Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial

This study evaluates whether applying RECELL® autologous skin cell suspension (ASCS) to one half of a split-thickness skin graft (STSG) donor site accelerates re-epithelialization and improves long-term scar quality compared with the untreated half of the same donor site. Using a prospective, randomized, intra-patient (split-site) controlled design, each participant's donor site is divided into two contiguous, comparable halves at the time of surgery; one half is randomized to receive RECELL® application plus standard transparent film dressing, while the other receives standard dressing alone. Each participant serves as their own control, eliminating inter-patient variability in healing. Participants are followed for 12 months with serial standardized digital photography, blinded outcome assessment, and validated scar-assessment instruments (POSAS 2.0, Vancouver Scar Scale).

Inclusion Criteria: * Age 18 years or older at time of consent * Scheduled to undergo split-thickness skin graft (STSG) harvest for any surgical indication (burn, trauma, oncologic reconstruction, chronic wound, or other) * Able and willing to provide informed consent and comply with follow-up visits through 12 months * Donor site anatomically able to be divided into two contiguous, comparable halves (e.g., anterolateral thigh) * Willing to undergo standardized photographic documentation of the donor site Exclusion Criteria: * Donor site area insufficient to divide into two comparable, independently assessable halves (less than 20 cm² total) * Known hypersensitivity to trypsin, or bovine or porcine-derived products used in RECELL® processing per device Instructions for Use * Active infection, surgical incision, or trauma at the planned donor site * Pregnancy * Non-English-speaking patients * Prisoners, cognitively impaired adults unable to consent, children, neonates, or other vulnerable populations as defined by the UC Davis IRB