NCT07354152: COPERGRAM1

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

Not yet recruiting Last updated 21 January 2026

What this trial tests

trial in Stage II Cutaneous Melanoma in 40 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 May 2027

1 May 2027

Quick facts

Lead sponsor	Nantes University Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	40
Start date	1 February 2026
Primary completion	1 May 2027
Estimated completion	1 May 2027

Conditions studied

• Stage II Cutaneous Melanoma — all drugs for Stage II Cutaneous Melanoma →

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Stage II Cutaneous Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.