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)

January 14, 2026 updated by: Nantes University Hospital

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

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for cutaneous melanoma

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
skin graft (routine care)
Skin grafting decided by the multidisciplinary tumor board
perforator flap (routine care)
perforator flap decided by the multidisciplinary tumor board

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.
up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Mathilde Gaudian, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

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)?

YES

IPD Plan Description

Study protocol + article

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stage II Cutaneous Melanoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe