Third-degree BurnsNEVALNCT02089490
Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery
A study testing NEVELIA® implantation in people with Third-degree Burns and Reconstructive Surgery, run by Symatese at 1 site in France.
Trial summary
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third-degree Burns, Reconstructive Surgery
- What is being tested?
- NEVELIA® implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Apr 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
- Patients aged 18 or older
- Patient geographically stable,
- Patient requiring dermal reconstruction after third-degree burns, reconstructive surgery or trauma surgery;
- Patient who signed the non-opposition form;
- Patient able to be followed up to 12 months.
Who cannot join
- Patient with clinical signs of wound infection;
- Allergic patient or with known allergy to bovine collagen or silicone;
- Patient with life-threatening conditions;
- Patient receiving a treatment that may affect wound healing;
- Patient with an autoimmune or immunosuppressive disease;
- Patient with a suspected neurological disease as Creutzfeldt-Jakob disease;
- Patient simultaneously participating in another study;
- Pregnant or nursing woman.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre François Xavier Michelet - CHU de Bordeaux
Bordeaux, 33076
Vincent Casoli, MD PhD, +33556795591, vincent.casoli@chu-bordeaux.fr
Vincent Casoli, MD PhD
About this study
Official title: Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery
The dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.
The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.
Read the detailed description
The NEVAL protocol is a descriptive study conducted in order to confirm the clinical evidence of safety and performance of NEVELIA®, as described in the literature on equivalent products.
This dermal substitute consists of an inner biodegradable dermal substitute made of bovine collagen (collagen of type I), covered with an outer silicone membrane. Its porosity and the speed of degradation allow the act of recolonization by the fibroblasts and initiation of the vascularization process within 3 weeks. The application procedure requires removement of the silicone layer and wound covering with an ultra-thin epidermal graft, possibly meshed. This surgical procedure is well-known and permits an ultra-thin epidermal graft.
All the patients will be treated with NEVELIA®, prior to autologous skin grafting within 3 weeks after its application. Then, three follow-up visits will be planned: post operatively, at 6 and 12 months.
The objectives are:
- Primary objective: To assess the type and frequency of complications
- Secondary objectives:
- To assess the take rate of NEVELIA®
- To assess the take rate of skin graft
- To assess the satisfaction rate of physician and patient,
- To assess the quality of the healed skin,
- To assess the rate of re-operation at 12 months.
- Conditions
- Third-degree Burns, Reconstructive Surgery
- Being tested
- NEVELIA® implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEVELIA® implantationDevice
Also called Skin substitute graft, Skin substitute placement
Skin substitute implantation followed by ultra-thin epidermal graft
| Study group | Role | What they receive |
|---|---|---|
| NEVELIA® | Experimental | NEVELIA® implantation according to the intended use in the leaflet, prior to autologous skin grafting planned 3 weeks after its application. Receives: Device: NEVELIA® implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the type and frequency of complications related to NEVELIA®
Measured: Up to 12 months
Secondary outcomes (5)
Take rate of NEVELIA®
Measured: At Day 21
Take rate of skin graft
Measured: At Day 28, 6 and 12 months
Satisfaction rate of physician and patient
Measured: At 6 and 12 months
Quality of healed skin
Vancouver score
Measured: At 6 and 12 months
Re-operation rate
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Third-degree BurnsStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Symatese
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vincent Casoli, MD PhD, Principal investigator, Centre François Xavier Michelet - CHU de Bordeaux, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089490
- Sponsor's protocol ID
- MCS2 NEVELIA
- Acronym
- NEVAL
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28.
PubMed 19864266Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. doi: 10.1038/sj.jid.5700715.
PubMed 17435787MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. doi: 10.1038/nature05664.
PubMed 17314974Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. doi: 10.1016/j.burns.2007.03.020. Epub 2007 Sep 7.
PubMed 17825993Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.
PubMed 20930698Chaouat M, Zakine G, Mimoun M. [Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. French.
PubMed 20116939
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Follow-up Study for the Evaluation of the Safety and Efficacy of the Dermal Substitute NEVELIA® in the Treatment of Third-degree Burns and Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT02089490
- Acronym / sponsor ID
- NEVAL / MCS2 NEVELIA
- Conditions
- Third-degree Burns, Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- SymateseIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 17 Mar 2014 (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 dermal substitute NEVELIA® has received CE marking in July 9, 2013. Its use in the NEVAL protocol will be in accordance with its leaflet, i.e. for the treatment of burns or in case of reconstructive plastic surgery.
The matric implantation will be followed by autologous skin grafting when the neodermis formation will be observed.
Detailed description
The NEVAL protocol is a descriptive study conducted in order to confirm the clinical evidence of safety and performance of NEVELIA®, as described in the literature on equivalent products.
This dermal substitute consists of an inner biodegradable dermal substitute made of bovine collagen (collagen of type I), covered with an outer silicone membrane. Its porosity and the speed of degradation allow the act of recolonization by the fibroblasts and initiation of the vascularization process within 3 weeks. The application procedure requires removement of the silicone layer and wound covering with an ultra-thin epidermal graft, possibly meshed. This surgical procedure is well-known and permits an ultra-thin epidermal graft.
All the patients will be treated with NEVELIA®, prior to autologous skin grafting within 3 weeks after its application. Then, three follow-up visits will be planned: post operatively, at 6 and 12 months.
The objectives are:
- Primary objective: To assess the type and frequency of complications
- Secondary objectives:
- To assess the take rate of NEVELIA®
- To assess the take rate of skin graft
- To assess the satisfaction rate of physician and patient,
- To assess the quality of the healed skin,
- To assess the rate of re-operation at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEVELIA® | Experimental | Device: NEVELIA® implantationNEVELIA® implantation according to the intended use in the leaflet, prior to autologous skin grafting planned 3 weeks after its application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 or older
- Patient geographically stable,
- Patient requiring dermal reconstruction after third-degree burns, reconstructive surgery or trauma surgery;
- Patient who signed the non-opposition form;
- Patient able to be followed up to 12 months.
Key exclusion criteria (8 listed)
- Patient with clinical signs of wound infection;
- Allergic patient or with known allergy to bovine collagen or silicone;
- Patient with life-threatening conditions;
- Patient receiving a treatment that may affect wound healing;
- Patient with an autoimmune or immunosuppressive disease;
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 |
|---|---|---|
| NEVELIA® implantationAlso: Skin substitute graft, Skin substitute placementSkin substitute implantation followed by ultra-thin epidermal graft | Device | NEVELIA® |
Primary outcome
Assessment of the type and frequency of complications related to NEVELIA®
Time frame: Up to 12 months
5 secondary outcomes
Take rate of NEVELIA®
Time frame: At Day 21
Take rate of skin graft
Time frame: At Day 28, 6 and 12 months
Satisfaction rate of physician and patient
Time frame: At 6 and 12 months
Quality of healed skin
Time frame: At 6 and 12 months
Re-operation rate
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Background: PubMed 19864266Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28.
- Background: PubMed 17435787Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. doi: 10.1038/sj.jid.5700715.
- Background: PubMed 17314974MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. doi: 10.1038/nature05664.
- Background: PubMed 17825993Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. doi: 10.1016/j.burns.2007.03.020. Epub 2007 Sep 7.
- Background: PubMed 20930698Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.
- Background: PubMed 20116939Chaouat M, Zakine G, Mimoun M. [Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. French.
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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.
Vincent Casoli, MD PhD principal investigator
Centre François Xavier Michelet - CHU de Bordeaux, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEVELIA® implantation in people with Third-degree Burns and Reconstructive Surgery, run by Symatese 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 17 Mar 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie AMAT-JARLIER (+33478567280, s.amatjarlier@symatese.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the type and frequency of complications related to NEVELIA® (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089490, which also lists 6 linked publications.
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 17 Mar 2014.