COmparison of PERforator flaps versus full-thickness skin GRAfts after cutaneous Melanoma excision (COPERGRAM): a prospective observational pilot study protocol

Background: Cutaneous melanoma is an aggressive and potentially lethal form of skin cancer. Surgical excision with appropriate safety margins may result in functional and esthetic impairments. Reconstructive strategies, therefore, aim to achieve the best results without compromising oncological safety. To date, no consensus has been reached regarding the optimal reconstruction strategy. Some authors advocate skin grafting because it may facilitate early detection of local recurrence, but it remains associated with donor-site morbidity and suboptimal morpho-functional outcomes. Other studies have reported improved healing times and esthetic results with flap reconstruction. Nevertheless, it is usually not the first option because of widespread, yet unproven, concern that it may hinder detection of local recurrence. This pilot study will compare healing time, scar quality, quality of life, reconstructive failure, and melanoma recurrence between the two techniques. Methods: COPERGRAM (COmparison of PERforator flaps versus full-thickness skin GRAfts after cutaneous Melanoma excision) is a single-center, prospective, non-interventional pilot study. It will include patients aged ≥18 years who are scheduled to undergo surgery for stage I or II cutaneous melanoma, regardless of location, when primary wound closure is not possible. The target sample size is 40 patients: 20 reconstructed with full-thickness skin grafts and 20 with perforator flaps. The primary endpoint will be the healing time between the two groups. Secondary endpoints will include scar appearance and patient quality of life (on day 15, at the first visit after complete healing if healing occurs after day 15, and at 6 and 12 months), reconstructive failure, and melanoma recurrence (local, nodal, or metastatic). Discussion: This study aims to provide preliminary evidence regarding the effectiveness of perforator flaps over skin grafts following melanoma excision with safety margins, when primary closure is not possible. We hypothesize that perforator flaps may provide superior functional and esthetic outcomes without compromising oncologic prognosis. We will also assess the quality of life over a 12-month follow-up period.