Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) Cohort: Feasibility data from a multi-centre prospective observational cohort study to inform a future Randomised Controlled Trial (RCT)

Abstract

Background: Compression therapy is considered beneficial for lower limb post-surgical wounds healing by secondary intention, however there is a lack of supportive evidence. To plan a randomised controlled trial suitable data is needed. Objectives: Determine feasibility of recruitment and estimate recruitment rate Understand the standard post-operative wound management pathway Determine uptake of optional additional clinic visit for healing confirmation Explore patient acceptability of compression bandaging and a future RCT METHODS: Participant recruitment over 22 months from secondary care Dermatology clinics. Eligibility criteria: INCLUSION: over 18 years; planned excision of keratinocyte cancer on lower leg with healing by secondary intention; ankle-brachial pressure index ≥ 0.8 EXCLUSION: planned primary closure/graft or flap; unable to receive/comply/tolerate high compression; planned compression; suspected melanoma Followed up weekly (maximum 6 months) in secondary care clinics and/or by telephone. Information collected on healthcare resource use, unplanned compression, wound healing, optional clinic visit to confirm healing. Results: 58 patients recruited from 9 secondary care dermatology clinics in 22 months. Mean recruitment/centre/month was 0.8 (range 0.1-2.3). Four centres had dedicated Research Nurse support. The analysis population (n=53) attended weekly follow-up assessments. Standard care clinical contacts were: GP visits 7(1.2%), Community Nurse visits 169(28.5%), Practice nurse visits 189(31.8%), and Dermatology clinic visits 138(23.2%). Participants whose wounds healed, 34/45(75.6%) attended an optional clinic visit. Conclusions: Data were obtained to inform a future RCT. Recruitment rates are higher in centres with dedicated research support. People would be willing to take part in a trial and attend a confirmation of healing visit.