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

NCT ID: NCT02089490

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Third-degree Burns; Reconstructive Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NEVELIA®

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

Group Type: EXPERIMENTAL

NEVELIA® implantation

Intervention Type: DEVICE

Skin substitute implantation followed by ultra-thin epidermal graft

Interventions

NEVELIA® implantation

Skin substitute implantation followed by ultra-thin epidermal graft

Intervention Type: DEVICE

Other Intervention Names

Skin substitute graft; Skin substitute placement

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Symatese

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Casoli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre François Xavier Michelet - CHU de Bordeaux, FRANCE

Locations

Centre François Xavier Michelet - CHU de Bordeaux

Bordeaux, , France

Countries

France

Central Contacts

Sophie AMAT-JARLIER

Role: CONTACT

s.amatjarlier@symatese.com

+33478567280

Chantal BELIN

Role: CONTACT

c.belin@symatese.com

+33478567280

Facility Contacts

Vincent Casoli, MD PhD

Role: primary

vincent.casoli@chu-bordeaux.fr

+33556795591

References

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.

Reference Type: BACKGROUND

PMID: 19864266 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17435787 (View on PubMed)

MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. doi: 10.1038/nature05664.

Reference Type: BACKGROUND

PMID: 17314974 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17825993 (View on PubMed)

Koenen W, Felcht M, Goerdt S, Faulhaber J. Skin substitutes in dermatosurgery. G Ital Dermatol Venereol. 2010 Oct;145(5):637-49.

Reference Type: BACKGROUND

PMID: 20930698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20116939 (View on PubMed)

Other Identifiers

MCS2 NEVELIA

Identifier Type: -

Identifier Source: org_study_id