CHU Nantes-Department of Severe Burns and Aesthetic Surgery
Nantes, 44000, France
Location status: Recruiting
NCT Number: NCT07354152
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Nantes, 44000, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Contact information is provided by the study sponsor or research team.
Alexandra Poinas, PhD
CONTACT
Ugo Lancien, MD
CONTACT
Nantes University Hospital
Other
Acronym: COPERGRAM1
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View the official ClinicalTrials.gov record (opens in a new tab)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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