Post-burn InnervationNERVALNCT02356354
Study of the Cutaneous Reinnervation After Burn
A study testing Skin biopsy in people with Post-burn Innervation, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-burn Innervation
- What is being tested?
- Skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
- Conditions
- Post-burn Innervation
- Being tested
- Skin biopsy
- Keywords
- molecular factors, cutaneous innervation, skin biopsy, post-burn scar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or surgery
2 biopsies are done on the same patient : 20 cutaneous biopsies from post-burn scar and from healthy skin
| Study group | Role | What they receive |
|---|---|---|
| Skin biopsy | Other | On the same patient, a biopsy of post-burn scar is removed. A second one is removed from healthy skin. Receives: Procedure: Skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionSep 2016
Why it stopped: Difficulty to recruit all the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-burn InnervationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MISERY, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356354
- Sponsor's protocol ID
- RB 14.190 NERVAL
- Acronym
- NERVAL
- Status last verified
- Sep 2016
- First submitted
- 26 Jan 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Cutaneous Reinnervation After Burn With the Aim of a Better Care of Neuropathic Pain and Pruritus After Healing
- ClinicalTrials.gov ID
- NCT02356354
- Acronym / sponsor ID
- NERVAL / RB 14.190 NERVAL
- Conditions
- Post-burn Innervation
- Keywords
- molecular factors, cutaneous innervation, skin biopsy, post-burn scar
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty to recruit all the patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin biopsy | Other | Procedure: Skin biopsyOn the same patient, a biopsy of post-burn scar is removed. A second one is removed from healthy skin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsy2 biopsies are done on the same patient : 20 cutaneous biopsies from post-burn scar and from healthy skin | Procedure or surgery | Skin biopsy |
Primary outcome
Number of the differences of expression of genes coding for regulating proteins of the innervation
Time frame: 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
1 secondary outcome
Validation of the difference of density of intra-epidermic nerve fibers
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Difficulty to recruit all the patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent MISERY principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy in people with Post-burn Innervation, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty to recruit all the patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the differences of expression of genes coding for regulating proteins of the innervation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2016.