Skin Color Matching in Head and Neck Reconstructive Surgery

This study is looking at ways to improve skin color matching after reconstructive surgery for head and neck cancer or trauma. It's testing if a treatment called RECELL® Autologous Cell Harvesting Device, which uses your own skin cells, can provide a better color match than standard skin grafting. Researchers will compare three different reconstruction techniques on your wound: a standard skin graft, de-epithelialized tissue (skin with the top layer removed), and de-epithelialized tissue combined with RECELL®. The main goal is to see which method results in the best color match, measured at 14 days, 1 month, 3 months, and 6 months after surgery. They will also look at how well the wound heals and your satisfaction with the results. You may be able to join if you are 18 or older and can understand and respond to questions in English. The study plans to enroll 20 participants, but its current status is unclear.

Study design: This is an interventional study that will compare three different reconstruction techniques on each participant's wound. It plans to enroll 20 participants.
What's involved: You will have surgery where the intervention is administered. After surgery, you will return for follow-up visits at Day 14, and months 1, 3, and 6 for assessments.
Compensation: Not stated in the trial record.
Follow-up: You will be followed for 6 months after surgery for assessments.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Skin Color Matching in Head and Neck Reconstructive Surgery

Recruiting

NAAges 18+InterventionalTreatment

Yale University

~20 participants

Updated 2026-05-29 on ClinicalTrials.gov

What's tested:RECELL® Autologous Cell Harvesting Device

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Color match at the reconstruction site

Measured over Postoperative assessments at Day 14 and months 1, 3, and 6

Conditions

Head and Neck Cancer

Head and Neck Trauma

Where it's being run

3 sites across 1 states

Connecticut3

Study leadership

Suresh Mohan, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Stanley Kusaka, BS

[email protected]

971-325-8502

Email the study team

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form

Ability to understand and respond to patient-reported outcome measures in English

Stated willingness to comply with all study procedures and availability for the duration of the study

Subjects aged ≥18 may be included, provided they or their legal guardian are able to provide informed consent or assent in accordance with institutional policies

Is deemed a suitable candidate for head and neck reconstructive surgery, the basis of which will be determined by the surgeon performing the procedure as well as pre-operative assessment by the anesthesiology team

Possessing a cutaneous defect of a size, location, and depth deemed appropriate for either split-thickness skin grafting or de-epithelialized tissue reconstruction, as assessed preoperatively and/or intraoperatively by the surgical team

Reconstruction must occur within a clinically appropriate window following defect creation (e.g., immediate or delayed reconstruction within 14 days), depending on institutional protocol and wound status

Ability to adhere to post-operative discharge wound care instructions

Subjects must have reliable means of attending scheduled follow-up visits for outcome assessments (in person or via telemedicine if permitted)

Willingness to allow standardized clinical photographs of the surgical site to be taken and used for outcome analysis and potential publication

Exclusion

Member of one or more of the following vulnerable populations:

Children/under the age of 18: Aesthetic outcomes and satisfaction measures, such as those used in this study (e.g., FACE-Q), are not validated in children and may not yield reliable or interpretable results.

Pregnant/lactating individuals: Pregnant and lactating individuals are excluded due to the lack of safety data on RECELL® administration during pregnancy or breastfeeding.

Incarcerated individuals: The ability to provide fully voluntary and uncoerced consent may be compromised in correctional settings. Furthermore, consistent post-operative follow-up and outcome assessments, critical to the integrity of the study, may not be feasible due to restrictions on transportation, communication, and continuity of care.

Cognitively impaired individuals: Cognitively impaired individuals are excluded because they may lack the capacity to provide fully informed consent. Given that study participation involves outcome assessments (e.g., satisfaction surveys), full comprehension and participation are essential, and surrogate consent is not appropriate for this study.

Inability to tolerate general anesthesia, or any other circumstance that would render the subject unable to undergo surgical repair of their cutaneous defect

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

Subjects with known severe immunosuppression, poorly controlled diabetes, or other systemic conditions that could impair wound healing or increase infection risk

What this trial measures

Color match at the reconstruction sitePostoperative assessments at Day 14 and months 1, 3, and 6
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.

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