Barriers and facilitators to use of compression therapy by people with venous leg ulcers: A qualitative exploration.

AIMS: To explore barriers to, and facilitators of, adherence to compression therapy, from the perspective of people with venous leg ulcers. DESIGN: An interpretive, qualitative, descriptive study involving interviews with patients. METHODS: Participants were purposively sampled from respondents to a survey exploring attitudes to compression therapy in people with venous leg ulcers. Sampling continued until data saturation: 25 interviews between December 2019 and July 2020. Inductive thematic analysis of interview transcripts was undertaken to create a framework for the data, followed by deductive analysis informed by the Common-Sense Model of Self-Regulation. RESULTS: A range of knowledge and understanding about the cause of venous leg ulcers and the mechanisms of compression therapy was demonstrated, which was not particularly related to adherence. Participants talked about their experience with different compression methods and their concerns about the length of time healing could take. They also spoke about aspects of the organization of services which affected their care. CONCLUSION: Identifying specific, individual barriers/facilitators to compression therapy is not simple, rather factors combine to make adherence more or less likely or possible. There was no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; different compression therapies presented different challenges for patients; unintentional non-adherence was frequently mentioned; and the organization of services could impact on adherence. Ways in which people could be supported to adhere to compression therapy are indicated. Implications for practice include issues relating to communication with patients; taking into account patients' lifestyles and ensuring that they know about useful 'aids'; providing services that are accessible and provide continuity of appropriately trained staff; minimizing unintentional non-adherence; and acknowledging that healthcare professionals will always need to support/advise those who cannot tolerate compression. IMPACT: Compression therapy is a cost-effective, evidence-based treatment for venous leg ulcers. However, there is evidence that patients do not always adhere to this therapy and there is limited research investigating reasons why patients do not wear compression. The study found no clear relationship between an understanding of the cause of VLUs or the mechanism of compression therapy and adherence; that different compression therapies presented different challenges for patients; that unintentional non-adherence was frequently mentioned and that the organization of services could impact on adherence. Attending to these findings offers the opportunity to increase the proportion of people undergoing appropriate compression therapy and achieving complete wound healing, the main outcome desired by this group. PATIENT/PUBLIC CONTRIBUTION: A patient representative sits on the Study Steering Group, contributing to the work from developing the study protocol and interview schedule to interpretation and discussion of findings. Members of a Wounds Research Patient and Public Involvement Forum were consulted about interview questions.

Negative pressure wound therapy for surgical wounds healing by primary closure.

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 January 2021, 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 technology reports. There were no restrictions on language, publication date or study setting. 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. 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. Our primary outcomes were SSI, mortality, and wound dehiscence. MAIN RESULTS: In this fourth update, we added 18 new randomised controlled trials (RCTs) and one new economic study, resulting in a total of 62 RCTs (13,340 included participants) and six economic studies. Studies evaluated NPWT in a wide range of surgeries, including orthopaedic, obstetric, vascular and general procedures. All studies compared NPWT with standard dressings. Most studies had unclear or high risk of bias for at least one key domain. Primary outcomes Eleven studies (6384 participants) which reported mortality were pooled. There is low-certainty evidence showing there may be a reduced risk of death after surgery for people treated with NPWT (0.84%) compared with standard dressings (1.17%) but there is uncertainty around this as confidence intervals include risk of benefits and harm; risk ratio (RR) 0.78 (95% CI 0.47 to 1.30; I2 = 0%). Fifty-four studies reported SSI; 44 studies (11,403 participants) were pooled. There is moderate-certainty evidence that NPWT probably results in fewer SSIs (8.7% of participants) than treatment with standard dressings (11.75%) after surgery; RR 0.73 (95% CI 0.63 to 0.85; I2 = 29%). Thirty studies reported wound dehiscence; 23 studies (8724 participants) were pooled. There is moderate-certainty evidence that there is probably little or no difference in dehiscence between people treated with NPWT (6.62%) and those treated with standard dressing (6.97%), although there is imprecision around the estimate that includes risk of benefit and harms; RR 0.97 (95% CI 0.82 to 1.16; I2 = 4%). Evidence was downgraded for imprecision, risk of bias, or a combination of these. Secondary outcomes There is low-certainty evidence for the outcomes of reoperation and seroma; in each case, confidence intervals included both benefit and harm. There may be a reduced risk of reoperation favouring the standard dressing arm, but this was imprecise: RR 1.13 (95% CI 0.91 to 1.41; I2 = 2%; 18 trials; 6272 participants). There may be a reduced risk of seroma for people treated with NPWT but this is imprecise: the RR was 0.82 (95% CI 0.65 to 1.05; I2 = 0%; 15 trials; 5436 participants). For skin blisters, there is low-certainty evidence that people treated with NPWT may be more likely to develop skin blisters compared with those treated with standard dressing (RR 3.55; 95% CI 1.43 to 8.77; I2 = 74%; 11 trials; 5015 participants). The effect of NPWT on haematoma is uncertain (RR 0.79; 95 % CI 0.48 to 1.30; I2 = 0%; 17 trials; 5909 participants; very low-certainty evidence). There is low-certainty evidence of little to no difference in reported pain between groups. Pain was measured in different ways and most studies could not be pooled; this GRADE assessment is based on all fourteen trials reporting pain; the pooled RR for the proportion of participants who experienced pain was 1.52 (95% CI 0.20, 11.31; I2 = 34%; two studies; 632 participants). Cost-effectiveness Six economic studies, based wholly or partially on trials in our review, assessed the cost-effectiveness of NPWT compared with standard care. They considered NPWT in five indications: caesarean sections in obese women; surgery for lower limb fracture; knee/hip arthroplasty; coronary artery bypass grafts; and vascular surgery with inguinal incisions. They calculated quality-adjusted life-years or an equivalent, and produced estimates of the treatments' relative cost-effectiveness. The reporting quality was good but the evidence certainty 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-to-pay 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 with primary closure of their surgical wound and treated prophylactically with NPWT following surgery probably experience fewer SSIs  than people treated with standard dressings but there is probably no difference in wound dehiscence (moderate-certainty evidence). There may be a reduced risk of death after surgery for people treated with NPWT compared with standard dressings but there is uncertainty around this as confidence intervals include risk of benefit and harm (low-certainty evidence). People treated with NPWT may experience more instances of skin blistering compared with standard dressing treatment (low-certainty evidence). There are no clear differences in other secondary outcomes where most evidence is low or very low-certainty. 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.

Health service costs of treating venous leg ulcers in the UK: evidence from a cross-sectional survey based in the north west of England.

OBJECTIVES: To estimate and examine the direct healthcare costs of treating people with open venous leg ulcers in the UK. DESIGN: Cost-of-illness study. SETTING: A cross-sectional survey of nine National Health Service community locales over 2-week periods in 2015/2016. METHODS: We examined the resource use and prevalence of venous leg ulcer treatment in the community. Examination of variation in these obtained costs was performed by ordinary least squares regression. We used additional resource use information from a randomised control trial and extrapolated costs to the UK for an annual period. RESULTS: The average 2-week per person cost of treating patients where a venous leg ulceration was the primary (most severe) wound was estimated at £166.39 (95% CI £157.78 to £175.00) with community staff time making up over half of this amount. Costs were higher where antimicrobial dressings were used and where wound care was delivered in the home. Among those with any recorded venous leg ulcer (primary and non-primary), we derived a point prevalence of 3.2 per 10 000 population and estimated that the annual prevalence could be no greater than 82.4 per 10 000 population. We estimated that the national cost of treating a venous leg ulcer was £102 million with a per person annual cost at £4787.70. CONCLUSION: Our point prevalence figures are in line with the literature. However, our annual prevalence estimations and costs are far lower than those reported in recent literature which suggests that the costs of treating venous leg ulcers are lower than previously thought. Movement towards routinely collected and useable community care activity would help provide a transparent and deeper understanding of the scale and cost of wound care in the UK.

Epidemiology and disease burden of complex wounds for inpatients in China: an observational study from Sichuan province.

OBJECTIVES: To investigate the period prevalence of complex wounds among the overall inpatients, and the impact of complex wounds on inpatient health expense and length of hospital stay (LOS). DESIGN: An observational study. SETTING: 6056 healthcare institutions across Sichuan province in China. PARTICIPANTS: This study included 4 033 763 people admitted to healthcare institutions during 1 September 2018 and 31 December 2018. RESULTS: The point prevalence of complex wounds was 4.07 per 1000 among inpatients in Sichuan. The most common complex wounds were pressure ulcers (1.47 per 1000 among inpatients). Older, male, Han ethnic groups and retired people were most likely to suffer from complex wounds. The median LOS was longer for those with complex wounds as their main condition of treatment compared with all-cause admissions in Sichuan (12 days compared with 7 days; p<0.001). The median cost of care for people with complex wounds was higher than for admission for any cause (¥6500.18 compared with ¥3337.16; p<0.001). People with pressure ulcers had the longest LOS, while people with ulcers related to diabetes incurred the highest costs. CONCLUSIONS: Complex wounds, especially pressure ulcers, are common in Sichuan province and their presence is associated with significantly longer lengths of hospital stay and higher medical costs. Additionally, this study only included admitted inpatients during the sampling time period, hence the prevalence of complex wounds may be underestimated. The high prevalence rate and heavy direct and indirect disease burden of complex wounds indicate that health policies for early detection and prevention of complex wounds in elders are urgently needed.

Negative pressure wound therapy for surgical wounds healing by primary closure.

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 technology reports. There were no restrictions on language, publication date or study setting. 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. 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 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-to-pay 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.

Negative pressure wound therapy for surgical wounds healing by primary closure.

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 technology reports. There were no restrictions on language, publication date or study setting. 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. 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 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-to-pay 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.

Nurses' and surgeons' views and experiences of surgical wounds healing by secondary intention: A qualitative study.

AIMS AND OBJECTIVES: To explore surgeons' and nurses' perspectives of managing surgical wounds healing by secondary intention. BACKGROUND: Every year, more than 10 million surgical operations are performed in the NHS in the UK. Most surgical wounds heal by primary intention, where the edges of the wound are brought together with staples, sutures, adhesive glue or clips. Sometimes wounds are deliberately left open to heal, from the base up, known as "healing by secondary intention." These wounds are often slow to heal, prone to infection and complex to manage. DESIGN: A qualitative, descriptive approach, using semi-structured interviews. METHODS: Interviews with five (general, vascular and plastic) surgeons and 7 nurses (3 tissue viability nurses, 2 district and 1 community nurse, and 1 hospital nurse) working in hospital and community care settings in two locations in the north of England. Data analysis followed the recommended sequential steps of "Framework" approach. Consolidated criteria for reporting qualitative research guided the study report. RESULTS: Participants reported that the main types of wounds healing by secondary intention that they manage are extensive abdominal cavity wounds; open wounds relating to treatment for pilonidal sinus; large open wounds on the feet of patients with diabetes; and axilla and groin wounds, associated with removal of lymph nodes for cancer. Infection and prolonged time to healing were the main challenges. Negative pressure wound therapy was the most favoured treatment option. CONCLUSIONS: Negative pressure wound therapy was advocated by professionals despite a lack of research evidence indicating clinical or cost-effectiveness. Our findings underscore the need for rigorous evaluation of negative pressure wound therapy, and other wound care treatments, through studies that include economic evaluation. RELEVANCE FOR CLINICAL PRACTICE: Clinical decision-making in wound care could be optimised through further robust studies to inform practitioners about the cost-effectiveness of available treatments.

Use of antimicrobial dressings in England and the association with published clinical guidance: interrupted time series analysis.

OBJECTIVES: In healthcare systems, practices and products of unproven value and cost-effectiveness can decrease value and increase waste. Using the management of complex wounds, this study investigates temporal trends in the use of antimicrobials dressings, places this in the context of available evidence and discusses the potential impacts on the UK National Health Service (NHS). DESIGN: Secondary descriptive and interrupted time series (ITS) analysis of NHS prescription data. SETTING: Prescribing Cost Analysis (PCA) details all NHS prescriptions dispensed in the community in England. INTERVENTIONS: An ITS design was used to compare annual changes in the expenditure and use of antimicrobial and non-antimicrobial dressings before and after the publication of the 'intervention' of key evidence-based Scottish Intercollegiate Guidelines Network (SIGN) guidance in 2010. PRIMARY AND SECONDARY OUTCOME MEASURES: Trends in use and expenditure of antimicrobial dressings in relation to published clinical guidance. RESULTS: There was a large increase in the prescribing of, and expenditure on, antimicrobial wound dressings between 1997 and 2016. In 1997, the total number of dressings prescribed was 5 792 700; increasing to 11 447 102 in 2009 with expenditure increasing from £1 960 386 to £32 841 263. During the year of the SIGN intervention (2010), there was a significant drop in the use of silver but there was no consistent ongoing reduction from 2011 to 2015. CONCLUSIONS: Prescribing data can be used to identify products of unproven benefit, which also impose a significant financial burden. This study quantifies the huge increase in the use of antimicrobial wound dressings over a 20-year period despite the lack of compelling evidence to support their routine use. There is some suggestion, however that the use and expenditure decreased after the publication of key guidance. Routine data can be used to as part of more systematic efforts to increase value and reduce waste in health systems.

Three wound-dressing strategies to reduce surgical site infection after abdominal surgery: the Bluebelle feasibility study and pilot RCT.

BACKGROUND: Surgical site infection (SSI) affects up to 20% of people with a primary closed wound after surgery. Wound dressings may reduce SSI. OBJECTIVE: To assess the feasibility of a multicentre randomised controlled trial (RCT) to evaluate the effectiveness and cost-effectiveness of dressing types or no dressing to reduce SSI in primary surgical wounds. DESIGN: Phase A - semistructured interviews, outcome measure development, practice survey, literature reviews and value-of-information analysis. Phase B - pilot RCT with qualitative research and questionnaire validation. Patients and the public were involved. SETTING: Usual NHS care. PARTICIPANTS: Patients undergoing elective/non-elective abdominal surgery, including caesarean section. INTERVENTIONS: Phase A - none. Phase B - simple dressing, glue-as-a-dressing (tissue adhesive) or 'no dressing'. MAIN OUTCOME MEASURES: Phase A - pilot RCT design; SSI, patient experience and wound management questionnaires; dressing practices; and value-of-information of a RCT. Phase B - participants screened, proportions consented/randomised; acceptability of interventions; adherence; retention; validity and reliability of SSI measure; and cost drivers. DATA SOURCES: Phase A - interviews with patients and health-care professionals (HCPs), narrative data from published RCTs and data about dressing practices. Phase B - participants and HCPs in five hospitals. RESULTS: Phase A - we interviewed 102 participants. HCPs interpreted 'dressing' variably and reported using available products. HCPs suggested practical/clinical reasons for dressing use, acknowledged the weak evidence base and felt that a RCT including a 'no dressing' group was acceptable. A survey showed that 68% of 1769 wounds (727 participants) had simple dressings and 27% had glue-as-a-dressing. Dressings were used similarly in elective and non-elective surgery. The SSI questionnaire was developed from a content analysis of existing SSI tools and interviews, yielding 19 domains and 16 items. A main RCT would be valuable to the NHS at a willingness to pay of £20,000 per quality-adjusted life-year. Phase B - from 4 March 2016 to 30 November 2016, we approached 862 patients for the pilot RCT; 81.1% were eligible, 59.4% consented and 394 were randomised (simple, n = 133; glue, n = 129; no dressing, n = 132); non-adherence was 3 out of 133, 8 out of 129 and 20 out of 132, respectively. SSI occurred in 51 out of 281 participants. We interviewed 55 participants. All dressing strategies were acceptable to stakeholders, with no indication that adherence was problematic. Adherence aids and patients' understanding of their allocated dressing appeared to be key. The SSI questionnaire response rate overall was 67.2%. Items in the SSI questionnaire fitted a single scale, which had good reliability (test-retest and Cronbach's alpha of > 0.7) and diagnostic accuracy (c-statistic = 0.906). The key cost drivers were hospital appointments, dressings and redressings, use of new medicines and primary care appointments. LIMITATIONS: Multiple activities, often in parallel, were challenging to co-ordinate. An amendment took 4 months, restricting recruitment to the pilot RCT. Only 67% of participants completed the SSI questionnaire. We could not implement photography in theatres. CONCLUSIONS: A main RCT of dressing strategies is feasible and would be valuable to the NHS. The SSI questionnaire is sufficiently accurate to be used as the primary outcome. A main trial with three groups (as in the pilot) would be valuable to the NHS, using a primary outcome of SSI at discharge and patient-reported SSI symptoms at 4-8 weeks. TRIAL REGISTRATION: Phase A - Current Controlled Trials ISRCTN06792113; Phase B - Current Controlled Trials ISRCTN49328913. 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. 23, No. 39. See the NIHR Journals Library website for further project information. Funding was also provided by the Medical Research Council ConDuCT-II Hub (reference number MR/K025643/1).

Wound infections are common after surgery. Some are cured with simple treatment, but others may lead to serious problems. Reducing the risk of a wound infection is important. We do not know if the type of dressing, or not using a dressing, influences the risk of infection. A study that allocated patients to receive different dressings (or no dressing) would answer this question. We did preliminary research to explore whether or not such a study is possible. We interviewed doctors, nurses and patients about their views on dressings and a future study. We also described dressings currently being used in the NHS and found that simple dressings and tissue adhesive (glue) 'as-a-dressing' are used most frequently. We studied existing evidence and interviewed experts to develop a questionnaire, completed by patients, to identify wound infections after patients leave hospital and tested its accuracy. We also explored taking photographs of wounds. We investigated whether or not a major study would be worth the cost and designed a pilot study to test its feasibility. The pilot study recruited 394 patients undergoing abdominal operations in five NHS hospitals. These patients were allocated to have a simple dressing, glue-as-a-dressing or no dressing, and 92% received the allocated dressing method. Patients and their doctors and nurses found the dressing methods to be acceptable. We showed that the new patient questionnaire accurately identified infections. Patients or their carers also found it acceptable to photograph their wounds. Our research suggests that a future large study would be worth the investment and is possible.

Negative pressure wound therapy for surgical wounds healing by primary closure.

BACKGROUND: Indications for the use of negative pressure wound therapy (NPWT) are broad and include prophylaxis for surgical site infections (SSIs). While existing evidence for the effectiveness of NPWT remains uncertain, new trials necessitated an updated review of the evidence for the effects of NPWT on postoperative wounds healing by primary closure. OBJECTIVES: To assess the effects of negative pressure wound therapy for preventing surgical site infection in wounds healing through primary closure. SEARCH METHODS: We searched the Cochrane Wounds Specialised Register, CENTRAL, Ovid MEDLINE (including In-Process & Other Non-Indexed Citations), Ovid Embase, and EBSCO CINAHL Plus in February 2018. We also searched clinical trials 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 on language, publication date, or setting. 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. DATA COLLECTION AND ANALYSIS: Four review authors independently assessed trials using predetermined inclusion criteria. We carried out data extraction, 'Risk of bias' assessment using the Cochrane 'Risk of bias' tool, and quality assessment according to GRADE methodology. MAIN RESULTS: In this second update we added 25 intervention trials, resulting in a total of 30 intervention trials (2957 participants), and two economic studies nested in trials. Surgeries included abdominal and colorectal (n = 5); caesarean section (n = 5); knee or hip arthroplasties (n = 5); groin surgery (n = 5); fractures (n = 5); laparotomy (n = 1); vascular surgery (n = 1); sternotomy (n = 1); breast reduction mammoplasty (n = 1); and mixed (n = 1). In three key domains four studies were at low risk of bias; six studies were at high risk of bias; and 20 studies were at unclear risk of bias. We judged the evidence to be of low or very low certainty for all outcomes, downgrading the level of the evidence on the basis of risk of bias and imprecision.Primary outcomesThree studies reported mortality (416 participants; follow-up 30 to 90 days or unspecified). It is uncertain whether NPWT has an impact on risk of death compared with standard dressings (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.25 to 1.56; very low-certainty evidence, downgraded once for serious risk of bias and twice for very serious imprecision).Twenty-five studies reported on SSI. The evidence from 23 studies (2533 participants; 2547 wounds; follow-up 30 days to 12 months or unspecified) showed that NPWT may reduce the rate of SSIs (RR 0.67, 95% CI 0.53 to 0.85; low-certainty evidence, downgraded twice for very serious risk of bias).Fourteen studies reported dehiscence. We combined results from 12 studies (1507 wounds; 1475 participants; follow-up 30 days to an average of 113 days or unspecified) that compared NPWT with standard dressings. It is uncertain whether NPWT reduces the risk of wound dehiscence compared with standard dressings (RR 0.80, 95% CI 0.55 to 1.18; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision).Secondary outcomesWe are uncertain whether NPWT increases or decreases reoperation rates when compared with a standard dressing (RR 1.09, 95% CI 0.73 to 1.63; 6 trials; 1021 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision) or if there is any clinical benefit associated with NPWT for reducing wound-related readmission to hospital within 30 days (RR 0.86, 95% CI 0.47 to 1.57; 7 studies; 1271 participants; very low-certainty evidence, downgraded for very serious risk of bias and serious imprecision). It is also uncertain whether NPWT reduces incidence of seroma compared with standard dressings (RR 0.67, 95% CI 0.45 to 1.00; 6 studies; 568 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and once for serious imprecision). It is uncertain if NPWT reduces or increases the risk of haematoma when compared with a standard dressing (RR 1.05, 95% CI 0.32 to 3.42; 6 trials; 831 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision. It is uncertain if there is a higher risk of developing blisters when NPWT is compared with a standard dressing (RR 6.64, 95% CI 3.16 to 13.95; 6 studies; 597 participants; very low-certainty evidence, downgraded twice for very serious risk of bias and twice for very serious imprecision).Quality of life was not reported separately by group but was used in two economic evaluations to calculate quality-adjusted life years (QALYs). There was no clear difference in incremental QALYs for NPWT relative to standard dressing when results from the two trials were combined (mean difference 0.00, 95% CI -0.00 to 0.00; moderate-certainty evidence).One trial concluded that NPWT may be more cost-effective than standard care, estimating an incremental cost-effectiveness ratio (ICER) value of GBP 20.65 per QALY gained. A second cost-effectiveness study estimated that when compared with standard dressings NPWT was cost saving and improved QALYs. We rated the overall quality of the reports as very good; we did not grade the evidence beyond this as it was based on modelling assumptions. AUTHORS' CONCLUSIONS: Despite the addition of 25 trials, results are consistent with our earlier review, with the evidence judged to be of low or very low certainty for all outcomes. Consequently, uncertainty remains about whether NPWT compared with a standard dressing reduces or increases the incidence of important outcomes such as mortality, dehiscence, seroma, or if it increases costs. Given the cost and widespread use of NPWT for SSI prophylaxis, there is an urgent need for larger, well-designed and well-conducted trials to evaluate the effects of newer NPWT products designed for use on clean, closed surgical incisions. Such trials should initially focus on wounds that may be difficult to heal, such as sternal wounds or incisions on obese patients.

Preventing pressure ulcers in nursing homes using a care bundle: A feasibility study.

Pressure ulcers can be painful and negatively affect health-related quality of life and healthcare costs. Many people living in nursing homes are at risk of developing a pressure ulcer. Nursing home staff, tissue viability nurses and researchers have co-designed the first theory and evidence-informed care bundle specifically for nursing homes, which consists of three prevention practices (skin inspection, support surfaces, repositioning) and a range of behaviour change techniques to promote these practices. We conducted a mixed methods feasibility study of the use of this care bundle in one nursing home in the North of England using an uncontrolled, before-and-after study design. We collected quantitative data on pressure ulcer prevention behaviours of the nursing home staff and pressure ulcer incidence rates for 5 weeks prior to implementing the bundle. Data collection continued for a further 9 weeks during the bundle implementation phase. We explored adherence to the bundle and participants' experiences of using it. The Conceptual Framework for Implementation Fidelity and the Theoretical Domains Framework informed the semi-structured interviews. Quantitative and qualitative data were analysed using descriptive statistics and deductive framework analysis respectively. We collected data for 462 resident bed days prior to implementing the bundle; five new pressure ulcers were recorded and repositioning was the only documented pressure ulcer prevention behaviour. We collected data for 1,181 resident bed days during the intervention phase; no new pressure ulcers developed and the documented prevention behaviours included repositioning, skin inspection and checking support surfaces. Participants reported that the bundle enhanced the care they delivered and offered suggestions for future improvements. Our findings have highlighted a number of feasibility issues surrounding recruitment and retention, collecting data and implementation fidelity. A pressure ulcer prevention bundle specifically designed for nursing homes was acceptable. The feasibility work has highlighted the potential for the intervention and the areas that require development and refinement.

Evaluating the development and validation of empirically-derived prognostic models for pressure ulcer risk assessment: A systematic review.

BACKGROUND: Researchers advocate developing empirically-derived prognostic models to predict pressure ulcer risk. However, there remains a scarcity of evidence about the performance and clinical value of these models. OBJECTIVES: To identify and describe empirically-derived models for predicting pressure ulcer risk; to assess the predictive performance of these models; and to evaluate their clinical impact in reducing pressure ulcer incidence. METHODS: We performed a comprehensive database search up to February 2017 and searched other resources to identify longitudinal studies that developed and/or validated prognostic models for predicting pressure ulcer risk and studies evaluating the clinical effects of such models. There were no language or publication date restrictions. Two reviewers independently conducted study selection. Using a pre-prepared data extraction form, one reviewer collected data on the characteristics and performance of the included models and assessed study risk of bias. A second reviewer checked all the data. Using narrative synthesis, we summarised the characteristics of the included studies and models. Using meta-analysis, we combined performance (discrimination and calibration) measurement statistics for relevant models. RESULTS: We included 24 studies with 28 data sources in the review and identified 22 models that were developed using these data. Of the 22 models, only seven had further external validations (one model was validated twice). In development, a third of models used univariate analysis alone to identify statistically significant predictors for subsequent multivariable analysis; and nine of the 16 developed models were formed using stepwise selection processes in multivariable analysis. Missing data were often incompletely reported, and continuous predictors were correctly handled in only two models (e.g., using restricted cubic spline). Sample sizes of the model development studies were small with 13 models involving fewer than 10 events per variable. The risk of bias associated with the development of all 22 models and eight validations was judged as high or unclear. The predictive performance was reported as: c-statistic point estimates ranging from 0.65 to 0.89, and total Observed:Expected risk ratios between 0.94 and 1.00. Compared with heuristic tools, relevant included models had better discrimination and calibration. No eligible study was identified that evaluated the clinical impact of any included model. CONCLUSIONS: Whilst many prognostic models for predicting ulcer risk have been developed few have been validated. The methods used for model development are generally flawed which reduces the potential for using these models in practice. Future research should address these weaknesses.

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.

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.

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial.

BACKGROUND: Surgical site infections (SSIs) are common, occurring in up to 25% of > 4 million operations performed in England each year. Previous trials of the effect of wound dressings on the risk of developing a SSI are of poor quality and underpowered. METHODS/DESIGN: This study is a feasibility and pilot trial to examine the feasibility of a full trial that will compare simple dressings, no dressing and tissue-glue as a dressing. It is examining the overall acceptability of trial participation, identifying opportunities for refinement, testing the feasibility of and validating new outcome tools to assess SSI, wound management issues and patients' wound symptom experiences. It is also exploring methods for avoiding performance bias and blinding outcome assessors by testing the feasibility of collecting wound photographs taken in theatre immediately after wound closure and, at 4-8 weeks after surgery, taken by participants themselves or their carers. Finally, it is identifying the main cost drivers for an economic evaluation of dressing types. Integrated qualitative research is exploring acceptability and reasons for non-adherence to allocation. Adults undergoing primary elective or unplanned abdominal general surgery or Caesarean section are eligible. The main exclusion criteria are abdominal or other major surgery less than three months before the index operation or contraindication to dressing allocation. The trial is scheduled to recruit for nine months. The findings will be used to inform the design of a main trial. DISCUSSION: This pilot trial is the first pragmatic study to randomise participants to no dressing or tissue-glue as a dressing versus a simple dressing. Early evidence from the ongoing pilot shows that recruitment is proceeding well and that the interventions are acceptable to participants. Combined with the qualitative findings, the findings will inform whether a main, large trial is feasible and, if so, how it should be designed. TRIAL REGISTRATION: ISRCTN49328913 . Registered on 20 October 2015.

Reconstructive surgery for treating pressure ulcers.

BACKGROUND: The management of pressure ulcers involves several interventions ranging from pressure-relieving measures such as repositioning, to treatments that can include reconstructive surgery. Such surgery may be considered for recalcitrant wounds when full thickness skin loss arises and deeper structures such as muscle fascia and even bone are exposed. The surgery commonly involves wound debridement followed by the addition of new tissue into the wound. Whilst reconstructive surgery is an accepted means of ulcer management, the benefits and harms of surgery compared with non-surgical treatments, or alternative surgical approaches are not clear. OBJECTIVES: To assess the effects of reconstructive surgery for healing pressure ulcers (stage II or above), comparing surgery with no surgery or comparing alternative forms of surgery in any care setting. SEARCH METHODS: We searched the following electronic databases to identify reports of relevant randomised clinical trials (searched 26 September 2016): the Cochrane Wounds Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL. We also searched three clinical trials registers and reference lists of relevant systematic reviews, meta-analyses and health technology assessment reports. SELECTION CRITERIA: Published or unpublished randomised controlled trials that assessed reconstructive surgery in the treatment of pressure ulcers. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection. We planned that two review authors would also assess the risk of bias and extract study data. MAIN RESULTS: We did not identify any studies that met the review eligibility criteria nor any registered studies investigating the role of reconstructive surgery in the management of pressure ulcers. AUTHORS' CONCLUSIONS: Currently there is no randomised evidence that supports or refutes the role of reconstructive surgery in pressure ulcer management. This is a priority area and there is a need to explore this intervention with more rigorous and robust research.

The use of unequal randomisation in clinical trials--An update.

OBJECTIVE: To update a 2005 review of the reasons researchers have given for the use of unequal randomisation in randomised controlled trials (RCTs). MAIN MEASURES: Intervention being tested; type of study; number of participants; randomisation ratio; sample size calculation and reason given for using unequal randomisation. METHODS: Review of trials using unequal randomisation. DATABASES AND SOURCES: Cochrane library, Medline and CINAHL. RESULTS: A total of 86 trials were identified. Of these 82 trials (95%) recruited patients in favour of the experimental group. Various reasons for the use of unequal randomisation were given including: gaining treatment experience; identification of adverse events; ethical; logistic and enhancing recruitment. No trial reported explicitly used it for cost-effectiveness. Most of the papers (i.e. 47, 55%) did not state why they had used unequal randomisation and only 38 trials (44%) appeared to have taken the unequal randomisation into account in their sample size calculation. CONCLUSION: Most studies did not mention the rationale for unequal allocation, and a significant proportion did not appear to account for it in the sample size calculations. Unlike the previous review economic considerations were not stated as a rationale for its use. A number of trials used it to enhance recruitment, although this has not been tested.

VenUS IV (Venous leg Ulcer Study IV) - compression hosiery compared with compression bandaging in the treatment of venous leg ulcers: a randomised controlled trial, mixed-treatment comparison and decision-analytic model.

BACKGROUND: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB. OBJECTIVES: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers. DESIGN: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model. SETTINGS: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland. PARTICIPANTS: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression. INTERVENTIONS: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB). MAIN OUTCOME MEASURES: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs. RESULTS: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers. CONCLUSIONS: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49373072. 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. 18, No. 57. See the NIHR Journals Library website for further project information.

Point prevalence of complex wounds in a defined United Kingdom population.

Complex wounds (superficial-, partial-, or full-thickness skin loss wounds healing by secondary intention) are common; however, there is a lack of high-quality, contemporary epidemiological data. This paper presents point prevalence estimates for complex wounds overall as well as for individual types. A multiservice, cross-sectional survey was undertaken across a United Kingdom city (Leeds, population 751,485) during 2 weeks in spring of 2011. The mean age of people with complex wounds was approximately 70 years, standard deviation 19.41. The point prevalence of complex wounds was 1.47 per 1,000 of the population, 95% confidence interval 1.38 to 1.56. While pressure ulcers and leg ulcers were the most frequent, one in five people in the sample population had a less common wound type. Surveys confined to people with specific types of wound would underestimate the overall impact of complex wounds on the population and health care resources.

Dressings for the prevention of surgical site infection.

BACKGROUND: Surgical wounds (incisions) heal by primary intention when the wound edges are brought together and secured - often with sutures, staples, clips or glue. Wound dressings, usually applied after wound closure, provide physical support, protection from bacterial contamination and absorb exudate. Surgical site infection (SSI) is a common complication of surgical wounds that may delay healing. OBJECTIVES: To assess the effects of wound dressings for preventing SSI in people with surgical wounds healing by primary intention. SEARCH METHODS: In February 2014 we searched: The Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); The Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library); The Health Technology Assessment Database (HTA) (The Cochrane Library); NHS Economic Evaluation Database (NHSEED) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. There were no restrictions based on language or date of publication or study setting. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing alternative wound dressings or wound dressing with no dressing (wound exposure) for the postoperative management of surgical wounds healing by primary intention. DATA COLLECTION AND ANALYSIS: Two review authors performed study selection, risk of bias assessment and data extraction independently. MAIN RESULTS: Twenty RCTs were included (3623 participants). All trials were at unclear or high risk of bias. Twelve trials included people with wounds resulting from surgical procedures with a contamination classification of 'clean', two trials included people with wounds resulting from surgical procedures with a 'clean/contaminated' contamination classification and the remaining trials evaluated people with wounds resulting from various surgical procedures with different contamination classifications. Two trials compared wound dressings with leaving wounds exposed. The remaining 18 trials compared two alternative dressing types. No evidence was identified to suggest that any dressing significantly reduced the risk of developing an SSI compared with leaving wounds exposed or compared with alternative dressings in people who had surgical wounds healing by primary intention. AUTHORS' CONCLUSIONS: At present, there is insufficient evidence as to whether covering surgical wounds healing by primary intention with wound dressings reduces the risk of SSI or whether any particular wound dressing is more effective than others in reducing the rates of SSI, improving scarring, pain control, patient acceptability or ease of dressing removal. Most trials in this review were small and at high or unclear risk of bias. However, based on the current evidence, we conclude that decisions on wound dressing should be based on dressing costs and the symptom management properties offered by each dressing type e.g. exudate management.