Open AccessWound 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
Author(s) -
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
Publication year - 2022
Publication title -
international wound journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.867
H-Index - 63
eISSN - 1742-481X
pISSN - 1742-4801
DOI - 10.1111/iwj.13646
Subject(s) - medicine , diabetic foot , surgery , interquartile range , skin grafting , wound care , foot (prosody) , randomized controlled trial , wound healing , diabetes mellitus , clinical trial , body mass index , linguistics , philosophy , endocrinology
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 cm 2 ), 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) cm 2 . 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).