Perforator flap vs full-th thickness skin graft after melanoma surgery
Official title: 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
Run by Nantes University Hospital · NCT07354152 · Data updated 2026-11-12
This observational pilot compares perforator flap reconstruction to skin grafting after margin re-excision for stage II cutaneous melanoma to see which approach supports better healing and appearance.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes, Nantes) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07354152 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with cutaneous melanoma who have non-closable defects after margin re-excision.
✕Probably not a fit
Patients with distant metastases, nodal involvement after sentinel node removal, or contraindications to perforator flap reconstruction may not experience improved outcomes from this comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines two standard reconstruction methods used after margin re-excision in adults with stage II cutaneous melanoma. Patients are assigned to the reconstructive technique discussed at a melanoma multidisciplinary tumor board, reflecting real-world, current practice. Outcomes focus on healing, function, and aesthetics, without altering the cancer treatment plan. The observational design means there is no randomization or experimental intervention beyond standard care.
Why it matters
Potential benefit: If successful, the findings may guide clinicians on choosing reconstruction methods that balance oncologic safety with better functional and cosmetic results.
How similar studies have gone: Previous reports suggest flap reconstructions can improve healing and aesthetics, but there is no definitive consensus, making this pilot informative.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
CHU Nantes-Department of Severe Burns and Aesthetic Surgery
Nantes, Nantes, France Recruiting
Study contacts
- Principal investigator: Mathilde Gaudian — Nantes University Hospital
- Study coordinator: Ugo Lancien, MD
- Email: ugo.lancien@chu-nantes.fr
- Phone: 02 40 08 73 04
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.