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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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07354152
Acronym
COPERGRAM1
Enrollment
40
Registered
2026-01-21
Start date
2026-02-01
Completion date
2027-05-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II Cutaneous Melanoma

Keywords

melanoma, skin graft, perforator flap

Brief summary

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.

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.

Interventions

None listed

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
wound healingup to 3 monthsTo 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.

Countries

France

Contacts

CONTACTUgo Lancien, MD
ugo.lancien@chu-nantes.fr02 40 08 73 04
CONTACTAlexandra Poinas, PhD
alexandra.poinas@chu-nantes.fr+33 2 53 48 28 57
PRINCIPAL_INVESTIGATORMathilde Gaudian

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026