What is this study trying to find out about head and neck reconstruction?

This study is evaluating whether using RECELL4 Autologous Skin Cell Suspension with de-epithelialized tissue improves skin color matching compared to standard grafting methods. Researchers want to understand which technique leads to better healing and higher patient satisfaction. The study is sponsored by Yale University.

Who may be eligible for this head and neck reconstruction clinical trial?

Adults aged 18 years or older with a suitable cutaneous defect requiring reconstructive surgery on the head or neck may be eligible. Participants must be able to consent, understand English questionnaires, and follow post-operative care. Please review eligibility criteria for more details.

Is there any cost to participate in this head and neck reconstruction clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07431099

Skin Color Matching in Head and Neck Reconstructive Surgery Using RECELL4 Autologous Skin Cell Suspension A Prospective, Pilot Study

Led by Yale University · Updated on 2026-05-29

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether using RECELL4 Autologous Skin Cell Suspension ASCS with de-epithelialized tissue provides better skin color matching than standard grafting techniques in patients undergoing head and neck reconstruction. This study aims to compare color match, healing, and patient satisfaction across three reconstruction methods for cutaneous defects in the head and neck region. Participants will have their wound divided into three sections to receive different treatments split-thickness skin graft, de-epithelialized tissue alone, and de-epithelialized tissue combined with RECELL4 ASCS. The intervention is applied on the day of surgery, with all participants receiving the same combined treatment and serving as their own controls. The study compares these methods to see which provides better color matching. After surgery, participants will return for follow-up visits on Day 14 and at 1, 3, and 6 months. During these visits, researchers will measure skin color matching using a handheld colorimeter, assess wound healing and morbidity, collect patient satisfaction data through questionnaires, and monitor for any adverse events. The study tracks outcomes over six months to evaluate the success of the reconstruction methods.

CONDITIONS

Brief Title

Skin Color Matching in Head and Neck Reconstructive Surgery

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Provision of signed and dated informed consent form
Ability to understand and respond to patient-reported outcome measures in English
Willingness to comply with all study procedures and availability for the study duration
Age 18 years or older with ability to give informed consent or assent
Suitable candidate for head and neck reconstructive surgery as determined by surgeon and anesthesiology team
Possession of a cutaneous defect appropriate for split-thickness skin grafting or de-epithelialized tissue reconstruction
Reconstruction to occur within a clinically appropriate window following defect creation (e.g., immediate or delayed within 14 days)
Ability to adhere to post-operative wound care instructions
Reliable means to attend scheduled follow-up visits (in person or via telemedicine if permitted)
Willingness to allow standardized clinical photographs of surgical site for outcome analysis and publication

You will not qualify if you...

Under 18 years of age
Pregnant or lactating individuals
Incarcerated individuals
Cognitively impaired individuals unable to provide informed consent
Inability to tolerate general anesthesia or surgical repair
Known allergy or hypersensitivity to porcine-derived products or trypsin used in RECELL4 preparation
Severe immunosuppression, poorly controlled diabetes, or systemic conditions impairing wound healing or increasing infection risk

Research Team

Stanley Kusaka, BS

Suresh Mohan, MD

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