Etude rétrospective Monocentrique MATRIX | NCT06415929

Studies
Etude rétrospective Monocentrique MATRIX

NCT06415929

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

May 16, 2024Actual

Enrollment

15Actual

Phase

Not provided

Conditions

Melanoma

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2024Actual

Primary Completion Date

Apr 15, 2024Actual

Completion Date

Apr 15, 2024Actual

First Submitted Date

May 13, 2024

First Submission Date that Met QC Criteria

May 13, 2024

First Posted Date

May 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

"Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy.

Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patient with history		Patient with history of complete exeresis of the nail apparatus, with dermal matrix repair and total skin grafting

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life evaluation	Quality of life evaluation- questionnaire	3 months too 36 months after the surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Adult patients who have undergone complete nail removal for malignancy - Reconstructed with INTEGRA dermal matrix and total skin graft.

Exclusion Criteria:

-Minor patients -Patients who have undergone complete removal of the nail apparatus for malignancy but have been reconstructed in another way (flap, isolated skin graft)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hopital de soins tertiaires- Hopital Pasteur 2-Nice

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elise Elise	Centre Hospitalier Universitaire de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU NiICE		Nice	Alpes Maritimes	0600	France

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided