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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Symatese
Sponsor:
Information provided by (Responsible Party):
Symatese
ClinicalTrials.gov Identifier:
NCT02089490
First received: March 14, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Third-degree Burns
Reconstructive Surgery
Device: NEVELIA® implantation

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Symatese:

Primary Outcome Measures:
  • Assessment of the type and frequency of complications related to NEVELIA® [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
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)
Arms Assigned Interventions
Experimental: NEVELIA®
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
Other Names:
  • Skin substitute graft
  • Skin substitute placement

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089490

Contacts
Contact: Sophie AMAT-JARLIER +33478567280 s.amatjarlier@symatese.com
Contact: Chantal BELIN +33478567280 c.belin@symatese.com

Locations
France
Centre François Xavier Michelet - CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Vincent Casoli, MD PhD    +33556795591    vincent.casoli@chu-bordeaux.fr   
Principal Investigator: Vincent Casoli, MD PhD         
Sponsors and Collaborators
Symatese
Investigators
Principal Investigator: Vincent Casoli, MD PhD Centre François Xavier Michelet - CHU de Bordeaux, FRANCE