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NCT Number: NCT07354152

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nantes-Department of Severe Burns and Aesthetic Surgery

Nantes, 44000, France

Location status: Recruiting

Location contact

Alexandra Poinas

CONTACT

[email protected]

+33 2 40 08 33 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. wound healing

    Time frame: up to 3 months

    To compare wound healing time, measured in days, between two groups of patients with stage II cutaneous melanoma of the trunk, abdomen, or limbs who underwent different reconstructive techniques following margin re-excision: skin grafting (gold standard) versus perforator-based flap reconstruction.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Poinas, PhD

CONTACT

[email protected]

+33 2 53 48 28 57

Ugo Lancien, MD

CONTACT

[email protected]

02 40 08 73 04

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: COPERGRAM1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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