RECELL® for Head and Neck Cancer Reconstruction

(RECOLOR-HN Trial)

Not yet recruiting at 1 trial location

Overseen By Stanley Kusaka, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Children, Pregnant, Incarcerated, Cognitively impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Day of surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Suresh Mohan, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 or older and able to give consent for myself or through my legal guardian.

Provision of signed and dated informed consent form

I can read and answer questions in English.

Exclusion Criteria

Member of one or more of the following vulnerable populations: Children/under the age of 18, Pregnant/lactating individuals, Incarcerated individuals, Cognitively impaired individuals

Known allergy or hypersensitivity to porcine-derived products or trypsin, which is used in the enzymatic preparation of the RECELL® autologous skin cell suspension

I cannot safely have general anesthesia or surgery for my skin condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reconstructive surgery with RECELL® ASCS and other grafting techniques

Day of surgery

1 visit (in-person)

Postoperative Assessment

Participants return for postoperative assessments including clinical wound evaluations, adverse event checks, and color match measurements

6 months

4 visits (in-person) at Day 14, Month 1, Month 3, and Month 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RECELL®

How Is the Trial Designed?

Group I: Participants with head and neck cutaneous defect needing skin grafting Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+