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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02089490
Recruitment Status : Unknown
Verified March 2014 by Symatese.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Third-degree Burns Reconstructive Surgery Device: NEVELIA® implantation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Assessment of the type and frequency of complications related to NEVELIA® [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Take rate of NEVELIA® [ Time Frame: At Day 21 ]
  2. Take rate of skin graft [ Time Frame: At Day 28, 6 and 12 months ]
  3. Satisfaction rate of physician and patient [ Time Frame: At 6 and 12 months ]
  4. Quality of healed skin [ Time Frame: At 6 and 12 months ]
    Vancouver score

  5. Re-operation rate [ Time Frame: At 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02089490

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Contact: Sophie AMAT-JARLIER +33478567280
Contact: Chantal BELIN +33478567280

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Centre François Xavier Michelet - CHU de Bordeaux
Bordeaux, France, 33076
Contact: Vincent Casoli, MD PhD    +33556795591   
Principal Investigator: Vincent Casoli, MD PhD         
Sponsors and Collaborators
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Principal Investigator: Vincent Casoli, MD PhD Centre François Xavier Michelet - CHU de Bordeaux, FRANCE
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Responsible Party: Symatese Identifier: NCT02089490    
Other Study ID Numbers: MCS2 NEVELIA
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Wounds and Injuries