Cohort study evaluating the burden of wounds to the UK's National Health Service in 2017/2018: update from 2012/2013.

OBJECTIVE: To evaluate the prevalence of wounds managed by the UK's National Health Service (NHS) in 2017/2018 and associated health outcomes, resource use and costs. DESIGN: Retrospective cohort analysis of the electronic records of patients from The Health Improvement Network (THIN) database. SETTING: Primary and secondary care sectors in the UK. PARTICIPANTS: Randomly selected cohort of 3000 patients from the THIN database who had a wound in 2017/2018. PRIMARY AND SECONDARY OUTCOME MEASURES: Patients' characteristics, wound-related health outcomes, healthcare resource use and total NHS cost of patient management. RESULTS: There were an estimated 3.8 million patients with a wound managed by the NHS in 2017/2018, of which 70% healed in the study year; 89% and 49% of acute and chronic wounds healed, respectively. An estimated 59% of chronic wounds healed if there was no evidence of infection compared with 45% if there was a definite or suspected infection. Healing rate of acute wounds was unaffected by the presence of infection. Smoking status appeared to only affect the healing rate of chronic wounds. Annual levels of resource use attributable to wound management included 54.4 million district/community nurse visits, 53.6 million healthcare assistant visits and 28.1 million practice nurse visits. The annual NHS cost of wound management was £8.3 billion, of which £2.7 billion and £5.6 billion were associated with managing healed and unhealed wounds, respectively. Eighty-one per cent of the total annual NHS cost was incurred in the community. CONCLUSION: The annual prevalence of wounds increased by 71% between 2012/2013 and 2017/2018. There was a substantial increase in resource use over this period and patient management cost increased by 48% in real terms. There needs to be a structural change within the NHS in order to manage the increasing demand for wound care and improve patient outcomes.

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial.

INTRODUCTION: Diabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence. METHODS AND ANALYSIS: A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks. ETHICS AND DISSEMINATION: Ethics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN64926597; registered on 6 June 2017.

TIME CDST: an updated tool to address the current challenges in wound care.

Despite the understanding that wounds are a common problem affecting the individual, the health service and society as a whole, there continues to be a lack of a systematic, structured, evidence-based approach to wound management. The TIME principle was first published in 2003, 1 and has since been integrated by many into clinical practice and research. However, this tool has been criticised for its tendency to focus mainly on the wound rather than on the wider issues that the patient is presenting with. At an expert meeting held in London in 2018, this conundrum was addressed and the TIME clinical decision support tool (CDST) was elaborated upon. This article introduces the TIME CDST, explains why it is required and describes how its use is likely to benefit patients, clinicians and health-service organisations. It also explores the framework in detail, and shows why this simple and accessible framework is robust enough to facilitate consistency in the delivery of wound care and better patient outcomes. Finally, it outlines the next steps for the rollout, use and evaluation of the impact of the TIME CDST.

Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study.

OBJECTIVE: To evaluate the patient pathways and associated health outcomes, resource use and corresponding costs attributable to managing unhealed surgical wounds in clinical practice, from initial presentation in the community in the UK. METHODS: This was a retrospective cohort analysis of the records of 707 patients in The Health Improvement Network (THIN) database whose wound failed to heal within 4 weeks of their surgery. Patients' characteristics, wound-related health outcomes and healthcare resource use were quantified, and the total National Health Service (NHS) cost of patient management was estimated at 2015/2016 prices. RESULTS: Inconsistent terminology was used in describing the wounds. 83% of all wounds healed within 12 months from onset of community management, ranging from 86% to 74% of wounds arising from planned and emergency procedures, respectively. Mean time to healing was 4 months per patient. Patients were predominantly managed in the community by nurses and only around a half of all patients who still had a wound at 3 months were recorded as having had a follow-up visit with their surgeon. Up to 68% of all wounds may have been clinically infected at the time of presentation, and 23% of patients subsequently developed a putative wound infection a mean 4 months after initial presentation. Mean NHS cost of wound care over 12 months was £7300 per wound, ranging from £6000 to £13 700 per healed and unhealed wound, respectively. Additionally, the mean NHS cost of managing a wound without any evidence of infection was ~£2000 and the conflated cost of managing a wound with a putative infection ranged from £5000 to £11 200. CONCLUSION: Surgeons are unlikely to be fully aware of the problems surrounding unhealed surgical wounds once patients are discharged into the community, due to inconsistent recording in patients' records coupled with the low rate of follow-up appointments. These findings offer the best evidence available with which to inform policy and budgetary decisions pertaining to managing unhealed surgical wounds in the community.

AVURT: aspirin versus placebo for the treatment of venous leg ulcers - a Phase II pilot randomised controlled trial.

BACKGROUND: Venous leg ulcers (VLUs) are the most common cause of leg ulceration, affecting 1 in 100 adults. VLUs may take many months to heal (25% fail to heal). Estimated prevalence is between 1% and 3% of the elderly population. Compression is the mainstay of treatment and few additional therapies exist to improve healing. Two previous trials have indicated that low-dose aspirin, as an adjunct to standard care, may improve healing time, but these trials were insufficiently robust. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. OBJECTIVES: Primary objective - to assess the effects of 300 mg of aspirin (daily) versus placebo on the time to healing of the reference VLU. Secondary objectives - to assess the feasibility of leading into a larger pragmatic Phase III trial and the safety of aspirin in this population. DESIGN: A multicentred, pilot, Phase II randomised double-blind, parallel-group, placebo-controlled efficacy trial. SETTING: Community leg ulcer clinics or services, hospital outpatient clinics, leg ulcer clinics, tissue viability clinics and wound clinics in England, Wales and Scotland. PARTICIPANTS: Patients aged ≥ 18 years with a chronic VLU (i.e. the VLU is > 6 weeks in duration or the patient has a history of VLU) and who are not regularly taking aspirin. INTERVENTIONS: 300 mg of daily oral aspirin versus placebo. All patients were offered care in accordance with Scottish Intercollegiate Guidelines Network (SIGN) guidance with multicomponent compression therapy aiming to deliver 40 mmHg at the ankle when possible. RANDOMISATION: Participants were allocated in a 1 : 1 (aspirin : placebo) ratio by the Research Pharmacy, St George's University Hospitals NHS Foundation Trust, using a randomisation schedule generated in advance by the investigational medicinal product manufacturer. Randomisation was stratified according to ulcer size (≤ 5cm2 or > 5cm2). MAIN OUTCOME MEASURE: The primary outcome was time to healing of the largest eligible ulcer (reference ulcer). FEASIBILITY RESULTS ­ RECRUITMENT: 27 patients were recruited from eight sites over a period of 8 months. The target of 100 patients was not achieved and two sites did not recruit. Barriers to recruitment included a short recruitment window and a large proportion of participants failing to meet the eligibility criteria. RESULTS: The average age of the 27 randomised participants (placebo, n = 13; aspirin, n = 14) was 62 years (standard deviation 13 years), and two-thirds were male (n = 18). Participants had their reference ulcer for a median of 15 months, and the median size of ulcer was 17.1 cm2. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis for log-ulcer area and duration (hazard ratio 0.58, 95% confidence interval 0.18 to 1.85; p = 0.357). One expected, related serious adverse event was recorded for a participant in the aspirin group. LIMITATIONS: The trial under-recruited because many patients did not meet the eligibility criteria. CONCLUSIONS: There was no evidence that aspirin was efficacious in hastening the healing of chronic VLUs. It can be concluded that a larger Phase III (effectiveness) trial would not be feasible. TRIAL REGISTRATION: Clinical Trials.gov NCT02333123; European Clinical Trials Database (EudraCT) 2014-003979-39. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 55. See the NIHR Journals Library website for further project information.

Cohort study evaluating pressure ulcer management in clinical practice in the UK following initial presentation in the community: costs and outcomes.

OBJECTIVES: The aim of this study was to estimate the patterns of care and annual levels of healthcare resource use attributable to managing pressure ulcers (PUs) in clinical practice in the community by the UK's National Health Service (NHS), and the associated costs of patient management. METHODS: This was a retrospective cohort analysis of the records of 209 patients identified within a randomly selected population of 6000 patients with any type of wound obtained from The Health Improvement Network (THIN) Database, who developed a PU in the community and excluded hospital-acquired PUs. Patients' characteristics, wound-related health outcomes and healthcare resource use were quantified over 12 months from initial presentation, and the corresponding total NHS cost of patient management was estimated at 2015/2016 prices. RESULTS: 50% of all the PUs healed within 12 months from initial presentation, but this varied between 100% for category 1 ulcers and 21% for category 4 ulcers. The mean time to healing ranged from 1.0 month for a category 1 ulcer to 8 months for a category 3/4 ulcer and 10 months for an unstageable ulcer. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 53% of all the ulcers may have been clinically infected at the time of presentation, and 35% of patients subsequently developed a putative wound infection a mean 4.7 months after initial presentation. The mean NHS cost of wound care over 12 months ranged from £1400 for a category 1 ulcer to >£8500 for the other categories of ulcer. Additionally, the cost of managing an unhealed ulcer was 2.4 times more than that of managing a healed ulcer (mean of £5140 vs £12 300 per ulcer). CONCLUSION: This study provides important insights into a number of aspects of PU management in clinical practice in the community that have been difficult to ascertain from other studies, and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.

Cost-effectiveness of an electroceutical device in treating non-healing venous leg ulcers: results of an RCT.

OBJECTIVE: To estimate the cost-effectiveness of an externally applied electroceutical (EAE) device, Accel-Heal, in treating non-healing venous leg ulcers (VLUs) in the UK. METHOD: This was a prospective, randomised, double-blind, placebo-controlled, multi-centre study of patients aged ≥18 years with a non-healing VLU. Patients were randomised in the ratio of 1:1 to receive six units of the EAE (consisting of a self-contained, programmed electric microcurrent generator and two skin contact pads) or an identical-looking placebo device over 12 consecutive days. Patients were followed-up for 24 weeks from randomisation, during which time patients received wound care according to the local standard care pathway, completed health-related quality of life (HRQoL) instruments, and health-care resource use was measured. The cost-effectiveness of the EAE device was estimated at 2015/16 prices in those patients who fulfilled the study's inclusion and exclusion criteria (economic analysis population). RESULTS: At 24 weeks after randomisation, 34% and 30% of VLUs in the EAE and placebo groups in the economic analysis population, respectively, had healed. The time-to-healing was a mean of 2.6 and 3.5 months in the EAE and placebo groups, respectively. The area of the wounds that healed in the EAE group was nearly twice that of those in the placebo group (mean: 13.3 versus 7.7cm2 per VLU). Additionally, the pre-randomised duration of the wounds that healed in the EAE group was double that of those in the placebo group (mean: 2.6 versus 1.2 years per VLU). By the end of the study, EAE-treated patients reported less pain, more social functioning and greater overall wellbeing/satisfaction than placebo-treated patients. None of these differences reached statistical significance, but they may be important to patients. There were no significant differences in health-care resource use between the two groups. The incremental cost per quality-adjusted life year (QALY) gained with the EAE device was £4480 at eight weeks, decreasing to £2265 at 16 weeks and -£2388 (dominant) at 24 weeks. The study was confounded by unwarranted variation in patient management between centres and between individual clinicians within each centre. CONCLUSION: Despite the unwarranted variation in the provision of wound care observed in this study, the use of the EAE device resulted in some improved clinical outcomes and patient-reported outcomes, for the same or less cost as standard care, by 24 weeks. Clinicians managing VLUs may wish to consider the findings from this study when making treatment decisions.

Potential cost-effectiveness of using a collagen-containing dressing in managing diabetic foot ulcers in the UK.

OBJECTIVE: To estimate whether a collagen-containing dressing could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of diabetic foot ulcers (DFUs). METHOD: A decision model depicting the management of a DFU was constructed and populated with a combination of published clinical outcomes, resource use estimates and utilities for DFUs. The model estimated the incremental cost-effectiveness of a collagen-containing dressing plus standard care compared with standard care alone over a period of four months in terms of the incremental cost per quality-adjusted life year (QALY) gained. RESULTS: Treatment of DFUs of >6 months duration with a collagen-containing dressing plus standard care instead of standard care alone is expected to increase the probability of healing from 0.08 to 0.53 by four months and increase health-related quality of life at four months from 0.156 to 0.163 QALYs per patient. Additionally, treatment with a collagen-containing dressing has the potential to reduce management costs by 22% over four months when compared with standard care alone (from £2897 to £2255 per patient). Treatment of new DFUs with a collagen-containing dressing plus standard care instead of standard care alone was also found to improve outcomes for less cost. CONCLUSION: Within the study's limitations, use of a collagen-containing dressing plus standard care instead of standard care alone potentially affords the NHS a cost-effective (dominant) treatment for both non-healing and new DFUs, since it improves outcomes for less cost. Hence, protocols should be established which enable clinicians to effectively introduce collagen-containing dressings into care pathways and monitor response to treatment.

The importance of accurate methodology in ABPI calculation when assessing lower limb wounds.

Recent health economic publications have highlighted the cost of wound care and demonstrated the important role played by community and practice nurses in delivering care. Leg ulcers form a significant proportion of the wounds managed in the community. Data indicates that many patients are managed with no specific diagnosis or without calculation of the ankle brachial pressure index (ABPI), despite care guidelines emphasising the importance of a full assessment including Doppler ABPI calculation in patient management. This article highlights the important role Doppler ABPI plays in patient assessment and describes the methodology, focusing on the importance of correct application of the technique if reliable reproducible results are to be obtained. The rationale for obtaining blood pressure readings from both arms is discussed, and the possible error resulting from reliance on single upper limb blood pressure measurement for both manual and automated ABPI calculation is highlighted and its impact on ABPI calculation illustrated.

Cost-effectiveness of using a collagen-containing dressing plus compression therapy in non-healing venous leg ulcers.

OBJECTIVE: To estimate whether collagen-containing dressings could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of non-healing venous leg ulcers (VLUs). METHOD: This was a modelling study performed from the perspective of the UK's NHS. A combination of published clinical outcomes, resource utilisation estimates and utilities for VLUs enabled the construction of a decision model, depicting the management of a chronic VLU with standard care or with a collagen-containing dressing plus compression therapy followed by standard care, over a period of 6 months. The model estimated the incremental cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2015/16 prices. RESULTS: The treatment of VLUs of >6 months' duration with a collagen-containing dressing plus compression therapy followed by standard care, instead of standard care, is expected to increase the probability of healing from 0.11 to 0.49 by 6 months and increase health-related quality of life at 6 months from 0.331 to 0.373 QALYs per patient. Additionally, treatment with a collagen-containing dressing plus compression therapy followed by standard care has the potential to reduce management costs by 40% over 6 months when compared with standard care (from £6328 to £3789 per patient). CONCLUSION: Within the study's limitations, including a collagen-containing dressing into a standard care protocol compared with standard care potentially affords the NHS a cost-effective (dominant) treatment since it improves outcomes for less cost.

Venous leg ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions.

Diabetic foot ulcer management in clinical practice in the UK: costs and outcomes.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing diabetic foot ulcers (DFUs) in clinical practice by the UK's National Health Service (NHS), and the associated costs of patient management. This was a retrospective cohort analysis of the records of 130 patients with a newly diagnosed DFU in The Health Improvement Network (THIN) database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015-2016 prices. Patients were predominantly managed in the community by nurses, with minimal clinical involvement of specialist physicians. 5% of patients saw a podiatrist, and 5% received a pressure-offloading device. Additionally, 17% of patients had at least one amputation within the first 12 months from initial presentation of their DFU. 14% of DFUs were documented as being clinically infected at initial presentation, although an additional 31% of patients were prescribed an antimicrobial dressing at the time of presentation. Of all the DFUs, 35% healed within 12 months, and the mean time to healing was 4·4 months. Over the study period, 48% of all patients received at least one prescription for a compression system, but significantly more patients healed if they never received compression (67% versus 16%; P < 0·001). The mean NHS cost of wound care over 12 months was an estimated £7800 per DFU (of which 13% was attributable to amputations), ranging from £2140 to £8800 per healed and unhealed DFU, respectively, and £16 900 per amputated wound. Consolidated medical records from a primary care held database provided 'real-world evidence' highlighting the consequences of inefficient and inadequate management of DFUs in clinical practice in the UK. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (i) wound prevention, (ii) improving wound-healing rates and (iii) reducing infection and amputation rates.

Development of a generic wound care assessment minimum data set.

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.

EWMA Document: Negative Pressure Wound Therapy.

1. Introduction Since its introduction in clinical practice in the early 1990's negative pressure wounds therapy (NPWT) has become widely used in the management of complex wounds in both inpatient and outpatient care.1 NPWT has been described as a effective treatment for wounds of many different aetiologies2,3 and suggested as a gold standard for treatment of wounds such as open abdominal wounds,4-6 dehisced sternal wounds following cardiac surgery7,8 and as a valuable agent in complex non-healing wounds.9,10 Increasingly, NPWT is being applied in the primary and home-care setting, where it is described as having the potential to improve the efficacy of wound management and help reduce the reliance on hospital-based care.11 While the potential of NPWT is promising and the clinical use of the treatment is widespread, highlevel evidence of its effectiveness and economic benefits remain sparse.12-14 The ongoing controversy regarding high-level evidence in wound care in general is well known. There is a consensus that clinical practice should be evidence-based, which can be difficult to achieve due to confusion about the value of the various approaches to wound management; however, we have to rely on the best available evidence. The need to review wound strategies and treatments in order to reduce the burden of care in an efficient way is urgent. If patients at risk of delayed wound healing are identified earlier and aggressive interventions are taken before the wound deteriorates and complications occur, both patient morbidity and health-care costs can be significantly reduced. There is further a fundamental confusion over the best way to evaluate the effectiveness of interventions in this complex patient population. This is illustrated by reviews of the value of various treatment strategies for non-healing wounds, which have highlighted methodological inconsistencies in primary research. This situation is confounded by differences in the advice given by regulatory and reimbursement bodies in various countries regarding both study design and the ways in which results are interpreted. In response to this confusion, the European Wound Management Association (EWMA) has been publishing a number of interdisciplinary documents15-19 with the intention of highlighting: The nature and extent of the problem for wound management: from the clinical perspective as well as that of care givers and the patients Evidence-based practice as an integration of clinical expertise with the best available clinical evidence from systematic research The nature and extent of the problem for wound management: from the policy maker and healthcare system perspectives The controversy regarding the value of various approaches to wound management and care is illustrated by the case of NPWT, synonymous with topical negative pressure or vacuum therapy and cited as branded VAC (vacuum-assisted closure) therapy. This is a mode of therapy used to encourage wound healing. It is used as a primary treatment of chronic wounds, in complex acute wounds and as an adjunct for temporary closure and wound bed preparation preceding surgical procedures such as skin grafts and flap surgery. Aim An increasing number of papers on the effect of NPWT are being published. However, due to the low evidence level the treatment remains controversial from the policy maker and health-care system's points of view-particularly with regard to evidence-based medicine. In response EWMA has established an interdisciplinary working group to describe the present knowledge with regard to NPWT and provide overview of its implications for organisation of care, documentation, communication, patient safety, and health economic aspects. These goals will be achieved by the following: Present the rational and scientific support for each delivered statement Uncover controversies and issues related to the use of NPWT in wound management Implications of implementing NPWT as a treatment strategy in the health-care system Provide information and offer perspectives of NPWT from the viewpoints of health-care staff, policy makers, politicians, industry, patients and hospital administrators who are indirectly or directly involved in wound management.

Health economic burden that different wound types impose on the UK's National Health Service.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to the management of different wound types by the UK's National Health Service (NHS) in 2012/2013 and the annual costs incurred by the NHS in managing them. This was a retrospective cohort analysis of the records of 2000 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and all health care resource use were quantified, and the total NHS cost of patient management was estimated at 2013/2014 prices. The NHS managed an estimated 2·2 million patients with a wound during 2012/2013. Patients were predominantly managed in the community by general practitioners (GPs) and nurses. The annual NHS cost varied between £1·94 billion for managing 731 000 leg ulcers and £89·6 million for managing 87 000 burns, and associated comorbidities. Sixty-one percent of all wounds were shown to heal in an average year. Resource use associated with managing the unhealed wounds was substantially greater than that of managing the healed wounds (e.g. 20% more practice nurse visits, 104% more community nurse visits). Consequently, the annual cost of managing wounds that healed in the study period was estimated to be £2·1 billion compared with £3·2 billion for the 39% of wounds that did not heal within the study year. Within the study period, the cost per healed wound ranged from £698 to £3998 per patient and that of an unhealed wound ranged from £1719 to £5976 per patient. Hence, the patient care cost of an unhealed wound was a mean 135% more than that of a healed wound. Real-world evidence highlights the substantial burden that wounds impose on the NHS in an average year. Clinical and economic benefits to both patients and the NHS could accrue from strategies that focus on (a) wound prevention, (b) accurate diagnosis and (c) improving wound-healing rates.

Concordance in diabetic foot ulceration: a cross-sectional study of agreement between wound swabbing and tissue sampling in infected ulcers.

BACKGROUND: There is inadequate evidence to advise clinicians on the relative merits of swabbing versus tissue sampling of infected diabetic foot ulcers (DFUs). OBJECTIVES: To determine (1) concordance between culture results from wound swabs and tissue samples from the same ulcer; (2) whether or not differences in bacterial profiles from swabs and tissue samples are clinically relevant; (3) concordance between results from conventional culture versus polymerase chain reaction (PCR); and (4) prognosis for patients with an infected DFU at 12 months' follow-up. METHODS: This was a cross-sectional, multicentre study involving patients with diabetes and a foot ulcer that was deemed to be infected by their clinician. Microbiology specimens for culture were taken contemporaneously by swab and by tissue sampling from the same wound. In a substudy, specimens were also processed by PCR. A virtual 'blinded' clinical review compared the appropriateness of patients' initial antibiotic regimens based on the results of swab and tissue specimens. Patients' case notes were reviewed at 12 months to assess prognosis. RESULTS: The main study recruited 400 patients, with 247 patients in the clinical review. There were 12 patients in the PCR study and 299 patients in the prognosis study. Patients' median age was 63 years (range 26-99 years), their diabetes duration was 15 years (range 2 weeks-57 years), and their index ulcer duration was 1.8 months (range 3 days-12 years). Half of the ulcers were neuropathic and the remainder were ischaemic/neuroischaemic. Tissue results reported more than one pathogen in significantly more specimens than swabs {86.1% vs. 70.1% of patients, 15.9% difference [95% confidence interval (CI) 11.8% to 20.1%], McNemar's p-value < 0.0001}. The two sampling techniques reported a difference in the identity of pathogens for 58% of patients. The number of pathogens differed in 50.4% of patients. In the clinical review study, clinicians agreed on the need for a change in therapy for 73.3% of patients (considering swab and tissue results separately), but significantly more tissue than swab samples required a change in therapy. Compared with traditional culture, the PCR technique reported additional pathogens for both swab and tissue samples in six (50%) patients and reported the same pathogens in four (33.3%) patients and different pathogens in two (16.7%) patients. The estimated healing rate was 44.5% (95% CI 38.9% to 50.1%). At 12 months post sampling, 45 (15.1%) patients had died, 52 (17.4%) patients had a lower-extremity ipsilateral amputation and 18 (6.0%) patients had revascularisation surgery. LIMITATIONS: We did not investigate the potential impact of microbiological information on care. We cannot determine if the improved information yield from tissue sampling is attributable to sample collection, sample handling, processing or reporting. CONCLUSIONS: Tissue sampling reported both more pathogens and more organisms overall than swabbing. Both techniques missed some organisms, with tissue sampling missing fewer than swabbing. Results from tissue sampling more frequently led to a (virtual) recommended change in therapy. Long-term prognosis for patients with an infected foot ulcer was poor. FUTURE WORK: Research is needed to determine the effect of sampling/processing techniques on clinical outcomes and antibiotic stewardship. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

NHS generic project: response from the wound care community.

This series of letters outlines the response from MA Healthcare, key opinion leaders, and industry to the news that the Government is planning to introduce a generic project for wound dressings, limiting products to three main suppliers.

Health economic burden that wounds impose on the National Health Service in the UK.

OBJECTIVE: To estimate the prevalence of wounds managed by the UK's National Health Service (NHS) in 2012/2013 and the annual levels of healthcare resource use attributable to their management and corresponding costs. METHODS: This was a retrospective cohort analysis of the records of patients in The Health Improvement Network (THIN) Database. Records of 1000 adult patients who had a wound in 2012/2013 (cases) were randomly selected and matched with 1000 patients with no history of a wound (controls). Patients' characteristics, wound-related health outcomes and all healthcare resource use were quantified and the total NHS cost of patient management was estimated at 2013/2014 prices. RESULTS: Patients' mean age was 69.0 years and 45% were male. 76% of patients presented with a new wound in the study year and 61% of wounds healed during the study year. Nutritional deficiency (OR 0.53; p<0.001) and diabetes (OR 0.65; p<0.001) were independent risk factors for non-healing. There were an estimated 2.2 million wounds managed by the NHS in 2012/2013. Annual levels of resource use attributable to managing these wounds and associated comorbidities included 18.6 million practice nurse visits, 10.9 million community nurse visits, 7.7 million GP visits and 3.4 million hospital outpatient visits. The annual NHS cost of managing these wounds and associated comorbidities was £5.3 billion. This was reduced to between £5.1 and £4.5 billion after adjusting for comorbidities. CONCLUSIONS: Real world evidence highlights wound management is predominantly a nurse-led discipline. Approximately 30% of wounds lacked a differential diagnosis, indicative of practical difficulties experienced by non-specialist clinicians. Wounds impose a substantial health economic burden on the UK's NHS, comparable to that of managing obesity (£5.0 billion). Clinical and economic benefits could accrue from improved systems of care and an increased awareness of the impact that wounds impose on patients and the NHS.

NHS generic project: response from the wound care community.

This series of letters outlines the response from MA Healthcare, key opinion leaders and industry to the news that the Government is planning to introduce a generic project for wound dressings.