Evaluation of NEVELIA® in Terms of Safety and Efficacy for Third-degree Burns Treatment or Reconstructive Surgery (NEVAL)
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Assessment of the type and frequency of complications related to NEVELIA® [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
- Take rate of NEVELIA® [ Time Frame: At Day 21 ] [ Designated as safety issue: No ]
- Take rate of skin graft [ Time Frame: At Day 28, 6 and 12 months ] [ Designated as safety issue: No ]
- Satisfaction rate of physician and patient [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]
- Quality of healed skin [ Time Frame: At 6 and 12 months ] [ Designated as safety issue: No ]Vancouver score
- Re-operation rate [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
NEVELIA® implantation according to the intended use in the leaflet, prior to autologous skin grafting planned 3 weeks after its application.
Device: NEVELIA® implantation
Skin substitute implantation followed by ultra-thin epidermal graft
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02089490
|Contact: Sophie AMAT-JARLIERfirstname.lastname@example.org|
|Contact: Chantal BELINemail@example.com|
|Centre François Xavier Michelet - CHU de Bordeaux||Not yet recruiting|
|Bordeaux, France, 33076|
|Contact: Vincent Casoli, MD PhD +33556795591 firstname.lastname@example.org|
|Principal Investigator: Vincent Casoli, MD PhD|
|Principal Investigator:||Vincent Casoli, MD PhD||Centre François Xavier Michelet - CHU de Bordeaux, FRANCE|