Study of the Cutaneous Reinnervation After Burn

Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02356354

Acronym

NERVAL

Enrollment

Registered

2015-02-05

Start date

2015-08-31

Completion date

2016-09-30

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-burn Innervation

Keywords

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

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.

Interventions

PROCEDURESkin biopsy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026