University of California, Davis
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 i…
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, inde…
RECELL® (FDA PMA BP170122) is a point-of-care device that processes a small split-thickness skin biopsy into a non-cultured autologous skin cell suspension (ASCS) containing keratinocytes, melanocytes, and fibroblasts. The suspension is sprayed directly onto the randomized donor-site half intraoperatively to seed re-epithelialization, followed by application of a transparent polyurethane film dressing. This application to STSG donor sites represents an off-label use of the device. The device is classified as non-significant risk and is exempt from the IDE requirement.
Standard institutional transparent polyurethane film dressing (Telfa or Mepilex Ag) applied to the control half of the STSG donor site immediately following graft harvest. This represents the current institutional standard of care for STSG donor-site management at UC Davis Medical Center. The dressing is left undisturbed for approximately five days and changed thereafter only per surgeon judgment or if compromised (soiled, leaking, or non-adherent).
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