Recruiting

RECELL®

Sponsor:

Yale University

Code:

NCT07431099

Conditions

Head and Neck Cancer

Head and Neck Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RECELL® Autologous Cell Harvesting Device

Study Details

Brief summary:

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.

Conditions

Head and Neck Cancer

Head and Neck Trauma

Study ID

NCT07431099

Start date

May 20, 2026

Status verified date

May, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

RECELL® Autologous Cell Harvesting Device

RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stanley Kusaka, BS

971-325-8502stanley.kusaka@yale.edu

Suresh Mohan, MD

203-260-4622suresh.mohan@yale.edu

Locations

Shoreline Surgery Center

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Suresh Mohan, MD

203-260-4622suresh.mohan@yale.edu

Yale Milford Otolaryngology Clinic

Recruiting

Milford, Connecticut, United States, 06460

Contacts

Suresh Mohan, MD

203-260-4622suresh.mohan@yale.edu

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Suresh Mohan, MD

203-260-4622suresh.mohan@yale.edu

More Information

Sponsor

Yale University

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • Head and neck cutaneous defects
  • Head and neck reconstructive surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-05-29.