COmparison of the Use of a PERforator Flap Versus Total Skin GRAft in the Management of Loss of Substance After Resection of Cutaneous Melanoma - Pilot Study

Обзор

Melanoma is an aggressive and potentially fatal skin cancer and was the fifth most commonly diagnosed cancer among both men and women in the United States in 2022. When detected early, cutaneous melanoma has a favorable prognosis, with a 5-year survival rate exceeding 90%. Because melanoma frequently affects younger patients, wide local excision according to international guidelines may result in substantial functional and aesthetic morbidity. Reconstruction is therefore a critical component of locoregional management and should aim to optimize functional and aesthetic outcomes without compromising oncologic control. To date, no consensus exists regarding the optimal reconstructive strategy. Skin grafts are often favored for their presumed ability to facilitate early detection of local recurrence but are associated with donor-site morbidity and suboptimal morphofunctional outcomes. Flap reconstruction has been reported to improve healing time and aesthetic results; however, it is not commonly considered first-line after melanoma excision, largely due to the unsubstantiated concern that flaps may delay recurrence detection. Notably, objective data supporting this concern are lacking. Only two retrospective studies have addressed this issue. The largest, including 165 patients, reported that perforator-based pedicled flaps achieved favorable functional and aesthetic outcomes without adversely affecting locoregional disease control. A smaller study of facial melanoma similarly found immediate reconstruction with a facial artery perforator flap to be safe and aesthetically satisfactory. In our institution, both skin grafts and flap reconstructions are used following multidisciplinary discussion. We therefore aim to comparatively evaluate wound healing after margin re-excision and patient-reported quality of life following melanoma excision, regardless of tumor stage or location, to determine whether one reconstructive approach provides superior clinical or functional benefit in routine practice.

Подробное описание

This study compares two groups of patients who underwent different standard-of-care reconstructive techniques following margin re-excision for stage II cutaneous melanoma, with the reconstructive approach selected during a multidisciplinary tumor board dedicated to melanoma management.

Первичные конечные точки

• wound healing [Срок оценки: up to 3 months]

Критерии участия

Критерии включения

• Adult men or women (≥ 18 years)
• Patients with cutaneous melanoma of any stage (I, II, or III) according to the AJCC Cancer Staging Manual, 8th edition (2017), diagnosed prior to surgery
• Non-closable surgical defect after margin re-excision

Критерии исключения

• Patients with microscopic or macroscopic nodal involvement when the sentinel lymph node has been removed
• Patients with distant metastases identified on ultrasound and/or CT scan and/or PET-CT, when performed
• Surgical contraindication to perforator flap reconstruction
• Pregnant or breastfeeding women
• Patients without health insurance coverage
• Vulnerable individuals: persons deprived of liberty, under legal guardianship, or under curatorship

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CHU Nantes-Department of Severe Burns and Aesthetic Surgery — Nantes

Идентификаторы

NCT: NCT07354152 · AP_UL_02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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