Wounds research for patient benefit: a 5-year programme of research

Background Complex wounds are those that heal by secondary intention and include lower-limb ulcers, pressure ulcers and some surgical wounds. The care of people with complex wounds is costly, with care mainly being delivered by community nurses. There is a lack of current, high-quality data regarding the numbers and types of people affected, care received and outcomes achieved. Objectives To (1) assess how high-quality data about complex wounds can be captured effectively for use in both service planning and research while ensuring integration with current clinical data collection systems and minimal impact on staff time; (2) investigate whether or not a clinical register of people with complex wounds could give valid estimates of treatment effects, thus reducing dependence on large-scale randomised controlled trials (RCTs); (3) identify the most important research questions and outcomes for people with complex wounds from the perspectives of patients, carers and health-care professionals; (4) evaluate the potential contributions to decision-making of individual patient data meta-analysis and mixed treatment comparison meta-analysis; and (5) complete and update systematic reviews in topic areas of high priority. Methods To meet objectives 1 and 2 we conducted a prevalence survey and developed and piloted a longitudinal disease register. A consultative, deliberative method and in-depth interviews were undertaken to address objective 3. To address objectives 4 and 5 we conducted systematic reviews including mixed treatment comparison meta-analysis. Results From the prevalence survey we estimated the point prevalence of all complex wounds to be 1.47 per 1000 people (95% confidence interval 1.38 to 1.56 per 1000 people). Pressure ulcers and venous leg ulcers were the most common type of complex wound. A total of 195 people with a complex wound were recruited to a complex wounds register pilot. We established the feasibility of correctly identifying, extracting and transferring routine NHS data into the register; however, participant recruitment, data collection and tracking individual wounds in people with multiple wounds were challenging. Most patients and health professionals regarded healing of the wound as the primary treatment goal. Patients were greatly troubled by the social consequences of having a complex wound. Complex wounds are frequently a consequence of, and are themselves, a long-term condition but treatment is usually focused on healing the wound. Consultative, deliberative research agenda setting on pressure ulcer prevention and treatment with patients, carers and clinicians yielded 960 treatment uncertainties and a top 12 list of research priorities. Of 167 RCTs of complex wound treatments in a systematic review of study quality, 41% did not specify a primary outcome and the overall quality of the conduct and reporting of the research was poor. Mixed-treatment comparison meta-analysis in areas of high priority identified that matrix hydrocolloid dressings had the highest probability (70%) of being the most effective dressing for diabetic foot ulcers, whereas a hyaluronan fleece dressing had the highest probability (35%) of being the most effective dressing for venous ulcers; however, the quality of this evidence was low and uncertainty is high. Conclusions Complex wounds are common and costly with a poor evidence base for many frequent clinical decisions. There is little routine clinical data collection in community nursing. A prospective complex wounds register has the potential to both assist clinical decision-making and provide important research evidence but would be challenging to implement without investment in information technology in NHS community services. Future work should focus on developing insights into typical wound healing trajectories, identifying factors that are prognostic for healing and assessing the cost-effectiveness of selected wound treatments. Funding The National Institute for Health Research Programme Grants for Applied Research programme

Pilot feasibility randomized clinical trial of negative-pressure wound therapy versus usual care in patients with surgical wounds healing by secondary intention

Background Surgical wounds healing by secondary intention (SWHSI) are increasingly being treated with negative‐pressure wound therapy (NPWT) despite a lack of high‐quality research evidence regarding its clinical and cost‐effectiveness. This pilot feasibility RCT aimed to assess the methods for and feasibility of conducting a future definitive RCT of NPWT for the treatment of SWHSI. Methods Eligible consenting adult patients receiving care at the study sites (2 acute and 1 community) and with a SWHSI appropriate for NPWT or wound dressing treatment were randomized 1 : 1 centrally to receive NPWT or usual care (no NPWT). Participants were followed up every 1–2 weeks for 3 months. Feasibility (recruitment rate, time to intervention delivery) and clinical (time to wound healing) outcomes were assessed. Results A total of 248 participants were screened for eligibility; 40 (16·1 per cent) were randomized, 19 to NPWT and 21 to usual care. Twenty‐four of the 40 wounds were located on the foot. Participants received NPWT for a median of 18 (range 0–72) days. Two participants in the NPWT group never received the intervention and 14 received NPWT within 48 h of randomization. Five participants in the usual care group received NPWT during the study. Ten of the 40 wounds were deemed to have healed during the study. Conclusion A full‐scale RCT to investigate the clinical and cost‐effectiveness of NPWT for SWHSI is feasible. This study identified crucial information on recruitment rates and data collection methods to consider during the design of a definitive RCT. Registration number: ISRCTN12761776 (www.iscrtn.com

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6) : study protocol for a pragmatic, multicentre, parallel group, three arm randomised controlled trial

Background Venous leg ulcer(s), are common, recurring, open wounds on the lower leg, resulting from diseased or damaged leg veins impairing blood flow. Wound healing is the primary treatment aim for venous leg ulceration, alongside management of pain, wound exudate and infection. Full (high) compression therapy delivering 40mmHg of pressure at the ankle is the recommended first line treatment for venous leg ulcers. There are several different forms of compression therapy available including wraps, two-layer hosiery, and two-layer or four-layer bandages. There is good evidence for the clinical and cost effectiveness of four-layer bandage and two-layer hosiery but more limited evidence for other treatments (two-layer bandage and compression wraps). Robust evidence is required to compare clinical and cost effectiveness of these and to investigate which is the best compression treatment for reducing time to healing of venous leg ulcers whilst offering value for money. VenUS 6 will therefore investigate the clinical and cost effectiveness of evidence-based compression, two-layer bandage and compression wraps for time to healing of venous leg ulcers. Methods VenUS 6 is a pragmatic, multi-centre, three arm, parallel group, randomised controlled trial. Adult patients with a venous leg ulcer will be randomised to receive 1) compression wraps, 2) two-layer bandage or 3) evidence-based compression (two-layer hosiery or four-layer bandage). Participants will followed up for between 4 and 12 months. The primary outcome will be time to healing (full epithelial cover in absence of a scab) in days since randomisation. Secondary outcomes will include key clinical events (e.g., healing of the reference leg; ulcer recurrence; ulcer/skin deterioration, amputation, admission/discharge, surgery to close/remove incompetent superficial veins, infection, or death), treatment changes, adherence and ease of use, ulcer related pain, health-related quality of life and resource use. Discussion VenUS 6 will provide robust evidence on the clinical and cost-effectiveness of the different forms of compression therapies for venous leg ulceration. VenUS 6 opened to recruitment in January 2021 and is currently recruiting across 30 participating centres. Clinical Trial Registry: ISRCTN 67321719 (https://doi.org/10.1186/ISRCTN67321719). Prospectively Registered: 14.09.202