Skin Color Matching in Head and Neck Reconstructive Surgery

Part of paid clinical trials in Guilford, Connecticut.

Sponsor
Yale University
Study ID
NCT07431099
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 20, 2026
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with head and neck cutaneous defect needing skin grafting
    Participants with cutaneous defects of the head and neck requiring skin grafting will have their defect split into three sections and closed with one of the following: (1) split-thickness skin graft (STSG), (2) de-epithelialized tissue alone, or (3) de-epithelialized tissue with RECELL® ASCS. All participants will receive the same intervention and will serve as their own controls. STSG and de-epithelialized tissue alone are each currently used standards of care.

Primary Outcome Measure

Color match at the reconstruction site [ Time Frame: Postoperative assessments at Day 14 and months 1, 3, and 6 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Shoreline Surgery CenterGuilfordConnecticut06437
Suresh Mohan, MD
[email protected]
203-260-4622
Yale Milford Otolaryngology ClinicMilfordConnecticut06460
Suresh Mohan, MD
[email protected]
203-260-4622
Yale New Haven HospitalNew HavenConnecticut06520
Suresh Mohan, MD
[email protected]
203-260-4622

Find similar trials in Guilford, CT

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Head and neck cancer
By specialty
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By research site
Shoreline Surgery Center· Guilford, CTYale Milford Otolaryngology Clinic· Milford, CTYale New Haven Hospital· New Haven, CT

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