NCT07431099

Skin Color Matching in Head and Neck Reconstructive Surgery

Skin Color Matching in Head and Neck Reconstructive Surgery Using RECELL® Autologous Skin Cell Suspension: A Prospective, Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 assessments at Day 14 and months 1, 3, and 6, during which clinical wound evaluations and adverse event checks are performed and color match is measured. The primary objective of this study will be to assess whether RECELL® Autologous Skin Cell Suspension in conjunction with de-epithelialized tissue will provide superior color matching compared to de-epithelialized tissue alone or split-thickness skin grafting. Secondary objectives include assessment of healing, morbidity, and patient-reported satisfaction with their skin grafting results.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	RECELL® Autologous Cell Harvesting Device	RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2026-02-24
• Last updated: 2026-02-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study