Wound healing with “spray‐on” autologous skin grafting (ReCell) compared with standard care in patients with large diabetes‐related foot wounds: an open‐label randomised controlled trial

• Published in: International wound journal 2022-03, Vol.19 (3), p.470-481
• Main Authors: Manning, Laurens, Ferreira, Ivana Bastos, Gittings, Paul, Hiew, Jonathan, Ryan, Erica, Baba, Mendel, Raby, Edward, Carville, Keryln, Norman, Paul E., Davis, Wendy Angela, Wood, Fiona, Hamilton, Emma Jane, Ritter, Jens Carsten
• Format: Article
• Language: English
• Subjects: Amputation; Ankle; Antibiotics; Australia; Clinical trials; Community nursing; Costs; Debridement; Diabetes; Diabetes Mellitus; diabetic foot; Diabetic Foot - surgery; Foot diseases; Humans; Infections; Leg ulcers; Mortality; Nursing care; Original; Quality of life; skin; Skin & tissue grafts; Skin Transplantation; ulcer; Wound Healing
• ISSN: 1742-4801; 1742-481X
• DOI: 10.1111/iwj.13646

There is an urgent need for interventions that improve healing time, prevent amputations and recurrent ulceration in patients with diabetes‐related foot wounds. In this randomised, open‐label trial, participants were randomised to receive an application of non‐cultured autologous skin cells (“spray‐on” skin; ReCell) or standard care interventions for large (>6 cm2), adequately vascularised wounds. The primary outcome was complete healing at 6 months, determined by assessors blinded to the intervention. Forty‐nine eligible foot wounds in 45 participants were randomised. An evaluable primary outcome was available for all wounds. The median (interquartile range) wound area at baseline was 11.4 (8.8‐17.6) cm2. A total of 32 (65.3%) index wounds were completely healed at 6 months, including 16 of 24 (66.7%) in the spray‐on skin group and 16 of 25 (64.0%) in the standard care group (unadjusted OR [95% CI]: 1.13 (0.35‐3.65), P = .845). Lower body mass index (P = .002) and non‐plantar wounds (P = .009) were the only patient‐ or wound‐related factors associated with complete healing at 6 months. Spray‐on skin resulted in high rates of complete healing at 6 months in patients with large diabetes‐related foot wounds, but was not significantly better than standard care (Australian New Zealand Clinical Trials Registry: ACTRN12618000511235).