BACKGROUND:Strong compression is a recommended first line venous leg ulcer treatment. With limited research comparing the clinical effectiveness of compression wraps (CW) and two-layer compression bandage treatments with evidence-based compression (EBC) (four-layer compression bandages and two-layer compression hosiery), this study aimed to evaluate their clinical effectiveness on time to venous leg ulcer healing. METHODS AND FINDINGS:A pragmatic, three-arm, randomised controlled trial in 33 United Kingdom primary, community and hospital sites between 03.02.2021 and 31.08.2024. Adults with a venous leg ulcer appropriate for compression therapy were randomised 1:1:1 to be offered CW, two-layer bandage, or EBC (two-layer hosiery or four-layer bandage). Participants and clinical staff were not blinded. The primary outcome was time to blind assessed ulcer healing (date of ulcer healing: date of earliest photograph showing healing). Analyses included a noninferiority comparison of two-layer bandage and EBC (handling key intercurrent events under hypothetical and treatment policy strategies), and superiority comparisons of CW with both EBC and two-layer bandage (handling key intercurrent events under a treatment policy strategy). Healing times were analysed using Cox proportional hazards regression adjusted for fixed effects (treatment allocation, baseline ulcer area and duration, participant age, and mobility status), and shared frailties (recruitment site). The trial was pre-registered: ISRCTN67321719. 637 participants were randomised to be offered CW (n = 213), two-layer bandage (n = 211) or EBC (n = 213). Mean age was 70.3 (range 24.6 to 97.0) years, 55% (n = 351) were male, and the majority (n = 606, 95%) were white. 633 participants contributed time at risk of healing and were included in the analysis. Using a treatment policy strategy to handle key intercurrent events (modified intention-to-treat analysis), the estimated hazard ratio (HR) for the noninferiority comparison (EBC and two-layer bandage) was 1.01 (95% CI [0.79, 1.28]), meeting the pre-specified noninferiority margin of 1.33. The corresponding hypothetical strategy analysis gave a HR of 1.16 (95% CI [0.86, 1.58]), which did not demonstrate noninferiority. For the superiority comparisons, healing was slower in the CW group than in the EBC group (HR 0.78, 95% CI [0.61, 1.00]; p = 0.046). Results were similar for the two-layer bandage group (HR 0.79, 95% CI [0.61, 1.01]; p = 0.056), although this did not reach statistical significance. Both comparisons showed considerable statistical uncertainty, with confidence intervals ranging from a 39% reduction in the hazard of healing to little or no difference between groups. Nine serious adverse events occurred; one potentially related to treatment (cause of death could not be ascertained). Departures from allocated compression treatment were common, which limits generalisability to settings with different adherence patterns. These departures, lower than expected ulcer healing incidence rates and slight under-recruitment, resulted in the number of healing events being smaller than the number required for 80% power. CONCLUSION:CW is unlikely to reduce the time to venous leg ulcer healing compared to two-layer bandage or EBC, although confidence intervals included treatment effects indicating little or no difference between groups. Despite remaining uncertainty, these findings may not support CW as a first line strong compression treatment for venous leg ulcers. TRIAL REGISTRATION:ISRCTN - reference 67321719.

BACKGROUND:A venous leg ulcer is a chronic leg wound caused by poor venous blood circulation in the lower limbs. It is a recurring condition causing pain, malodour, reduced mobility, and depression. Randomised controlled trials evaluating treatments for venous leg ulcers provide important evidence to inform clinical decision-making. However, for findings to be useful, outcomes need to be clinically meaningful, consistently reported across trials, and fully reported. Research has identified the large number of outcomes reported in venous leg ulcer trials, impacting both synthesis of results, and clinical decision-making. To address this, a core outcome set will be developed. A core outcome set is an agreed standardised set of outcomes which should be, as a minimum, measured and reported in all trials which evaluate treatment effectiveness for a given indication. A core outcome set has the potential to reduce research waste, improve the utility of RCTs, reduce reporting bias, facilitate treatment comparisons across different sources of evidence and expedite the production of systematic reviews, meta-analyses and evidence-based clinical guidelines. AIM:The aim of this project is to develop a core outcome set for research evaluating the effectiveness of interventions for treating venous leg ulceration. METHODS:Through a scoping review of the literature on venous leg ulceration, we will firstly identify a list of candidate outcome domains (broad categories in relation to what is being measured) from randomised controlled trials and qualitative research, and outcomes (specific methods in relation to what is being measured). In two further stages, we will use the resulting lists of outcome domains and outcomes to design two online surveys. A range of stakeholders will be invited to participate in the surveys and they will be asked to indicate which outcome domains and outcomes are most important and should be considered as core in future research reports.

British Journal of Community NursingVol. 26, No. Sup3 EditorialWound care in 2021Una AdderleyUna AdderleyDirector, National Wound Care Strategy Programme; Visiting Associate Professor, School of Healthcare, University of LeedsSearch for more papers by this authorUna AdderleyPublished Online:10 Mar 2021https://doi.org/10.12968/bjcn.2021.26.Sup3.S5AboutSectionsView articleView Full TextPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail View article References Guest JF, Fuller GW, Vowden P. Cohort study evaluating the burden of wounds to the UK's National Health Service in 2017/2018: update from 2012/2013. BMJ Open. 2020; 10(12):e045253. https://doi.org/10.1136/bmjopen-2020-045253 Crossref, Medline, Google ScholarGuest JF, Ayoub N, McIlwraith T et al.. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open. 2015; 5(12):e009283. https://doi.org/10.1136/bmjopen-2015-009283 Crossref, Medline, Google Scholar FiguresReferencesRelatedDetails 1 March 2021Volume 26Issue Sup3ISSN (print): 1462-4753ISSN (online): 2052-2215 Metrics History Published online 10 March 2021 Published in print 1 March 2021 Information© MA Healthcare LimitedPDF download

Una Adderley discusses the National Wound Care Strategy Programme's recommendations for the care of patients with lower limb ulcers, which are now being implemented across England.

Lower limb ulceration is common and costly, with evidence of variation in practice and under-use of evidence-based care. This has resulted in poor healing rates and exacerbated costs. Commissioning to achieve better organised care that supports early delivery of evidence-based interventions is needed to improve the management of this very common condition in community and primary care.

Wound care consumes a considerable proportion of NHS resources, particularly for services that deliver healthcare outside hospitals.1 It is estimated that around 50% of community nursing time is spent delivering wound care.2 The burden is considerable for people living with wounds who too often cannot access the right care early enough in their wound care journey. As we move through the Covid pandemic towards recovery, the need to improve wound care is more pressing than ever.

Community nurses often care for patients with sloughy venous leg ulcers. Slough is viewed as a potential infection source and an impediment to healing, but it is unclear if active debridement of slough promotes healing. Using a clinical scenario as a contextual basis, this literature review sought research evidence to answer this clinical question. A strategy based on the ‘4S’ approach was used to identify research evidence. The retrieved evidence included one systematic review, three clinical guidelines and six qualitative and quantitative studies. The analysis suggested that there is no robust evidence to support the routine practice of active debridement of venous leg ulcers to promote healing, and that debridement is associated with increased pain. Since autolytic debridement can be achieved through the application of graduated compression therapy, active debridement may offer no additional benefit.

Background: Venous leg ulceration is common in older adults in the United Kingdom. The gold-standard treatment is compression therapy. There are several compression bandage and hosiery systems that can be prescribed or purchased, but it was unclear what types of compression systems are currently being used to treat venous leg ulceration within the UK. This online scoping survey of registered nurses sought to (1) to identify what compression systems are available across the UK, (2) how frequently these are in use and (3) if there are any restrictions on their use. Results: The results showed that registered nurses who treat patients with venous leg ulceration use a wide range of compression systems. The most frequently used systems are the 'less bulky' two-layer elastic and inelastic compression bandaging systems whilst two-layer hosiery was used less frequently and four-layer bandaging used infrequently. Nurses report that certain compression systems are less accessible through the usual procurement routes but this appears to be related to concerns about competency in application techniques. Conclusions: The data in this survey provides some important insights into the issues around the use of compression therapy for venous leg ulceration in the UK. Limiting access to certain types of compression may promote patient safety but limit patient choice. There may be underuse of the types of compression that promote patient independence, such as hosiery, and over-use of potentially sub-therapeutic therapy such as 'reduced compression'. Overall, this study suggests that further consideration is needed about the provision of compression therapy to UK patients with venous leg ulceration to optimise care and patient choice.

The excess risk of amputation in the diabetic population is well documented. However, approximately half of all amputations in England are in people that do not have diabetes - the remainder being mainly peripheral arterial disease. Whilst the prevalence of foot ulcers in the population without diabetes is significantly lower than their diabetic counterparts, the actual number of people with ulcers, and, therefore, the burden on services, is, the same. In addition to this inequality, the prevalence of amputation is greater in men than women and in the North of England compared with the South. We suggest that whilst diabetes is an important inequality to continue addressing, it is not the only one.

Journal of Wound CareVol. 28, No. 9 Letters on Generic Product SpecificationFree AccessResponse to the open letter Journal of Wound Care (JWC). ‘Major concerns regarding the generic product specification for wound care’ August 2019ABHI Wound Care Sector Group, Surgical Device Manufacturers Association (SDMA)ABHI Wound Care Sector GroupThe ABHI Wound Care Sector Group represents advanced wound care manufacturers, members include: 3M United Kingdom PLC, Advancis Medical, Cardinal Health UK & Ireland, ConvaTec Ltd, KCI Medical Products (An Acelity Company), Cook (UK) Ltd, Inotec AMD Ltd, L&R Medical UK Ltd, Paul Hartmann Ltd, Smith & Nephew, Synapse Electroceutical LtdSearch for more papers by this author, Surgical Device Manufacturers Association (SDMA)The SDMA represents fifteen advanced wound care companies responsible for providing the majority of wound care and associated products to the NHS, members include: Urgo Ltd, KCI Medical Products (Crawford Healthcare & Acelity Ltd), Toiletry Sales Limited, Smith & Nephew UKI, Robinson Healthcare Ltd, Cardinal Health, Coloplast Ltd, Paul Hartman Ltd, L&R, Mölnlycke Health Care, 3M Health Care, H&R Healthcare Ltd, ConvaTec Ltd, EssitySearch for more papers by this authorABHI Wound Care Sector Group; Surgical Device Manufacturers Association (SDMA)Published Online:12 Sep 2019https://doi.org/10.12968/jowc.2019.28.9.562AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareShare onFacebookTwitterLinked InEmail Dear SirsWe read with interest the recent open letter entitled Major concerns regarding the generic product specification for wound care published in the Journal of Wound Care 2019; 28(8). The letter, co-written by nine of the UK's leading wound care clinicians, highlighted shared concerns relating to the recent generic product specification proposals for wound care dressings.We are acutely aware of the financial constraints impacting the NHS and that a generic approach has been adopted for pharmaceuticals. However, generic pharmaceutical products use the same active ingredient as the equivalent original branded drug and are thus almost identical. Adopting this approach for wound care products poses a challenge as the material sources and manufacturing processes often differ significantly with the result that they don't contain a consistent active ingredient. Where the NHS would most benefit from standardisation, is in the approach taken to wound care assessment and care, rather than the products used. Education, training and appropriate investment would enable the clinician to make an informed decision on the type of treatment required. This would lead to greater savings, improved patient outcomes and overall efficiency gains for the system.The wound care industry has always contributed significantly to the education and training of the frontline workforce, we would welcome an opportunity to work with the National Wound Care Strategy to understand how this significant resource can best be co-ordinated and deployed to help both improve patient outcomes and deliver the required efficiency savings.The recent open letter notes the complexity of wounds, and how through limiting the range of available dressings in use, patient care will suffer. Serious consideration should therefore be given to halting the implementation of these proposed changes, particularly given that so many high-profile clinical leaders, who use these products daily, have expressed such apprehension.It is the opinion of wound care manufacturers that ‘genericisation’ of the wound care market would be a serious oversimplification, completely ignoring the complexities of wound care treatment. Wounds by their very nature are multifaceted. Significant consideration must be afforded to their management, with wound size, depth, signs of infection, area of the body and exudate levels just some of the factors requiring attention. Additionally, patient-related factors such as underlying comorbidities, lifestyle and patient concordance can profoundly impact clinical outcomes.For the reasons outlined above, a generic approach for wound care does not work. Wound care is a sector that is fundamentally based on innovation and iteration. Companies, often work in partnership with a clinician or trust to develop bespoke products, using different materials and additives that serve a unique purpose. These mechanisms would be lost under the proposed changes.A transactional approach to procurement, that is framed around short-term cash savings, could actually add to overall treatment cost. It is also at odds with the adoption of a value approach supported within publications such as the ‘Next Steps on the NHS five year forward view’. The 2018 NHS North West Procurement Development Report on Value Based Procurement recognises that if:‘we only focus on short term, margin reductions, we risk losing those suppliers that invest in product and service innovation to improve the value and overall cost of our NHS’.Procurement must be partnership-driven and conducted through value-based methods that recognise savings across the full cycle of care. By focussing on the price of the dressing, rather than overall cost of wound care, the NHS is failing to achieve optimum return on its investment. Only 14% of the complete cost of treating a wound goes on the dressing. Any savings realised by reducing that cost may be countered by lowering the quality of dressings. This could see patients receive less efficient products, that slow down healing and require more regular changes – all of which would ultimately increase total NHS treatment costs. FiguresReferencesRelatedDetails 2 September 2019Volume 28Issue 9ISSN (print): 0969-0700ISSN (online): 2052-2916 Metrics History Published online 12 September 2019 Published in print 2 September 2019 Information© MA Healthcare LimitedPDF download

Background: At present there is no established national minimum data set (MDS) for generic wound assessment in England, which has led to a lack of standardisation and variable assessment criteria being used across the country. This hampers the quality and monitoring of wound healing progress and treatment. Aim: To establish a generic wound assessment MDS to underpin clinical practice. Method: The project comprised 1) a literature review to provide an overview of wound assessment best practice and identify potential assessment criteria for inclusion in the MDS and 2) a structured consensus study using an adapted Research and Development/University of California at Los Angeles Appropriateness method. This incorporated experts in the wound care field considering the evidence of a literature review and their experience to agree the assessment criteria to be included in the MDS. Results: The literature review identified 24 papers that contained criteria which might be considered as part of generic wound assessment. From these papers 68 potential assessment items were identified and the expert group agreed that 37 (relating to general health information, baseline wound information, wound assessment parameters, wound symptoms and specialists) should be included in the MDS. Discussion: Using a structured approach we have developed a generic wound assessment MDS to underpin wound assessment documentation and practice. It is anticipated that the MDS will facilitate a more consistent approach to generic wound assessment practice and support providers and commissioners of care to develop and re-focus services that promote improvements in wound care. (C) 2017 The Authors. Published by Elsevier Ltd on behalf of Tissue Viability Society.

What are the effects of treatments for venous leg ulcers? What are the effects of various interventions for venous leg ulcers?

The annual cost to the NHS for managing the 2.2 million wounds and their associated comorbidities is estimated to be between £4.5 billion and £5.1 billion. Improving the quality of wound care should reduce healthcare spending and improve patients' quality of life. The new NHS England wound care management project, which is part of the Leading Change, Adding Value nursing and midwifery framework, seeks to reduce unwarranted variation in the assessment and treatment of wounds across the patient pathway by developing a number of wound-focussed initiatives. This article introduces the project and outlines the development of an evidence-based wound assessment minimum data set that will be monitored by a wound assessment Commissioning for Quality and Innovation (CQUIN) indicator. This initiative demonstrates the need for good quality economic data to identify clinical issues of concern that can then be addressed by appropriate policy initiatives to improve patient care and make the best possible use of NHS resources.

Objective: The focus of this study was to identify the factors that impact upon the recruitment of participants to research studies in wound care from the community nurses' perspective.Method: A qualitative approach utilising classic grounded theory methodology was used. Semi structured interviews were used to generate data and data analysis was facilitated by using QSR International's NVivo10 qualitative data analysis software (2012).Results: Eight participants consisting of community registered nursing staff of differing levels of seniority took part in the study. Four main themes emerged from the data:knowing about the impact of research studies,knowing about the patient,knowing about the research team and,knowing about the study.Conclusions: There are a number of factors in addition to the eligibility criteria that influence community nurses when identifying potential participants for wound care trials. These factors limit the recruitment pool so may affect the transferability and generalisability of research findings to the intended population. The design of future recruitment strategies and the planning of study initiation training should take these factors into account. (C) 2016 Tissue Viability Society. Published by Elsevier Ltd. All rights reserved.

Background: Venous leg ulcer management in the UK varies significantly. judgements made by nurses contribute to this variability and it is often assumed that specialist nurses make better judgements than non-specialist nurses. This paper compares the judgements of community tissue viability specialist nurses and community generalist nurses; specifically, the ways they use clinical information and their levels of accuracy.Objectives: To compare specialist and non-specialist UK community nurses' clinical information use when managing venous leg ulceration and their levels of accuracy when making diagnoses and judging the need for treatment.Design: Judgement analysis.Setting: UK community and primary care nursing services.Participants: 18 community generalist nurses working in district (home) nursing teams and general practitioner services and 18 community tissue viability specialist nurses.Methods: Data were collected in 2011 and 2012. 18 community generalist nurses and 18 community tissue viability specialist nurses made diagnostic and treatment judgements on 110 clinical scenarios and indicated their confidence in each of their judgements. Scenarios were generated from real patient cases and presented online using text and photographs. An expert panel made judgements, and reached consensus on the same scenarios. These judgements were used as a standard against which to compare the participants. Logistic regression models and correlational statistics were used to generate various indices of judgement "performance": accuracy, consistency, confidence calibration and information use. Differences between groups of nurses with different levels of characteristics linked to expertise were explored using analysis of variance.Results: Specialist nurses had similar cue usage to the generalist nurses but were more accurate when making diagnostic and treatment judgements.Conclusion: It is not obvious why the tissue viability specialist nurses were more accurate. One possible reason might be the greater opportunities for 'deliberate practice' afforded to specialists. However, restricting aspects of practice only to specialist nurses is likely to hinder the judgement performance of generalists. (C) 2015 Elsevier Ltd. All rights reserved.

Venous leg ulceration affects a large proportion of the elderly population and can have a profound impact on quality of life. Most patients with leg ulcers receive care from community nurses who are principally responsible for prescribing decisions in the management of venous leg ulceration. There is evidence to support the use of potable tap water for cleansing. Evidence supports the use of compression bandaging or compression hosiery for all patients with adequate arterial supply to the lower leg. There is also good evidence to support the prescription of oral pentoxifylline, preferably as an adjunct to compression or, for patients unable to tolerate compression, as a stand-alone therapy. The evidence base for dressings is less robust, but simple low-cost, low-adherent dressings are a reasonable first-line choice for under-compression.

VEINES-QOL/Sym is a disease-specific quality of life instrument for use in venous diseases of the leg. Its relative scoring system precludes comparisons between studies. There were very few venous leg ulcer patients in the validation samples. We report a validation study for venous leg ulcers and develop a scoring system which enables comparison between studies.

We all make judgements and decisions every day about what to wear, eat or do. The decisions affect us and the people close to us, while the judgements and decisions in our professional nursing lives have implications for patients and service users.