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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

Recruitingn/aAges 18 Years - anyAllNantes University Hospital
NCT07354152 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

1 site
CHU Nantes-Department of Severe Burns and Aesthetic Surgery
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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