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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

NCT07354152 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-01-21

No results posted yet for this study

Summary

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.

Conditions

  • Stage II Cutaneous Melanoma

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Mathilde Gaudian · Nantes University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-05-01
Completion
2027-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07354152 on ClinicalTrials.gov