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

Not Applicable

• Conditions: Third-degree Burns; Reconstructive Surgery
• Interventions: Device: NEVELIA® implantation

• Registration Number: NCT02089490
• Lead Sponsor: Symatese

Brief 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.

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Last Update Submitted: 2014-03-14
• Study First Posted: 2014-03-17
• Last Update Posted: 2014-03-17
• Study Start: 2014-04
• Primary Completion: 2016-01
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NEVELIA®	NEVELIA® implantation	NEVELIA® implantation according to the intended use in the leaflet, prior to autologous skin grafting planned 3 weeks after its application.

Primary Outcome Measures

Name	Time	Method
Assessment of the type and frequency of complications related to NEVELIA®	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
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	At 6 and 12 months	Vancouver score
Re-operation rate	At 12 months

Trial Locations

Locations (1)

Centre François Xavier Michelet - CHU de Bordeaux; 🇫🇷 Bordeaux, France