• Healing of ExcisionAl wounds on Lower legs by Secondary intention (HEALS) Cohort Study: A multi-centre prospective observational cohort study in patients without planned compression

      Veitch, David
      Background: There is no agreed treatment pathway following excision of keratinocyte cancers. Compression therapy is considered beneficial for secondary intention healing on the lower limb, however there is a lack of supportive evidence. To plan a randomised controlled trial suitable data is needed. This paper reports a multi-centre prospective observational cohort study in this patient population, to inform a future trial design. Objectives: 1. To estimate the time to healing in wounds healing by secondary intention without planned post-operative compression, following excision of keratinocyte cancers on the lower leg 2. To characterise the patient population including factors affecting healing 3. To assess the incidence of complications METHODS: INCLUSION CRITERIA: People over 18 years; planned excision of keratinocyte cancer on lower leg with healing by secondary intention; ankle-brachial pressure index (ABPI) greater than or equal to 0.8; written informed consent EXCLUSION CRITERIA: Planned: primary closure, skin graft or flap; compression therapy for another indication; unable to receive, comply or tolerate high compression; planned compression; suspected diagnosis other than keratinocyte cancer. Results: This study recruited 58 patients from 9 secondary care dermatology clinics. In the analysis population (n=53): mean age was 81 (range 25-97) years; median time to healing was 81(95% Confidence Interval:73-92) days and at 6-month 45 patients (84.9%) had healed. Healing prognostic factors were wound parameters, and ABPI. Wound infections occurred in 16 participants(30.2%) and 4(7.5%) were admitted to hospital. Conclusions: Data collected has informed the RCT preparation. A relatively high (7.5-15%) proportion of wounds not healed, incidence of infection and hospital admissions demonstrated the need for clearly establishing potentially effective treatments and improve outcomes for this population.