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

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 Dutch centers over 5 years. Sixty-six ulcers (size: 0.75-150 cm²; 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.

Differential Response of Human Adipose Tissue-Derived Mesenchymal Stem Cells, Dermal Fibroblasts, and Keratinocytes to Burn Wound Exudates: Potential Role of Skin-Specific Chemokine CCL27

“…This finding is in line with our previous results 32 and indicates that SS are very potent secretors of wound-healing mediators and, therefore, are suitable for healing chronic wounds. 10,41 Incorporation of ASC rather than fibroblasts may increase the potency of SS even further.…”

Comparison of advanced therapy medicinal product gingiva and skin substitutes and their in vitro wound healing potentials

“…We have previously shown that large chronic ulcers (>150 cm 2 ) can successfully be treated with the first generation SS. Oral wounds are generally smaller than skin wounds and therefore will require less biopsies to construct sufficient GS pieces to close the wound (Blok et al, 2013; Gibbs et al, 2006; Vriens et al, 2008). …”

“…Before the implementation of the European ATMP regulations the SS was extensively studied in a phase I clinical trial, with over 100 hard‐to‐heal therapy‐resistant ulcers treated (Blok et al, 2013). The GS was implemented in a proof‐of‐concept pilot study, closing three gingiva lesions (Vriens et al, 2008).…”

Management of mixed arterial venous lower extremity ulceration: A review

“…28 Sheehan and colleagues demonstrated that when biological dressings are used for chronic wounds that have failed to heal at an appropriate rate of closure, a 55% reduction in wound area can be achieved within 4 weeks of treatment. 29 These types of dressings may utilize epidermal or dermal elements.…”