NCT07431099

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable head-and-neck-cancer

Timeline
28mo left

Started Mar 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

February 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Head and Neck Cancer

Keywords

Head and neck reconstructive surgeryHead and neck cutaneous defects

Outcome Measures

Primary Outcomes (1)

  • Color match at the reconstruction site

    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.

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

Secondary Outcomes (2)

  • FACE-Q patient satisfaction questionnaire

    Month 3 and 6

  • Mean healing time

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

Study Arms (1)

Participants with head and neck cutaneous defect needing skin grafting

EXPERIMENTAL

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.

Device: RECELL® Autologous Cell Harvesting Device

Interventions

RECELL® Autologous Cell Harvesting DeviceDEVICE

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

Participants with head and neck cutaneous defect needing skin grafting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Milford Otolaryngology Clinic

Milford, Connecticut, 06460, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Suresh Mohan, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley Kusaka, BS

CONTACT

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

Suresh Mohan, MD

CONTACT

734-576-0928suresh.mohan@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Adults undergoing head and neck cutaneous reconstruction requiring skin grafting is the population of interest. Patients will serve as their own internal controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2026

First Posted

February 24, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(2)