TerminatedNot Applicable

Study of the Cutaneous Reinnervation After Burn

Stopped: Difficulty to recruit all the patients

France6 participantsStarted 2015-08

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months

Trial details

NCT IDNCT02356354

SponsorUniversity Hospital, Brest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

View on ClinicalTrials.gov More Post-burn Innervation trials