Can a skin cell spray help scars blend in? new study aims to find out
NCT ID NCT07431099
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using RECELL® — a device that creates a spray from a patient's own skin cells — can improve skin color matching after head and neck reconstructive surgery. Twenty adults who need this surgery will receive the treatment, and their color match, healing, and satisfaction will be tracked. The goal is to see if this approach gives better cosmetic results than standard methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RECELL® Autologous Skin Cell Suspension (device)
- What this could lead to
- If it works, this could lead to better cosmetic outcomes and higher patient satisfaction after head and neck reconstruction.
- What could go wrong
- This is a very small pilot study (20 people) with no control group, so results may not apply broadly. The device is already approved for other uses, but its benefit for color matching is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shoreline Surgery Center
RECRUITINGGuilford, Connecticut, 06437, United States
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Yale Milford Otolaryngology Clinic
RECRUITINGMilford, Connecticut, 06460, United States
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Yale New Haven Hospital
RECRUITINGNew Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Experimental pill HG146 put to the test against rare head and neck cancer
- Can a dental assistant keep cancer Patients' mouths healthier during radiation?
- Why do Non-Smokers get head and neck cancer? scientists probe tumor DNA
- Re-irradiation plus cetuximab targets head and neck tumors that return
- Sharper tumor maps: PET scans could tighten radiation beams
- Five days of radiation instead of weeks: a new test for head and neck cancer