Skin color matching in head and neck reconstruction with RECELL on de-epithelialized tissue

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with head and neck skin defects requiring grafts will have three reconstruction options compared on color match, healing, and satisfaction: split-thickness skin graft, de-epithelialized tissue, and de-epithelialized tissue plus RECELL autologous cell suspension. Color differences will be measured with a handheld colorimeter using the CIEDE2000 formula at postoperative visits. Assessments occur after surgery with follow-ups at Day 14 and months 1, 3, and 6, including wound evaluation and adverse events. The primary goal is to determine if RECELL with de-epithelialized tissue yields superior color matching versus the other methods, with secondary aims assessing healing, morbidity, and patient-reported satisfaction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Shoreline Surgery Center
  Guilford, Connecticut, United States Recruiting
• Yale Milford Otolaryngology Clinic
  Milford, Connecticut, United States Recruiting
• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Suresh Mohan, MD — Yale University
• Study coordinator: Stanley Kusaka, BS
• Email: stanley.kusaka@yale.edu
• Phone: 971-325-8502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.