Skin Color Matching in Head and Neck Reconstructive Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Color match at the reconstruction site [Срок оценки: Postoperative assessments at Day 14 and months 1, 3, and 6]

Вторичные конечные точки (2)

• FACE-Q patient satisfaction questionnaire [Срок оценки: Month 3 and 6]
• Mean healing time [Срок оценки: Postoperative assessments at Day 14 and months 1, 3, and 6]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Shoreline Surgery Center — Guilford
• Yale Milford Otolaryngology Clinic — Milford
• Yale New Haven Hospital — New Haven

Идентификаторы

NCT: NCT07431099 · 2000040540

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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