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

NCT02089490 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-03-17

No results posted yet for this study

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.

Conditions

  • Third-degree Burns
  • Reconstructive Surgery

Interventions

DEVICE

NEVELIA® implantation

Skin substitute implantation followed by ultra-thin epidermal graft

Sponsors & Collaborators

  • Symatese

    lead INDUSTRY

Principal Investigators

  • Vincent Casoli, MD PhD · Centre François Xavier Michelet - CHU de Bordeaux, FRANCE

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-01-31
Completion
2016-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02089490 on ClinicalTrials.gov