NCT02089490

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Symatese · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Third-degree Burns
• Reconstructive Surgery

Interventions

Type	Name	Description
DEVICE	NEVELIA® implantation	Skin substitute implantation followed by ultra-thin epidermal graft

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2014-03-17
• Last updated: 2014-03-17

Locations

1 site across 1 country: France