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

Symatese

Status: Unknown

Conditions: Third-degree Burns; Reconstructive Surgery

Treatments: Device: NEVELIA® implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089490

MCS2 NEVELIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

NEVELIA®

Experimental group

Description:

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

Treatment:

Device: NEVELIA® implantation