncertain whether 2-hourly repositioning compared with 4-hourly repositioning used in conjunction with any support surface increases or decreases the incidence of PI. The certainty of the evidence is very low due to high risk of bias, downgraded twice for risk of bias, and once for imprecision.

One of these trials had three arms (967 participants) comparing 2-hourly, 3-hourly, and 4-hourly repositioning regimens on high-density mattresses; data for one comparison was included in the pooled analysis. Another comparison was based on 2-hourly versus 3-hourly repositioning. The RR for PI incidence was 4.06 (95% CI 0.87 to 18.98). The third study comparison was based on 3-hourly versus 4-hourly repositioning (RR 0.20, 95% CI 0.04 to 0.92). The certainty of the evidence is low due to risk of bias and imprecision.

In one c-RCT, 262 participants in 32 ward clusters were randomised between 2-hourly and 3-hourly repositioning on standard mattresses and 4-hourly and 6-hourly repositioning on viscoelastic mattresses. The RR for PI with 2-hourly repositioning compared with 3-hourly repositioning on standard mattress is imprecise (RR 0.90, 95% CI 0.69 to 1.16; very low-certainty evidence).

The CI for PI include both a large reduction and no difference for the comparison of 4-hourly and 6-hourly repositioning on viscoelastic foam (RR 0.73, 95% CI 0.53 to 1.02). The certainty of the evidence is very low, downgraded twice due to high risk of bias, and once for imprecision.

Positioning regimens: four trials compared different tilt p ositions

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We pooled data from two trials (252 participants) that compared a 30° tilt with a 90° tilt (random-effects; I² = 69%). There was no clear difference in the incidence of stage 1 or 2 PI. The effect of tilt is uncertain because the certainty of evidence is very low (pooled RR 0.62, 95% CI 0.10 to 3.97), downgraded due to serious design limitations and very serious imprecision.

One trial involving 120 participants compared 30° tilt and 45° tilt with ‘usual care’ and reported no occurrence of PI events (low certainty evidence). Another trial involving 116 ICU patients compared prone with the usual supine positioning for PI. Reporting was incomplete and this is low certainty evidence.

Secondary outcomes: No studies reported health-related quality of life utility scores, procedural pain, or patient satisfaction.

Cost analysis: Two included trials also performed economic analyses.

A cost-minimisation analysis compared the costs of 3-hourly and 4-hourly repositioning with 2-hourly repositioning schedule amongst nursing home residents. The cost of repositioning was estimated at CAD 11.05 and CAD 16.74 less per resident per day for the 3-hourly or 4-hourly regimen, respectively, compared with the 2-hourly regimen. The estimates of economic benefit were driven mostly by the value of freed nursing time.

The analysis assumed that 2-, 3-, or 4-hourly repositioning is associated with a similar incidence of PI, as no difference in incidence was observed.

A second study compared the nursing time cost of 3-hourly repositioning using a 30° tilt with standard care (6-hourly repositioning with a 90° lateral rotation) amongst nursing home residents. The intervention was reported to be cost-saving compared with standard care (nursing time cost per patient EUR 206.60 versus EUR 253.10, incremental difference EUR −46.50, 95% CI EUR −1.25 to EUR −74.60).

Authors’ conclusions: Despite the addition of five trials, the results of this update are consistent with our earlier review, with the evidence judged to be of low or very low certainty. There remains a lack of robust evaluations of repositioning frequency and positioning for PI prevention and uncertainty about their effectiveness. Since all comparisons were underpowered, there is a high level of uncertainty in the evidence base.

Given the limited data from economic evaluations, it remains unclear whether repositioning every three hours using the 30° tilt versus “usual care” (90° tilt) or repositioning 3-to-4-hourly versus 2-hourly is less costly relative to nursing time.

Plain language summary Repositioning to prevent pressure injuries What was the aim of this review? The aim of this review was to compare different positions and repositioning frequencies to find out which were the most effective in preventing pressure injuries in adults regardless of risk or healthcare setting. We collected and analysed all relevant studies (i.e. randomised controlled trials, a type of study in which participants are assigned to one of two or more treatment groups using a random method, and which provides the most reliable health evidence) to answer this question and found eight relevant trials and two economic evaluations.

We found the effectiveness of repositioning frequencies to be unclear in the 2014 version of this review. This update includes the results of new trials conducted since that time.

Key messages: There is no clear evidence regarding which particular positions and repositioning frequencies are the most effective for preventing pressure injuries in adults. This is partly due to the low quality of the studies, most of which had small numbers of participants and were lacking in details about study methods. There is also limited evidence to support the cost-effectiveness of different repositioning frequencies and positions.

There is a need for further research to measure the effects of repositioning on pressure injury development and to find the best repositioning regimen relative to frequency and position.

What was studied in this review? Pressure injuries, also called pressure ulcers, pressure sores, decubitus ulcers, and bedsores, are caused by pressure and rubbing on the bony weight-bearing points of the body. A pressure injury is indicated by an area of localised damage to the skin or underlying tissue over a bony prominence. Pressure injuries occur most commonly in the elderly, or those who are immobile.

Repositioning is one strategy used alongside other strategies to prevent the development of pressure injuries.

Repositioning involves moving the person into a different position to redistribute pressure from a particular part of the body. We wanted to know which repositioning regimen was most effective in preventing pressure injuries in adults. We looked at the effect of different repositioning on peoples’ perceived satisfaction, pain, and quality of life. We were also interested in comparing the cost-effectiveness of different repositioning approaches.

What were the main results of this review? We identified eight clinical trials and two economic analyses published between 2004 and 2018 involving 3941 participants. Participant age ranged from 55 to 90 years. Three clinical trials compared repositioning frequencies using 

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2-, 3-, 4-, or 6-hourly repositioning. Three other trials compared different tilt positions.

logy reports. There were no restrictions on language, publication date or study setting.

Two included trials also included cost-effectiveness analyses. No studies reported health-related quality of life, procedural pain, or patient satisfaction.

Selection criteria: We included trials if they allocated participants to treatment randomly and compared NPWT with any other type of wound dressing, or compared one type of NPWT with another type of NPWT.

The evidence to support the use of one particular repositioning frequency and position over another to prevent pressure injuries is low in quality and limited in amount, therefore which position or frequency of repositioning is the most effective in reducing pressure injury development is unclear. None of the included trials reported on participant pain, satisfaction, or quality of life. Results were inconclusive, and the certainty of the evidence in the included trials is low to very low.

How up-to-date is this review? We searched for studies published up to February 2019.

Publication in The Cochrane Library Issue 6, 2020

Negative pressure wound therapy for surgical wounds healing by primary closure Gill Norman, En Lin Goh, Jo C Dumville, Chunhu Shi, Zhenmi Liu, Laura Chiverton, Monica Stankiewicz, Adam Reid Citation example: Norman G, Goh EL, Dumville JC, Shi C, Liu Z, Chiverton L, Stankiewicz M, Reid A. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database of Systematic Reviews 2020, Issue 6. Art. No.: CD009261. DOI: 10.1002/14651858.CD009261.pub6.

ABSTRACT Background: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). Existing evidence for the effectiveness of NPWT on postoperative wounds healing by primary closure remains uncertain.

Objectives: To assess the effects of NPWT for preventing SSI in wounds healing through primary closure, and to assess the cost-effectiveness of NPWT in wounds healing through primary closure.

Search methods: In June 2019, we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including In-Process & Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL Plus.

We also searched clinical trials registries and references of included studies, systematic reviews and health techno-

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Data collection and analysis: At least two review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, assessment using the Cochrane ‘Risk of bias’ tool, and quality assessment according to Grading of Recommendations, Assessment, Development and Evaluations methodology.

Main results: In this third update, we added 15 new randomised controlled trials (RCTs) and three new economic studies, resulting in a total of 44 RCTs (7447 included participants) and five economic studies. Studies evaluated NPWT in the context of a wide range of surgeries including orthopaedic, obstetric, vascular and general procedures. Economic studies assessed NPWT in orthopaedic, obstetric and general surgical settings. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain.

Primary outcomes: Four studies (2107 participants) reported mortality. There is low-certainty evidence (downgraded twice for imprecision) showing no clear difference in the risk of death after surgery for people treated with NPWT (2.3%) compared with standard dressings (2.7%) (risk ratio (RR) 0.86; 95% confidence interval (CI) 0.50 to 1.47; I2 = 0%). Thirty-nine studies reported SSI; 31 of these (6204 participants), were included in meta-analysis. There is moderate-certainty evidence (downgraded once for risk of bias) that NPWT probably results in fewer SSI (8.8% of participants) than treatment with standard dressings (13.0% of participants) after surgery; RR 0.66 (95% CI 0.55 to 0.80 ; I2 = 23%). Eighteen studies reported dehiscence; 14 of these (3809 participants) were included in meta-analysis.

There is low-certainty evidence (downgraded once for risk of bias and once for imprecision) showing no clear difference in the risk of dehiscence after surgery for NPWT (5.3% of participants) compared with standard dressings (6.2% of participants) (RR 0.88, 95% CI 0.69 to 1.13; I2 = 0%).

Secondary outcomes: There is low-certainty evidence showing no clear difference between NPWT and standard treatment for the outcomes of reoperation and incidence of seroma. For reoperation, the RR was 1.04 (95% CI 0.78 to 1.41; I2 = 13%; 12 trials; 3523 participants); for seroma, the RR was 0.72 (95% CI 0.50 to 1.05; I2 = 0%; seven trials; 729 participants). The effect of NPWT on occurrence of haematoma or skin blisters is uncertain (very low-certainty evidence); for haematoma, the RR

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was 0.67 (95% CI 0.28 to 1.59; I2 = 0%; nine trials; 1202 participants) and for blisters the RR was 2.64 (95% CI 0.65 to 10.68; I2 = 69%; seven trials; 796 participants). The overall effect of NPWT on pain is uncertain (very low-certainty evidence from seven trials (2218 participants) which reported disparate measures of pain); but moderate-certainty evidence suggests there is probably little difference between the groups in pain after three or six months following surgery for lower limb fracture (one trial, 1549 participants). There is also moderate-certainty evidence for women undergoing caesarean sections (one trial, 876 participants) and people having surgery for lower limb fractures (one trial, 1549 participants) that there is probably little difference in quality of life scores at 30 days or 3 or 6 months, respectively.

Cost-effectiveness: Five economic studies, based wholly or partially on trials included in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in four indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty and coronary artery bypass graft surgery. They calculated quality-adjusted life-years for treatment groups and produced estimates of the treatments’ relative cost-effectiveness. The reporting quality was good but the grade of the evidence varied from moderate to very low. There is moderate-certainty evidence that NPWT in surgery for lower limb fracture was not cost-effective at any threshold of willingness-topay and that NPWT is probably cost-effective in obese women undergoing caesarean section. Other studies found low or very low-certainty evidence indicating that NPWT may be cost-effective for the indications assessed.

Authors’ conclusions: People experiencing primary wound closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSI than people treated with standard dressings (moderate-certainty evidence). There is no clear difference in number of deaths or wound dehiscence between people treated with NPWT and standard dressings (low-certainty evidence). There are also no clear differences in secondary outcomes where all evidence was low or very low-certainty. In caesarean section in obese women and surgery for lower limb fracture, there is probably little difference in quality of life scores (moderate-certainty evidence). Most evidence on pain is very low-certainty, but there is probably no difference in pain between NPWT and standard dressings after surgery for lower limb fracture (moderate-certainty evidence).

Assessments of cost-effectiveness of NPWT produced differing results in different indications. There is a large number of ongoing studies, the results of which may change the findings of this review. Decisions about use of NPWT should take into account surgical indication and setting and consider evidence for all outcomes.

Plain language summary Negative pressure wound therapy for surgical wounds healing by primary closure What is the aim of this review? The aim of this Cochrane Review was to find out if negative pressure wound therapy (NPWT) has an effect on complications including infections in surgical wounds which are healing by primary closure (where the edges have been brought together, usually by using stitches or staples) and to assess its cost-effectiveness. We collected and analysed all relevant studies to answer this question and found 44 studies analysing NPWT and surgical site complications, and five studies analysing cost-effectiveness. This is a new update of a Cochrane review which was last updated in March 2019.

Key messages: NPWT probably reduces the incidence of surgical site infection (SSI) in surgical wounds healing by primary closure – this is moderate-certainty evidence and new studies could change this finding. It is not clear what effect NPWT has on reopening of the wound (“dehiscence”) and risk of death - this is low-certainty evidence. Results for other complications also show no clear difference with NPWT treatment. NPWT is probably cost-effective for caesarean section wounds in obese women and probably not cost-effective for fracture surgery wounds. Evidence for the cost-effectiveness of NPWT in other surgical wounds is less certain.

What was studied in the review? A potential complication of surgery is the development of SSI which can occur at the site of a surgical incision. The incidence of SSI can be as high as 40%, with an increased infection risk linked with age, diet, weight, diabetes, heart disease and cancer. An SSI can cause pain and discomfort, as well as increasing a person’s length of hospital stay and cost of treatment. Dehiscing (separation of wound edges) may occur if a wound fails to heal. Wound infection and weight can increase the risk of dehiscence.

NPWT is a sealed wound dressing attached to a vacuum pump which sucks fluid away from the wound. This may assist with wound healing and reduce risk of infection.

There has been a large number of new studies over the last decade as NPWT is increasingly being assessed for different surgical wound types. We assessed the effect of NPWT on risk of death, SSI and dehiscence.

What are the main results of the review? We found 44 studies analysing NPWT and surgical site complications and five studies analysing cost-effectiveness of NPWT. A total of 7447 participants have been included in the review. A wide variety of surgeries are included such as knee and hip operations, caesarean sections, operations for broken bones and abdominal surgeries. Most partici

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pants were enrolled in North America, Europe or Australasia.

ventions on the healing of foot ulcers in people with diabetes.

NPWT was compared with a standard dressing (e.g. gauze) in all 44 studies. A variety of NPWT systems was used. Only four studies reported risk of death; little difference was shown between NPWT and standard dressing and the evidence is low certainty. We pooled the SSI results of 31 studies; NPWT probably reduces the risk of SSI compared with standard dressings (moderate-certainty evidence). Fourteen studies which reported on dehiscence were combined; the low-certainty evidence suggests no clear difference between NPWT and standard care.

Search methods: In March 2020 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

In the cost-effectiveness analysis, two studies looked at women with caesarean sections, one looked at people with lower limb fractures, one at knee and hip surgeries, and one at heart surgery. All these studies used clinical information from studies included in this review. There is moderate-certainty evidence that NPWT is probably cost-effective for caesarean section wounds in obese women and probably not cost-effective for fracture surgery wounds. Evidence for the cost-effectiveness of NPWT in other surgical wounds is low or very low-certainty.

How up to date is this review? We searched for studies that had been published up to June 2019.

Publication in The Cochrane Library Issue 7, 2020

Nutritional interventions for treating foot ulcers in people with diabetes Zena EH Moore, Meave A Corcoran, Declan Patton Citation example: Moore ZEH, Corcoran MA, Patton D. Nutritional interventions for treating foot ulcers in people with diabetes. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No.: CD011378. DOI: 10.1002/14651858.CD011378.pub2.

ABSTRACT Background: Foot ulcers in people with diabetes are non-healing, or poorly healing, partial, or full-thickness wounds below the ankle. These ulcers are common, expensive to manage and cause significant morbidity and mortality. The presence of a wound has an impact on nutritional status because of the metabolic cost of repairing tissue damage, in addition to the nutrient losses via wound fluid. Nutritional interventions may improve wound healing of foot ulcers in people with diabetes.

Objectives: To evaluate the effects of nutritional inter-

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Selection criteria: We included randomised controlled trials (RCTs) that evaluated the effect of nutritional interventions on the healing of foot ulcers in people with diabetes.

Data collection and analysis: Two review authors, working independently, assessed included RCTs for their risk of bias and rated the certainty of evidence using GRADE methodology, using pre-determined inclusion and quality criteria.

Main results: We identified nine RCTs (629 participants). Studies explored oral nutritional interventions as follows: a protein (20 g protein per 200 mL bottle), 1 kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and b-hydroxy-b-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D, versus 300,000 IU of vitamin D; 250 mg magnesium oxide plus 400 IU vitamin E and 50,000 IU vitamin D supplements. The comparator in eight studies was placebo, and in one study a different dose of vitamin D. Eight studies reported the primary outcome measure of ulcer healing; only two studies reported a measure of complete healing. Six further studies reported measures of change in ulcer dimension, these studies reported only individual parameters of ulcer dimensions (i.e. length, width and depth) and not change in ulcer volume.

All of the evidence identified was very low certainty. We downgraded it for risks of bias, indirectness and imprecision.

It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, increases the proportion of ulcers healed at six months more than placebo (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53). It is also uncertain whether arginine, glutamine and b-hydroxy-bmethylbutyrate supplement increases the proportion of

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ulcers healed at 16 weeks compared with placebo (RR 1.09, 95% CI 0.85 to 1.40).

It is uncertain whether the following interventions change parameters of ulcer dimensions over time when compared with placebo; 220 mg zinc sulphate supplement containing 50 mg elemental zinc, 250 mg magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation. It is also uncertain whether 150,000 IU of vitamin D, impacts ulcer dimensions when compared with 300,000 IU of vitamin D. Two studies explored some of the secondary outcomes of interest for this review. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, reduces the number of deaths (RR 0.96, 95% CI 0.06 to 14.60) or amputations (RR 4.82, 95% CI 0.24 to 95.88) more than placebo. It is uncertain whether arginine, glutamine and b-hydroxyb-methylbutyrate supplement increases health-related quality of life at 16 weeks more than placebo (MD −0.03, 95% CI −0.09 to 0.03). It is also uncertain whether arginine, glutamine and b-hydroxy-b-methylbutyrate supplement reduces the numbers of new ulcers (RR 1.04, 95% CI 0.71 to 1.51), or amputations (RR 0.66, 95% CI 0.16 to 2.69) more than placebo.

None of the included studies reported the secondary outcomes cost of intervention, acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence.

One study exploring the impact of arginine, glutamine and b-hydroxy-b-methylbutyrate supplement versus placebo did not report on any relevant outcomes.

Authors’ conclusions: Evidence for the impact of nutritional interventions on the healing of foot ulcers in people with diabetes compared with no nutritional supplementation, or compared with a different dose of nutritional supplementation, remains uncertain, with eight studies showing no clear benefit or harm. It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo. More research is needed to clarify the impact of nutritional interventions on the healing of foot ulcers in people with diabetes.

Plain language summary Dietary supplements for treating foot ulcers in people with diabetes

What is the aim of this review? We wanted to find out whether nutritional supplements or special diets are effective in treating foot ulcers in people with diabetes.

Researchers from Cochrane collected and analysed all relevant studies (randomised controlled trials (RCTs)) to answer this question and found nine studies for inclusion. RCTs are medical studies where the treatment or care people receive is are chosen at random. This type of trial provides the most reliable health evidence about whether different approaches to treatment or care make a difference.

Key messages: Of the nine studies that we identified, eight reported the outcomes we were interested in, primarily impact on ulcer healing. Findings from five studies showed very low-certainty evidence regarding the effect of oral nutritional supplements in tablet form on the healing of foot ulcers in people with diabetes. These five studies did not measure healing in such a way that we could be certain of the results, and they did not have enough participants for us to be certain of the effects.

The results of three other studies also showed very lowcertainty evidence as to whether nutritional supplements in other forms have any impact on ulcer healing. Two of these studies showed very low-certainty evidence as to whether nutritional supplement drinks have any impact on other outcomes such as death, likelihood of amputation, reduction in numbers of new ulcers, or people’s quality of life. These studies were not well conducted and did not have enough participants involved for us to be certain of the effects.

What was studied in the review? People with diabetes can develop foot ulcers. These are often due to reduced blood supply, reduced sensation, foot deformity, the presence of trauma, or a combination of all or some of these causes. Foot ulcers are a serious complication of diabetes and can result in serious consequences such as amputation.

It is thought that foot ulcers, like other wounds, heal better, and more quickly, if people are well-nourished.

Food supplements containing certain vitamins and protein can be given to people with foot ulcers and diabetes to help to treat their wounds.

What are the main results of the review? We found nine relevant studies dating from 2004 to 2019, involving 629 participants, 72% were men, aged, on average, 59.2 years. Most studies took place in hospital outpatient clinics. Three studies explored a different nutritional supplement drink and compared this with a drink that looked the same but did not have any added nutritional supplement. Five studies explored the effects of different types of nutritional tablets and compared these with tablets that did not contain any active ingredient, or nutritional supplement. One study compared two different doses of a vitamin D injection. One study did not report any of the outcomes of interest for this review.

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Two of the studies were sponsored by the manufacturers of the nutritional supplement, five studies were sponsored by Iranian university research funding.

Findings from eight studies are unclear as to whether nutritional interventions improve the healing of foot ulcers in people with diabetes compared with no nutritional supplementation, or compared with a different dose of nutritional supplementation. One study reported adverse events and two studies reported numbers of amputations. Results are unclear as to whether there is a difference in the numbers of amputations or deaths between nutritional supplementation and no nutritional supplementation. It is also unclear if there is a difference in health-related quality of life or number of ulcers that recur between nutritional supplementation and no nutritional supplementation.

Overall, we judged the certainty of the evidence to be very low. None of the studies had enough participants, five did not measure outcomes in such a way that we could be certain of the results and the studies were not well conducted, so we are not very confident in the results. Additional studies at low risk of bias and of highcertainty evidence are needed to clarify the role of nutritional interventions for the treatment of foot ulcers in people with diabetes.

How up to date is this review? We searched for studies that had been published up to March 2020.

Publication in The Cochrane Library Issue 7, 2020

Topical treatment for facial burns Cornelis J Hoogewerf, M Jenda Hop, Marianne K Nieuwenhuis, Irma MMH Oen, Esther Middelkoop, Margriet E Van Baar Citation example: Hoogewerf CJ, Hop MJ, Nieuwenhuis MK, Oen IMMH, Middelkoop E, Van Baar ME. Topical treatment for facial burns. Cochrane Database of Systematic Reviews 2020, Issue 7. Art. No.: CD008058.

DOI: 10.1002/14651858.CD008058.pub3.

ABSTRACT Background: Burn injuries are an important health problem. They occur frequently in the head and neck region. The face is the area central to a personâ&#x20AC;&#x2122;s identity that provides our most expressive means of communication. Topical interventions are currently the cornerstone of treatment of burns to the face.

Objectives: To assess the effects of topical interventions on wound healing in people with facial burns of any depth.

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Search methods: In December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: Randomised controlled trials (RCTs) that evaluated the effects of topical treatment for facial burns were eligible for inclusion in this review.

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

Main results: In this first update, we included 12 RCTs, comprising 507 participants.

Most trials included adults admitted to specialised burn centres after recent burn injuries.

Topical agents included antimicrobial agents (silver sulphadiazine (SSD), Aquacel-Ag, cerium-sulphadiazine, gentamicin cream, mafenide acetate cream, bacitracin), non-antimicrobial agents (Moist Exposed Burn Ointment (MEBO), saline-soaked dressings, skin substitutes (including bioengineered skin substitute (TransCyte), allograft, and xenograft (porcine Xenoderm), and miscellaneous treatments (growth hormone therapy, recombinant human granulocyte-macrophage colony-stimulating factor hydrogel (rhGMCS)), enzymatic debridement, and cream with Helix Aspersa extract).

Almost all the evidence included in this review was assessed as low or very low-certainty, often because of high risk of bias due to unclear randomisation procedures (i.e. sequence generation and allocation concealment); lack of blinding of participants, providers and sometimes outcome assessors; and imprecision resulting from few participants, low event rates or both, often in single studies.

Topical antimicrobial agents versus topical non-antimicrobial agents: There is moderate-certainty evidence that there is probably little or no difference between antimicrobial agents and non-antimicrobial agents (SSD and MEBO) in time to complete wound healing (hazard ratio (HR) 0.84 (95% confidence interval (CI) 0.78 to 1.85, 1 study, 39 participants). Topical antimicrobial agents may make little or no difference to the proportion of wounds completely healed compared with topical non-antimicrobial agents (comparison SSD and MEBO, risk ratio (RR) 0.94, 95% CI 0.68 to 1.29; 1 study, 39

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participants; low-certainty evidence). We are uncertain whether there is a difference in wound infection (comparison topical antimicrobial agent (Aquacel-Ag) and MEBO; RR 0.38, 95% CI 0.12 to 1.21; 1 study, 40 participants; very low-certainty evidence). No trials reported change in wound surface area over time or partial wound healing. There is low-certainty evidence for the secondary outcomes scar quality and patient satisfaction. Two studies assessed pain but it was incompletely reported.

Topical antimicrobial agents versus other topical antimicrobial agents: It is uncertain whether topical antimicrobial agents make any difference in effects as the evidence is low to very low-certainty. For primary outcomes, there is low-certainty evidence for time to partial (i.e. greater than 90%) wound healing (comparison SSD versus cerium SSD: mean difference (MD) –7.10 days, 95% CI –16.43 to 2.23; 1 study, 142 participants).

There is very low-certainty evidence regarding whether topical antimicrobial agents make a difference to wound infection (RR 0.73, 95% CI 0.46 to 1.17; 1 study, 15 participants). There is low to very low-certainty evidence for the proportion of facial burns requiring surgery, pain, scar quality, adverse effects and length of hospital stay.

Skin substitutes versus topical antimicrobial agents: There is low-certainty evidence that a skin substitute may slightly reduce time to partial (i.e. greater than 90%) wound healing, compared with a non-specified antibacterial agent (MD –6.00 days, 95% CI –8.69 to –3.31; 1 study, 34 participants).

We are uncertain whether skin substitutes in general make any other difference in effects as the evidence is very low certainty. Outcomes included wound infection, pain, scar quality, adverse effects of treatment and length of hospital stay.

Single studies showed contrasting low-certainty evidence.

A bioengineered skin substitute may slightly reduce procedural pain (MD –4.00, 95% CI –5.05 to –2.95; 34 participants) and background pain (MD –2.00, 95% CI –3.05 to –0.95; 34 participants) compared with an unspecified antimicrobial agent. In contrast, a biological dressing (porcine Xenoderm) might slightly increase pain in superficial burns (MD 1.20, 95% CI 0.65 to 1.75; 15 participants (30 wounds)) as well as deep partial thickness burns (MD 3.00, 95% CI 2.34 to 3.66; 10 participants (20 wounds)), compared with antimicrobial agents (Physiotulle Ag (Coloplast)).

Miscellaneous treatments versus miscellaneous treatments: Single studies show low to very low-certainty effects of interventions. Low-certainty evidence shows that MEBO may slightly reduce time to complete wound healing compared with saline soaked dressing (MD –1.7 days, 95% CI –3.32 to –0.08; 40 participants). In addition, a cream containing Helix Aspersa may slightly increase the proportion of wounds com-

pletely healed at 14 days compared with MEBO (RR 4.77, 95% CI 1.87 to 12.15; 43 participants). We are uncertain whether any miscellaneous treatment in the included studies makes a difference in effects for the outcomes wound infection, scar quality, pain and patient satisfaction as the evidence is low to very low-certainty.

Authors’ conclusions: There is mainly low to very lowcertainty evidence on the effects of any topical intervention on wound healing in people with facial burns. The number of RCTs in burn care is growing, but the body of evidence is still hampered due to an insufficient number of studies that follow appropriate evidence-based standards of conducting and reporting RCTs.

Plain language summary Topical treatment for facial burns Review question: We reviewed the evidence about the effects of topical (applied to the surface of the skin) treatments for healing burn wounds on the face or neck. We wanted to find out which treatments were most effective at healing these wounds and improving the appearance of scars, which is a particularly important issue in relation to facial burn injuries. We also wanted to find out how topical treatments affected the risk of complications such as infection and pain, and how they impacted on peoples’ quality of life.

Background: Burn injuries are an important health problem, and a major global cause of disability and disfigurement in both adults and children. Women and children in low-income countries are at particular risk.

Burns pose particular problems when they occur on the head or neck. The face is central to a person’s identity and plays a vital role in communication. Other basic functions such as hearing, smell and breathing may become affected as a direct result of a facial burn. Topical treatments such as (non) antimicrobial creams and skin substitutes, are most commonly used to treat facial burns. We wanted to compare the effectiveness of these treatments to evaluate their benefits and harms.

Study characteristics: In December 2019, we searched for randomised controlled trials (RCTs) investigating topical treatments for facial burns. RCTs are medical studies where the treatment or care people receive is chosen at random. This type of study design provides the most reliable health evidence about whether different approaches to treatment or care can make a difference.

We found 12 studies that were suitable for inclusion in this review update, with 507 participants with mean ages ranging from 5.3 to 41.9 years. Three studies compared antimicrobials with non-antimicrobials agents, two studies compared different antimicrobials, four studies compared skin substitutes with antimicrobials, while four studies compared a variety of topical treatments. One study contributed to two comparisons. Eight studies

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were small (fewer than 40 participants) and almost all studies were at high risk of bias due to lack of blinding (where participants and evaluators may have known which group the participants were allocated to and interpreted effects differently).

Key results: Overall, there is mainly low to very low-certainty evidence on the effects of any topical intervention on wound healing or infection in people with facial burns. In addition, there is low to very low-certainty evidence on the effects of the included interventions on need for surgery, pain, scar quality, patient satisfaction, length of hospital stay and side effects.

All results were at high risk of bias and varied, which may have exaggerated the effects.

Certainty of the evidence: Overall, the certainty of the evidence about the effectiveness of topical treatments for facial burns is low to very low. There is insufficient reliable evidence as to whether topical treatments improve outcomes for people with facial burns including improving wound healing, or rates of infection. Better trial design and reporting of these studies is required to contribute to evidence-based burn care.

How up to date is this review? We searched for studies that had been published up to December 2019.

Publication in The Cochrane Library Issue 9, 2020

Hydrosurgical debridement versus conventional surgical debridement for acute partial-thickness burns Justin CR Wormald, Ryckie G Wade, Jonathan A Dunne, Declan P Collins, Abhilash Jain Citation example: Wormald JCR, Wade RG, Dunne JA, Collins DP, Jain A. Hydrosurgical debridement versus conventional surgical debridement for acute partialthickness burns. Cochrane Database of Systematic Reviews 2020, Issue 9. Art. No.: CD012826.DOI: 10.1002/14651858.CD012826.pub2.

ABSTRACT Background: Burn injuries are the fourth most common traumatic injury, causing an estimated 180,000 deaths annually worldwide. Superficial burns can be managed with dressings alone, but deeper burns or those that fail to heal promptly are usually treated surgically. Acute burns surgery aims to debride burnt skin until healthy tissue is reached, at which point skin grafts or temporising dressings are applied. Conventional debridement is performed with an angled blade, tangentially shaving

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burned tissue until healthy tissue is encountered. Hydrosurgery, an alternative to conventional blade debridement, simultaneously debrides, irrigates, and removes tissue with the aim of minimising damage to uninjured tissue. Despite the increasing use of hydrosurgery, its efficacy and the risk of adverse events following surgery for burns is unclear.

Objectives: To assess the effects of hydrosurgical debridement and skin grafting versus conventional surgical debridement and skin grafting for the treatment of acute partial-thickness burns.

Search methods: In December 2019 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE (including 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 and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.

Selection criteria: We included randomised controlled trials (RCTs) that enrolled people of any age with acute partial-thickness burn injury and assessed the use of hydrosurgery.

Data collection and analysis: Two review authors independently performed study selection, data extraction, ‘Risk of bias’ assessment, and GRADE assessment of the certainty of the evidence.

Main results: One RCT met the inclusion criteria of this review. The study sample size was 61 paediatric participants with acute partial-thickness burns of 3% to 4% total burn surface area. Participants were randomised to hydrosurgery or conventional debridement. There may be little or no difference in mean time to complete healing (mean difference (MD) 0.00 days, 95% confidence interval (CI) −6.25 to 6.25) or postoperative infection risk (risk ratio 1.33, 95% CI 0.57 to 3.11). These results are based on very low-certainty evidence, which was downgraded twice for risk of bias, once for indirectness, and once for imprecision.

There may be little or no difference in operative time between hydrosurgery and conventional debridement (MD 0.2 minutes, 95% CI −12.2 to 12.6); again, the certainty of the evidence is very low, downgraded once for risk of bias, once for indirectness, and once for imprecision. There may be little or no difference in scar outcomes at six months. Health-related quality of life, resource use, and other adverse outcomes were not reported.

Authors’ conclusions: This review contains one randomised trial of hydrosurgery versus conventional

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debridement in a paediatric population with low percentage of total body surface area burn injuries. Based on the available trial data, there may be little or no difference between hydrosurgery and conventional debridement in terms of time to complete healing, postoperative infection, operative time, and scar outcomes at six months. These results are based on very low-certainty evidence. Further research evaluating these outcomes as well as health-related quality of life, resource use, and other adverse event outcomes is required.

Plain language summary Is surgery with a high-pressure water jet (hydrosurgery) better than conventional surgery for early treatment of mid-depth burns?

Background: Burns are common injuries worldwide and can cause illness, lifelong disability and even death. Deep burns often require surgery because the skin is too damaged to heal on its own. The damaged, burnt skin must therefore be cut away (debridement) and replaced with healthy skin, which is typically a very thin layer of healthy skin (graft) taken from another part of the body.

Debridement is normally done with a specific surgical knife.

Recently, a high-pressure, water-based jet system has been developed, known as hydrosurgery. This tool removes burnt skin only, leaving behind the unburned, healthy skin. Hydrosurgery may be more accurate than a knife in terms of removing burned skin, which may lead to better healing.

All open wounds, including burns, are at risk of infection so adequate debridement is important to reduce the risk of infection. If the wound is closed quickly, it will heal better, with less scarring and less risk of infection.

What did we want to find out? In this Cochrane Review, we wanted to know whether burns treated with hydrosurgery heal more quickly and with fewer infections than burns treated with a knife. We also wanted to see whether there were any differences in overall quality of life, how well the wound healed in terms of scarring

and the amount of medical resources used (using measures like the number of dressing changes and burn clinic appointments, length of hospital stay, and whether further surgery was needed).

Our methods: We searched medical databases for randomised controlled trials that compared burn treatment using hydrosurgery with conventional debridement.

Randomised controlled trials are medical studies where the treatment people receive is chosen at random. This type of study provides the most reliable evidence about whether different approaches to health care make a difference. Participants in the studies could be any age. The studies could have taken place anywhere and be reported in any language.

What are the main results of the review? We found only one Australian study that included 61 children with small burns. The children were randomly allocated to treatment with either hydrosurgery or conventional debridement. Hydrosurgery made little or no difference in the time burns took to heal completely, infection after the operation, or scarring compared to conventional debridement. There was little or no difference in the length of time debridement took using hydrosurgery compared with conventional surgery. The study did not give any information about quality of life or resource use.

Certainty of the evidence: Our certainty (confidence) in the evidence was very limited because we found only one study. It only included children, so the results may not apply to adults or people with more severe burns. It was a randomised study, but did not report the outcomes we expected it to, so we are not sure how reliable its results are.

Conclusions: We do not know if hydrosurgery is better than conventional surgery for early treatment of middepth burns. We need more studies to investigate this question.

Search date: This review includes evidence published up to December 2019.

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

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

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JOURNAL OF EWMA - PREVIOUS ISSUES

Volume 20, no 2, October 2019 A systematic review: Topical treatment for controlling malignant wound odour Winardi A, Irwan A M Psychological factors associated with malignant fungating breast wounds Robinson P J, Holloway S L Effects of radiotherapy on wounds healing Robinson P J, Holloway S L Wounds Research Network (WReN) – a community of practice for improving wound care-related trials Samuriwo R

Volume 20, no 1, April 2019 O F T H E E U R O P E A N W O U N D M A N A G E M E N T A S S O C I AT I O N

Volume 20 · Number 1 · May 2019

Patient-centred wound care

Finnish Nurses’ Perception of Client-centred Wound Care Seppänen S Optimising Wellbeing in Patients with Diabetic Foot Ulcers McIntosh C, Ivory J D, Gethin G, MacGilchrist C Taking Care of an Individual’s Needs at Home: Experiences of a Community Care Nursing Group Ghilardi S, Noris M, Negroni A, Paggi B, Giunni L Post-surgical Pyoderma Gangrenosum: A Retrospective Analysis of four Clinical Cases Isoherranen K A Case Report: Toxic Edipermal Necrolysis in Children Ferreira J, Santos M, Souza M, Silva G, Monteiro A, Yogui H, Santana I Factors that create Obstacles and Opportunity for Patient Participation in Orthopaedic Nursing Care Stålenhag S, Sterner E

Volume 19, no 2, October 2018 The future of pressure ulcer prevention is here: Detecting and targeting inflammation early Gefen A Need for an international consensus conference on heel pressure injuries: A preliminary literature review Rivolo M, Marcadelli S Using technology to advance pressure ulcer risk assessment and self-care: Challenges and potential benefits Patton D, Moore Z, O’Connor T, Shanley E, De Oliveira A L, Vitoriano A, Walsh S G, Nugent L E Prevalence of pressure injuries and other dependence-related skin lesions among paediatric patients in hospitals in Spain Pancorbo-Hidalgo P L, Torra-Bou J E, Garcia-Fernandez F P, Soldevilla-Agreda J J Survey of wound prevalence in a long-term care facility Peckford S

Volume 19, no 1, April 2018 Opinions that matter: Patient’s perspective of their perioperative management during surgery for diabetic foot Piaggesi A, Bonaventura L, Giusti S, Goretti C, Menichini C Skin tears in the aging population: Remember the 5 Ws Vanzi V, LeBlanc K Recommendations to improve health care for people with chronic diseases Maggini M, Zaletel J Bioburden levels of spools of surgical tape in different healthcare settings Yu V, Deing V, Nehrdich T, Struensee B Specific risk factors for pressure ulcer development in adult critical care patients – a retrospective cohort study Ahtiala M, Soppi E, Tallgren M Prevalence of chronic wound in different modalities of care in Germany Kröger K, Jöster M

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