Skin Color Matching in Head and Neck Reconstructive Surgery Using RECELL® Autologous Skin Cell Suspension: A Prospective, Pilot Study
Yale University
Summary
This study will examine whether cutaneous reconstruction with RECELL® atop de-epithelialized tissue provides better skin color matching than standard grafting methods. The goal is to compare color match, healing, and patient satisfaction across three reconstruction techniques. Color matching will be assessed using colorimeter-based ΔE00 measurements at set postoperative intervals. All patients will receive the same intervention.
Description
Patients with head and neck cutaneous defects requiring skin grafting for reconstruction will have their wound bed divided into three sections: (1) split-thickness skin graft, (2) de-epithelialized tissue, (3) de-epithelialized tissue + RECELL® ASCS. Color matching will be determined via a handheld colorimeter and calculated using the CIEDE2000 color difference formula. Healing, morbidity, and patient satisfaction outcomes will be assessed at interval post-operative clinic visits. Intervention is administered on day of surgery. Following surgery, participants return for postoperative assessmen…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provision of signed and dated informed consent form * Ability to understand and respond to patient-reported outcome measures in English * Stated willingness to comply with all study procedures and availability for the duration of the study * Subjects aged ≥18 may be included, provided they or their legal guardian are able to provide informed consent or assent in accordance with institutional policies * Is deemed a suitable candidate for head and neck reconstructive surgery, the basis of which will be determined by the surgeon performing the procedure as well as pre-opera…
Interventions
- DeviceRECELL® Autologous Cell Harvesting Device
RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.
Locations (2)
- Yale Milford Otolaryngology ClinicMilford, Connecticut
- Yale New Haven HospitalNew Haven, Connecticut