Study of the Cutaneous Reinnervation After Burn

Not Applicable

Terminated

• Conditions: Post-burn Innervation
• Interventions: Procedure: Skin biopsy

• Registration Number: NCT02356354
• Lead Sponsor: University Hospital, Brest

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Study Start: 2015-08
• Primary Completion: 2016-08
• Status Verified: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of the differences of expression of genes coding for regulating proteins of the innervation	6 months	To evaluate the differences of expression of genes coding for regulating proteins of the innervation on samples of healthy skins and post-burn scar. These biopsies will be removed from post-burn patients (at least one year after burn) and allowing the comparison between conflicting dermatomes: a healthy dermatome and a formerly burned dermatome

Secondary Outcome Measures

Name	Time	Method
Validation of the difference of density of intra-epidermic nerve fibers	6 months	To validate the existence of a difference of density of intra-epidermal nerve fibers between the healthy skins and the post-burn scar.

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France