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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.
Shoreline Surgery Center
Guilford, Connecticut, United States
RECRUITINGYale Milford Otolaryngology Clinic
Milford, Connecticut, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGColor match at the reconstruction site
Color match is measured with a handheld colorimeter using ΔE00 color difference formula. Values will be computed from these data to quantify skin color match with lower scores indicating closer match. Score range 0-5.
Time frame: Postoperative assessments at Day 14 and months 1, 3, and 6
FACE-Q patient satisfaction questionnaire
FACE-Q is a patient-reported outcome questionnaire for facial aesthetics with a total score range of 0-100 that measure satisfaction with appearance, quality of life, and procedure. Higher scores indicating better outcomes.
Time frame: Month 3 and 6
Mean healing time
Healing time in days of both the graft recipient and donor sites
Time frame: Postoperative assessments at Day 14 and months 1, 3, and 6
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