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Autologous Skin Cell Suspension (RECELL®) for Accelerated Healing of Split-Thickness Skin Graft Donor Sites: A Randomized, Intra-Patient (Split-Site) Controlled Trial
Sponsor: University of California, Davis
Summary
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-11
Completion Date
2030-11
Last Updated
2026-10-22
Healthy Volunteers
No
Interventions
RECELL® Autologous Cell Harvesting Device
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 Transparent Film Dressing
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).
Locations (1)
UC Davis Medical Center
Sacramento, California, United States