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New treatment option for Head and Neck Cancer
Official title Skin Color Matching in Head and Neck Reconstructive Surgery
ClinicalTrials.gov ID: NCT07431099
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
- people aged ≥18 may be included, provided they or their legal guardian are able to provide informed consent or assent in accordance with...
- Is deemed a suitable candidate for head and neck reconstructive surgery, the basis of which will be determined by the surgeon performing the...
You likely can't join 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...
- Pregnant/lactating individuals: Pregnant and lactating individuals are excluded due to the lack of safety data on RECELL® administration during...
- Incarcerated individuals: The ability to provide fully voluntary and uncoerced consent may be compromised in correctional settings. Furthermore...
- Cognitively impaired individuals: Cognitively impaired individuals are excluded because they may lack the capacity to provide fully informed consent...
- Inability to tolerate general anesthesia, or any other circumstance that would render the subject unable to undergo surgical repair of their...
See the full eligibility 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
- people 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...
- 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
- people 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
- 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...
- 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...
- 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
- people with known severe immunosuppression, poorly controlled diabetes, or other systemic conditions that could impair wound healing or increase infection risk
The study team makes the final eligibility decision.
Where it's taking place
- Guilford, Connecticut, United States
- Milford, Connecticut, United States
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guilford, Connecticut, United States; Milford, Connecticut, United States; New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.