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Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries

NCT00366041 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-21

No results posted yet for this study

Summary

After severe burn injury, the full-thickness burn areas are excised (in the first week) and then temporarily covered with allograft (cryogenic preserved cadaver skin). This first covering is then replaced with thin skin meshed autograft.

In this study, either the dermal substrates cellularised LG002 or uncellularised LG002 will be grafted, after excision, in symmetrical areas, in replacement of the allografts. Fourteen to twenty one days after this first covering, the dermal substrate will be covered with thin skin meshed autograft.

Conditions

  • Burns

Interventions

DRUG

Dermal substrate cellularised LG002 (10x10cm)

application depending on burn injury surface

DEVICE

Dermal substrate uncellularised LG002 (10x10 cm)

depending on burn injury surface

Sponsors & Collaborators

  • Hôpital d'Instruction des Armées de Percy

    collaborator UNKNOWN

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Laboratoires Genévrier

    lead INDUSTRY

Principal Investigators

  • Christine DOSQUET, MD · Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553

  • Daniel WASSERMANN, PhD, MD · Hôpital Cochin, Service des Brûlés

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-12-31
Completion
2009-12-31

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 NCT00366041 on ClinicalTrials.gov