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

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

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.

Study Overview

• Status: Unknown
• Conditions: Third-degree Burns; Reconstructive Surgery
• Intervention / Treatment: Device: NEVELIA® implantation

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Centre François Xavier Michelet - CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the type and frequency of complications related to NEVELIA®	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Vancouver score	At 6 and 12 months
Re-operation rate		At 12 months

Collaborators and Investigators

• Sponsor: Symatese
• Investigators: Principal Investigator: Vincent Casoli, MD PhD, Centre François Xavier Michelet - CHU de Bordeaux, FRANCE

Publications and helpful links

General Publications

• Shevchenko RV, James SL, James SE. A review of tissue-engineered skin bioconstructs available for skin reconstruction. J R Soc Interface. 2010 Feb 6;7(43):229-58. doi: 10.1098/rsif.2009.0403. Epub 2009 Oct 28.
• Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. doi: 10.1038/sj.jid.5700715.
• MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. doi: 10.1038/nature05664.
• Pham C, Greenwood J, Cleland H, Woodruff P, Maddern G. Bioengineered skin substitutes for the management of burns: a systematic review. Burns. 2007 Dec;33(8):946-57. doi: 10.1016/j.burns.2007.03.020. Epub 2007 Sep 7.
• Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.
• Chaouat M, Zakine G, Mimoun M. [Principles of the local treatment: Surgical processing]. Pathol Biol (Paris). 2011 Jun;59(3):e57-61. doi: 10.1016/j.patbio.2009.12.003. Epub 2010 Feb 8. French.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2014
• Last Update Submitted That Met QC Criteria: March 14, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MCS2 NEVELIA