Post-burn Innervation Clinical Trial
— NERVALOfficial title:
Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing
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.
| Status | Terminated |
| Enrollment | 6 |
| Est. completion date | September 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Brest | Brest |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Validation of the difference of density of intra-epidermic nerve fibers | To validate the existence of a difference of density of intra-epidermal nerve fibers between the healthy skins and the post-burn scar. | 6 months | No |