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 (COPERGRAM1)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alexandra Poinas, PhD
- Phone Number: +33 2 53 48 28 57
- Email: alexandra.poinas@chu-nantes.fr
Study Contact Backup
- Name: Ugo Lancien, MD
- Phone Number: 02 40 08 73 04
- Email: ugo.lancien@chu-nantes.fr
Study Locations
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Nantes
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Nantes, Nantes, France, 44000
- Recruiting
- CHU Nantes-Department of Severe Burns and Aesthetic Surgery
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Contact:
- Alexandra Poinas
- Phone Number: +33 2 40 08 33 33
- Email: alexandra.poinas@chu-nantes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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skin graft (routine care)
Skin grafting decided by the multidisciplinary tumor board
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perforator flap (routine care)
perforator flap decided by the multidisciplinary tumor board
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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up to 3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mathilde Gaudian, Nantes university hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP_UL_02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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