Autologous skin substitute for hard‐to‐heal ulcers: Retrospective analysis on safety, applicability, and efficacy in an outpatient and hospitalized setting

Abstract

Abstract Chronic ulcers ((arterio)venous, decubitus, or postoperative) have no tendency to heal within a period of at least 3 months despite optimal therapy according to internationally accepted guidelines. This retrospective study evaluates the safety and efficacy of an autologous, dermal‐epidermal skin substitute (SS) for treating ulcers of various origins. Ulcers were treated within 7 D utch centers over 5 years. Sixty‐six ulcers (size: 0.75–150 cm 2 ; duration: 0.25–32 years) with a follow‐up time of 24 weeks after a single‐skin substitute application were assessed. Wound‐bed preparation consisted of vacuum‐assisted‐closure‐therapy (5 days, hospitalized) or application of acellular dermis (5–7 days, outpatient). Time to heal, adverse events, and recurrence 1 year after complete healing were recorded. Complete ulcer healing occurred in 36 of 66 ulcers (55%) at 24 weeks. At that time point, a further 29% of ulcers showed decrease in ulcer size between 50 and 99%. No difference was observed between the hospitalized vs. outpatient treatment with complete healing. There were 32 of 36 healed ulcers that were available for follow‐up 1 year after complete closure, of which 27 (84%) were still closed. Only two minor/moderate possibly related adverse events were recorded. This retrospective analysis shows that SS provides a safe and successful treatment for particularly chronic ulcers of various origins.