Skin Color Matching in Head and Neck Reconstructive Surgery (RECOLOR-HN)

Skin Color Matching in Head and Neck Reconstructive Surgery Using RECELL® Autologous Skin Cell Suspension: A Prospective, Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Head and Neck Trauma
• Intervention / Treatment: Device: RECELL® Autologous Cell Harvesting Device

Detailed Description

Patients with head and neck cutaneous defects requiring skin grafting for reconstruction will have their wound bed divided into three sections: (1) split-thickness skin graft, (2) de-epithelialized tissue, (3) de-epithelialized tissue + RECELL® ASCS. Color matching will be determined via a handheld colorimeter and calculated using the CIEDE2000 color difference formula. Healing, morbidity, and patient satisfaction outcomes will be assessed at interval post-operative clinic visits. Intervention is administered on day of surgery. Following surgery, participants return for postoperative assessments at Day 14 and months 1, 3, and 6, during which clinical wound evaluations and adverse event checks are performed and color match is measured.

The primary objective of this study will be to assess whether RECELL® Autologous Skin Cell Suspension in conjunction with de-epithelialized tissue will provide superior color matching compared to de-epithelialized tissue alone or split-thickness skin grafting.

Secondary objectives include assessment of healing, morbidity, and patient-reported satisfaction with their skin grafting results.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stanley Kusaka, BS; Phone Number: 971-325-8502; Email: stanley.kusaka@yale.edu
• Study Contact Backup: Name: Suresh Mohan, MD; Phone Number: 203-260-4622; Email: suresh.mohan@yale.edu

Study Locations

• United States
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Recruiting
      • Shoreline Surgery Center
      • Contact: Suresh Mohan, MD; Phone Number: 203-260-4622; Email: suresh.mohan@yale.edu
    • Milford, Connecticut, United States, 06460
      • Recruiting
      • Yale Milford Otolaryngology Clinic
      • Contact: Suresh Mohan, MD; Phone Number: 203-260-4622; Email: suresh.mohan@yale.edu
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Suresh Mohan, MD; Phone Number: 203-260-4622; Email: suresh.mohan@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: RECELL® Autologous Cell Harvesting Device; RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACE-Q patient satisfaction questionnaire	FACE-Q is a patient-reported outcome questionnaire for facial aesthetics with a total score range of 0-100 that measure satisfaction with appearance, quality of life, and procedure. Higher scores indicating better outcomes.	Month 3 and 6
Mean healing time	Healing time in days of both the graft recipient and donor sites	Postoperative assessments at Day 14 and months 1, 3, and 6

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Suresh Mohan, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Head and neck reconstructive surgery; Head and neck cutaneous defects
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 2000040540

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No