Review of the Literature and Serie of Patients Who Underwent Reconstruction After Wide Local Excision of Nail Apparatus for Melanoma

NCT06861023 | Recruiting

• 1 other identifier: 25Chirplast01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Melanomas of the nail bed are often diagnosed at the locally advanced stage. The standard treatment was amputation of the finger or toe, but it has now been established that enlarged excision of the nail plate is sufficient under certain conditions. Reconstruction of the nail system can be performed by several techniques. Here, the investigators present a series of patients reconstructed by INTEGRA (dermal matrix) and skin graft

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Functional and cosmetic patient satisfaction

  Scores AOFAS (feet)(score ranging from 0, maximum disability, to 90, no disability), Scores QUICK DASH(score ranging from 0, no disability, to 100, maximum disability) and Mayowrist score (hands)(score ranging from 0, maximum disability, to 100, no disability)

  3 months minimum postoperative

Secondary Outcomes (2)

• Post-operative complications

  3 months minimum postoperative

• Recurrence of the disease

  3 months minimum postoperative

Study Arms (1)

Patients who have undergone extensive nail resection with reconstruction

Other: Patients who have undergone extensive nail resection with reconstruction

Interventions

Patients who have undergone extensive nail resection with reconstruction OTHER

The investigators studied a population of 10 patients who underwent nail and nail matrix excision surgery as part of the treatment of subungual melanoma, as well as the reconstruction, the investigators opted for. The specific intervention of this study is based on late postoperative questions (after 3 months)

Also known as: Excision of the nail apparatus with flap reconstruction or INTEGRA + skin graft.

Patients who have undergone extensive nail resection with reconstruction

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone melanoma surgery in the plastic surgery department of the Pasteur Hospital

You may qualify if:

• Patients who have undergone enlarged resection of the nail apparatus with immediate or delayed reconstruction in the setting of acral melanoma of the fingers or toes.

You may not qualify if:

• Patients who have amputation, opposition of the pateint to the study.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU NICE

Nice, Alpes Maritimes, 06000, France

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Plastic Surgery Procedures; Skin Transplantation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Transplantation

Central Study Contacts

ELISE LUPON

CONTACT

06 26 30 63 23; lupon.e@chu-nice.fr

LUC CHOUQUET

CONTACT

06 42 75 07 14; ettooluc@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: January 15, 2025
• Primary Completion: February 28, 2025
• Study Completion: March 25, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

FR (1)