Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Third-degree Burns, Reconstructive Surgery

Intervention / Treatment
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* Device: NEVELIA® implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEVELIA®<br>NEVELIA® implantation according to the intended use in the leaflet, prior to autologous skin grafting planned 3 weeks after its application. | Device: NEVELIA® implantation<br>* Skin substitute implantation followed by ultra-thin epidermal graft<br>* Other names: Skin substitute placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the type and frequency of complications related to NEVELIA® |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Take rate of NEVELIA® |  | At Day 21 | 
| Take rate of skin graft |  | At Day 28, 6 and 12 months | 
| Satisfaction rate of physician and patient |  | At 6 and 12 months | 
| Quality of healed skin | Vancouver score | At 6 and 12 months | 
| Re-operation rate |  | At 12 months |