Utility of RECELL for Traumatic Skin Defects: Protocol for a Prospective, Single-Arm Pilot Study

Skin grafting is currently the gold standard for managing traumatic skin defects. However, split-thickness skin grafting, the most common technique, is challenging because it yields a limited amount of skin and creates a new wound at the healthy donor site. RECELL (Avita Medical), a noncultured skin cell suspension technique, yields healing outcomes with comparable duration and quality to skin grafting for burn trauma. Although RECELL is widely used for burn trauma, its use for severe traumatic skin defects is not yet prevalent in Japan.

This study aims to evaluate the utility of the RECELL skin reconstruction technique in trauma cases involving significant skin defects. Specifically, the primary aim is to validate the efficacy of the RECELL skin reconstruction technique when combined with split-thickness mesh grafting in patients with significant posttraumatic skin defects, with a particular focus on wound closure and scar quality.

This prospective, single-center, open-label pilot study will enroll patients aged 16 years and older with traumatic limb skin defects ≥160 cm² and sufficient dermal-like tissue. Participants will undergo RECELL-assisted autologous skin grafting with mesh grafts under general anesthesia. Wound healing, scarring (Vancouver Scar Scale), and pain (visual analog scale) will be assessed up to 24 weeks postoperatively. The primary end point is ≥95% reepithelialization at postoperative day 14. Descriptive statistical analyses will be performed to evaluate outcomes and inform future randomized trials.

Patient recruitment began in April 2024 and is currently ongoing in our hospital. As of April 10, 2025, 10 patients had been screened, of whom 4 were enrolled. No adverse events or protocol deviations have been noted.

This study aims to validate the utility of RECELL for skin defects resulting from trauma by assessing wound closure and scar formation, including adverse events, delayed healing, infection, and durability.