Study of the Cutaneous Reinnervation After Burn

NCT ID: NCT02356354

Last Updated: 2016-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is to understand why the regeneration of the cutaneous sensory nerve fibers is poor in post-burn scar.

The presence or the lack of several molecular factors known to regulate neuronal cell development will be evaluate and compared within biopsies from healthy skin and post-burn scar.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-burn Innervation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Skin biopsy

On the same patient, a biopsy of post-burn scar is removed. A second one is removed from healthy skin.

Group Type OTHER

Skin biopsy

Intervention Type PROCEDURE

2 biopsies are done on the same patient : 20 cutaneous biopsies from post-burn scar and from healthy skin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Skin biopsy

2 biopsies are done on the same patient : 20 cutaneous biopsies from post-burn scar and from healthy skin

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Major patients
* At least one year back deep burn (2nd and 3rd degrees), and allowing the comparison between the post-burn scar dermatome and the healthy opposite dermatome
* Patients always followed in the service of Plastic surgery of the hospital of Brest
* Informed consent and paper of the patient after information of the objective of the study and the protocol
* Analog Visual scales for pain and/or pruritus (EVA): greater than or equal to 3
* Simple Verbal scales for the pain and/or the pruritus ( EVS): pain / pruritus moderated to intense
* Membership to the Social Security

Exclusion Criteria

* Allergy to xylocaine
* Non-Caucasian patients
* Treatments having an effect on the pain and/or the pruritus
* Sun or UV exposure several days preceding or following the biopsies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laurent MISERY

Role: PRINCIPAL_INVESTIGATOR

CHRU de Brest

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, France, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RB 14.190 NERVAL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.