Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) cohort study. Part 1: a multicentre prospective observational cohort study in patients without planned compression

Abstract

Background. There is no agreed treatment pathway following excision of keratinocyte cancer (KC). Compression therapy is considered beneficial for secondary intention healing on the lower leg; however, there is a lack of supportive evidence. To plan a randomized controlled trial (RCT), suitable data are needed. We report a multicentre prospective observational cohort study in this patient population with the intention of informing a future trial design. Aim. To estimate the time to healing in wounds healing by secondary intention without planned postoperative compression, following excision of KC on the lower leg; to characterize the patient population, including factors affecting healing; and to assess the incidence of complications. Methods. This was a multicentre prospective observational cohort study. Inclusion criteria were age ≥ 18 years with planned excision of KC on the lower leg and healing by secondary intention, an ankle-brachial pressure index (ABPI) of ≥ 0.8; and written informed consent. Exclusion criteria included planned excision with primary closure, skin graft or flap; compression therapy for another indication; planned compression; inability of patient to receive, comply with or tolerate high compression; or a suspected diagnosis other than KC.Results. This study recruited 58 patients from 9 secondary care dermatology clinics. In the analysis population (n = 53), mean age was 81 years (range 25-97 years), median time to healing was 81 days (95% CI 73-92) and 45 patients (84.9%) had healing of the wound at the 6-month follow-up. The healing prognostic factors were wound parameters and ABPI. Wound infections occurred in 16 participants (30.2%). Four patients (7.5%) were admitted to hospital; three because of an infection and one because of a fall.

Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) cohort study. Part 2: feasibility data from a multicentre prospective observational cohort study to inform a future randomized controlled trial

“…This study has highlighted important factors to consider in the design of a future RCT alongside the important clinical data we have reported in this patient group 5 . Recruitment to trials is challenging, 12 and realistic recruitment predictions are a key consideration at the grant‐application stage to ensure a trial is achievable within its proposed timeframes and associated funding.…”

“…This study has highlighted important factors to consider in the design of a future RCT alongside the important clinical data we have reported in this patient group. 5 Recruitment to trials is challenging, 12 and realistic recruitment predictions are a key consideration at the grant‐application stage to ensure a trial is achievable within its proposed timeframes and associated funding. Recruitment predictions should take account of participating centres and their research infrastructure, and robust centre feasibility assessments will inform prioritization of centres to open to recruitment.…”

“…When a wound was reported as healed, the participant was invited to attend the secondary care clinic for a confirmatory healing assessment. The variables collected are detailed in the previous publication, 5 and with additional data collected for this study on screening, patient pathway details [including which healthcare professional (HCP), or the participant themselves] treated the wound, where the patient was seen and whether they attended the optional wound‐healing‐confirmation visit.…”

“…Clinical healing and safety data of the Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) cohort study have already been reported 5 . This paper reports on the additional aims of understanding the feasibility of recruitment, the patient pathway and patient acceptability of the interventions in preparation for a large‐scale definitive Phase 3 trial.…”

“… 2 It is likely that secondary intention surgical wounds on the lower leg may also benefit from compression. Compression therapy following dermatological surgery on the lower legs is often practised, 4 , 5 with the intention of improving wound healing, but without strong supporting evidence. A randomized controlled trial (RCT) would confirm whether standard wound care with compression therapy is more effective than standard wound care alone.…”