Pragmatic randomised controlled trial to evaluate the clinical and cost-effectiveness of compression therapy for surgical wounds healing by secondary intention following excision of lower limb keratinocyte cancers in UK skin cancer surgery centres (HEALS2 trial): study protocol

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INTRODUCTION: Keratinocyte cancers (KCs) are increasing in incidence in the UK, with over 234 000 cases annually, largely due to demographic changes and sun exposure. Skin cancers, including malignant melanoma and KCs, are projected to cost the NHS over £180 million annually and impose healthcare demands. Although KCs have high cure rates following surgical excision and primary closure, wounds healing by secondary intention (HBSI) particularly on the lower leg present clinical challenges. Compression therapy (CT) known to improve venous insufficiency and venous ulcer healing may also benefit HBSI following lower limb KC excision but current evidence is sparse. METHODS AND ANALYSIS: econdary intention (HEALS2) is a multicentre, prospective, Phase III, parallel group, open-label, randomised controlled trial with embedded internal pilot and blinded endpoint assessment. A total of 396 participants (≥18 years) from UK skin cancer surgery centres will be randomised 1:1 to assess the clinical and cost-effectiveness of standard care (SC) alone or with CT (SC+CT) for surgical wounds HBSI following excision of lower limb KCs.The primary outcome is time to healing from randomisation (maximum 52-week follow-up). Secondary outcomes include incidence of infection, antibiotic usage, scar quality, safety (including complications and hospitalisations), quality of life, cost-effectiveness and relationship between post-partial closure wound area, type of partial closure method and time to healing. Exploratory objectives include association between short-term wound area reduction and time to HBSI, patient acceptability, adherence and associations between wound breakdown post-healing and CT use. A qualitative sub-study will explore patients' experiences and decision-making during CT use.Primary endpoint analysis will be conducted on the intention-to-treat population using a multivariable Cox Proportional Hazards modelling. Secondary outcomes and safety will be evaluated using other regression models and descriptive statistics, respectively. Cost-effectiveness will be evaluated using within-trial analysis and decision-analytic modelling. Patient and public involvement representatives are contributing to trial design and oversight. The study protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Yorkshire & The Humber - Leeds East Research Ethics Committee (ref 23/YH/0247). Findings will be published in high-impact peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN12417689.

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