NCT02089490

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

March 14, 2014

Last Update Submit

March 14, 2014

Conditions

Third-degree BurnsReconstructive Surgery

Outcome Measures

Primary Outcomes (1)

  • Assessment of the type and frequency of complications related to NEVELIA®

    Up to 12 months

Secondary Outcomes (5)

  • 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

    At 6 and 12 months

  • Re-operation rate

    At 12 months

Study Arms (1)

NEVELIA®

EXPERIMENTAL

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

Device: NEVELIA® implantation

Interventions

NEVELIA® implantationDEVICE

Skin substitute implantation followed by ultra-thin epidermal graft

Also known as: Skin substitute graft, Skin substitute placement
NEVELIA®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François Xavier Michelet - CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (6)

  • 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.

    PMID: 19864266BACKGROUND

  • 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.

    PMID: 17435787BACKGROUND

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

    PMID: 17314974BACKGROUND

  • 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.

    PMID: 17825993BACKGROUND

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

    PMID: 20930698BACKGROUND

  • 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.

    PMID: 20116939BACKGROUND

Study Officials

  • Vincent Casoli, MD PhD

    Centre François Xavier Michelet - CHU de Bordeaux, FRANCE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie AMAT-JARLIER

CONTACT

+33478567280s.amatjarlier@symatese.com

Chantal BELIN

CONTACT

+33478567280c.belin@symatese.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

FR(1)