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).

Split-thickness skin graft (STSG) donor-site morbidity-defined as pain, prolonged healing, dyspigmentation, and hypertrophic scarring-remains a persistent source of patient dissatisfaction and, in a minority of cases, a site more symptomatic than the original wound. Standard donor-site management at UC Davis uses an absorptive/antimicrobial dressing (Telfa or Mepilex Ag) left undisturbed for approximately five days to support re-epithelialization from residual dermal appendages.

RECELL® is an FDA-approved point-of-care device (PMA BP170122) that processes a small split-thickness skin sample into a non-cultured ASCS containing keratinocytes, melanocytes, and fibroblasts, which is sprayed directly onto the wound bed to seed re-epithelialization. RECELL® is currently approved for acute thermal burns (2018), full-thickness skin defects from surgical excision or traumatic avulsion (2023), and repigmentation of stable vitiligo (2021). Its labeled indications do not include STSG donor sites specifically, which are partial-thickness, iatrogenic wounds.

A published randomized controlled trial (Hu et al., BJS 2017; n=106) found median time to complete re-epithelialization of 9.0 days (95% CI 8.3-9.7) with ASCS versus 13.0 days (95% CI 12.4-13.6) with control (p less than 0.001), with no difference in complication rates. A subsequent systematic review and meta-analysis confirmed a pooled reduction in healing time favoring the cell-suspension arm, with reduced pain scores; however, scar-scale and satisfaction outcomes did not differ significantly between groups.

This study extends that evidence base using the currently marketed RECELL® device, an intra-patient split-site design (which controls for inter-patient variability more efficiently than the parallel-group design used by Hu et al.), and adds long-term (12-month) aesthetic and complication follow-up, including hypertrophic scarring and keloid formation, which prior donor-site trials have not consistently powered for.

Study Design: At the time of STSG harvest, the donor site is divided into two contiguous, comparable halves (e.g., proximal/distal along the anterolateral thigh). Randomization via REDCap assigns which half receives RECELL®. Both halves are dressed with the same transparent polyurethane film dressing so that epithelialization can be assessed serially through the dressing without disturbing the wound bed. Due to the nature of RECELL® application, operating surgeons and the study coordinator cannot be blinded; however, subjects are not informed of their treatment allocation until after the 12-month visit, and outcome assessors evaluate cropped, coded photographs blinded to treatment assignment.

Follow-up visits occur every 2-3 days from POD 5 until both halves reach complete re-epithelialization, then at 4 weeks, 3 months, 6 months, and 12 months. Standardized digital photography, pain and itch VAS, POSAS 2.0, and Vancouver Scar Scale assessments are obtained at pre-specified intervals per the Schedule of Assessments. All data are stored in UC Davis REDCap. Four plastic surgery attendings at UC Davis Medical Center will enroll participants. Safety monitoring is performed by the PI, operating surgeons, blinded reviewers, a plastic surgery resident, a medical student, and a biostatistician, with reports submitted to the UC Davis IRB at periodic Continuing Reviews.