Study of the Cutaneous Reinnervation After Burn

NCT02356354 | Terminated DMC

• 1 other identifier: RB 14.190 NERVAL
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-burn Innervation

Keywords

molecular factors; cutaneous innervation; skin biopsy; post-burn scar

Outcome Measures

Primary Outcomes (1)

• Number of the differences of expression of genes coding for regulating proteins of the innervation

  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

  6 months

Secondary Outcomes (1)

• Validation of the difference of density of intra-epidermic nerve fibers

  6 months

Study Arms (1)

Skin biopsy

OTHER

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

Procedure: Skin biopsy

Interventions

Skin biopsy PROCEDURE

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

Skin biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, France, 29609, France

Location

Study Officials

• Laurent MISERY

  CHRU de Brest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 5, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

FR (1)