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

February 28, 2025 updated by: Centre Hospitalier Universitaire de Nice

Review of the Literature and Retrospective, Single-centre Study of a Series of Patients Who Underwent Reconstruction After Complete Nail Resection.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Alpes Maritimes
      • Nice, Alpes Maritimes, France, 06000
        • Recruiting
        • CHU Nice
        • Contact:
        • Contact:
          • ELISE LUPON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who have undergone extensive nail resection with reconstruction
Other: Patients who have undergone extensive nail resection with reconstruction
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)
Other Names:
  • Excision of the nail apparatus with flap reconstruction or INTEGRA + skin graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional and cosmetic patient satisfaction
Time Frame: 3 months minimum postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications
Time Frame: 3 months minimum postoperative
Presence or absence of Postoperative complications (inclusion cyst, nail spicule, need for repeat surgery).
3 months minimum postoperative
Recurrence of the disease
Time Frame: 3 months minimum postoperative
Recurrence of the disease.
3 months minimum postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25Chirplast01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe