Head and Neck CancerRECOLOR-HNNCT07431099
Skin Color Matching in Head and Neck Reconstructive Surgery
A study testing RECELL® Autologous Cell Harvesting Device in people with Head and Neck Cancer and Head and Neck Trauma, run by Yale University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Trauma
- What is being tested?
- RECELL® Autologous Cell Harvesting Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 May 2026to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Shoreline Surgery Center
Guilford, Connecticut, 06437
Suresh Mohan, MD, 203-260-4622, suresh.mohan@yale.edu
- Recruiting
Yale Milford Otolaryngology Clinic
Milford, Connecticut, 06460
Suresh Mohan, MD, 203-260-4622, suresh.mohan@yale.edu
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
Suresh Mohan, MD, 203-260-4622, suresh.mohan@yale.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancer, Head and Neck Trauma
- Being tested
- RECELL® Autologous Cell Harvesting Device
- Keywords
- Head and neck cutaneous defects, Head and neck reconstructive surgery
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECELL® Autologous Cell Harvesting DeviceDevice
RECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RECELL® Autologous Cell Harvesting Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative assessments at Day 14 and months 1, 3, and 6
Secondary outcomes (2)
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.
Measured: Month 3 and 6
Mean healing time
Healing time in days of both the graft recipient and donor sites
Measured: Postoperative assessments at Day 14 and months 1, 3, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start20 May 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adults undergoing head and neck cutaneous reconstruction requiring skin grafting is the population of interest. Patients will serve as their own internal controls.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suresh Mohan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431099
- Sponsor's protocol ID
- 2000040540
- Acronym
- RECOLOR-HN
- Status last verified
- May 2026
- First submitted
- 18 Feb 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Color Matching in Head and Neck Reconstructive Surgery Using RECELL® Autologous Skin Cell Suspension: A Prospective, Pilot Study
- ClinicalTrials.gov ID
- NCT07431099
- Acronym / sponsor ID
- RECOLOR-HN / 2000040540
- Conditions
- Head and Neck Cancer, Head and Neck Trauma
- Keywords
- Head and neck cutaneous defects, Head and neck reconstructive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 20 May 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adults undergoing head and neck cutaneous reconstruction requiring skin grafting is the population of interest. Patients will serve as their own internal controls.
| Arm | Type | Receives |
|---|---|---|
| Participants with head and neck cutaneous defect needing skin grafting | Experimental | Device: RECELL® Autologous Cell Harvesting DeviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Member of one or more of the following vulnerable populations:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECELL® Autologous Cell Harvesting DeviceRECELL Autologous Skin Cell Suspension (ASCS) will be used for color match and healing. | Device | Participants with head and neck cutaneous defect needing skin grafting |
Primary outcome
Color match at the reconstruction site
Time frame: Postoperative 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.
2 secondary outcomes
FACE-Q patient satisfaction questionnaire
Time frame: Month 3 and 6
Mean healing time
Time frame: Postoperative assessments at Day 14 and months 1, 3, and 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suresh Mohan, MD principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RECELL® Autologous Cell Harvesting Device in people with Head and Neck Cancer and Head and Neck Trauma, run by Yale University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stanley Kusaka, BS (971-325-8502, stanley.kusaka@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color match at the reconstruction site (time frame: Postoperative assessments at Day 14 and months 1, 3, and 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.