JMIR Publications

ABSTRACT

Background RECELL® (Avita Medical, Cambridge, UK), a non-cultured skin cell suspension technique, provides results comparable with skin grafting in terms of duration and healing quality. However, in Japan, the clinical use of RECELL® for burn trauma has become possible but not for skin defects associated with trauma. Reports using RECELL® with split-thickness skin grafting for burn trauma showed good results. The purpose of this study is to evaluate the utility of the RECELL® skin reconstruction technique in trauma cases with significant skin defects. Methods This is a single-center, open-label, uncontrolled, single-arm comparative prospective study. The inclusion criteria are age ≥ 16 years with skin defects ≥ 160 cm2 due to trauma (excluding the hands and face and burn trauma) or skin defects due to skin flaps. The test site should exhibit sufficient dermal-like tissue formation. Under general anesthesia, skin grafts will be harvested from healthy skin donor sites (groin, thigh, or scalp). In addition to RECELL® skin grafts, the necessary amount of mesh skin grafts will be collected. A mesh graft will be applied to the defect where the graft is to be placed, and the non-cultured cell suspension previously prepared using the RECELL® technique will be sprayed onto the mesh grafted area. A non-adherent gauze will be applied to the skin graft, and the gauze will be placed over the gauze for bandage fixation. The primary endpoints are healing of the recipient and donor sites. The secondary endpoints are scar assessment using the Vancouver Scar Scale, pigmentation, vascularity, pliability, and contracture. The observation period will be 24 weeks after surgery. Discussion We intend to validate the utility of RECELL® for skin defects due to trauma by observing wound closure, scar formation including its adverse events, delayed healing, infection, and its durability.