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

Reconstructive Surgery Clinical Trial

— NEVAL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02089490
• Other study ID #: MCS2 NEVELIA
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 14, 2014
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2014
• Source: Symatese
• Contact: Sophie AMAT-JARLIER
• Phone: +33478567280
• Email: s.amatjarlier[@]symatese.com
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life Sciences
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Reconstructive Surgery
• Third-degree Burns

Intervention

Device:
• NEVELIA® implantation
Skin substitute implantation followed by ultra-thin epidermal graft

Locations

Country	Name	City	State
France	Centre François Xavier Michelet - CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Symatese

Country where clinical trial is conducted

France, 

References & Publications (6)

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. Review. French. — View Citation

Clark RA, Ghosh K, Tonnesen MG. Tissue engineering for cutaneous wounds. J Invest Dermatol. 2007 May;127(5):1018-29. Review. — View Citation

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

MacNeil S. Progress and opportunities for tissue-engineered skin. Nature. 2007 Feb 22;445(7130):874-80. Review. — View Citation

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. Epub 2007 Sep 7. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the type and frequency of complications related to NEVELIA®		Up to 12 months	Yes
Secondary	Take rate of NEVELIA®		At Day 21	No
Secondary	Take rate of skin graft		At Day 28, 6 and 12 months	No
Secondary	Satisfaction rate of physician and patient		At 6 and 12 months	No
Secondary	Quality of healed skin	Vancouver score	At 6 and 12 months	No
Secondary	Re-operation rate		At 12 months	No