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

January 20, 2010 updated by: Laboratoires Genévrier

Multicentre Clinical Study to Compare the Efficacy and the Tolerance of Cellularised LG002 With the Efficacy and Tolerance of Uncellularised LG002 in the Treatment of Severe Burn Injury

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

For lesions that cannot heal spontaneously, the wound is excised until fascia. Four contiguous dermal substrates (uncellularised and cellularised) are randomly grafted on each symmetric area.

A primary siliconized dressing will cover the wound. Secondary dressing: dressing gauze impregnated with physiologic serum and/or sterile dried dressing gauze, the whole is maintained by a (slightly compressive) tubular or elastic bandage.

Thin skin meshed autograft will occur 14 to 21 days after dermal substrate cellularised LG002 or uncellularised LG002 grafting (time frame necessary for the site to vascularize).

Meshed autograft development must be identical in both symmetric areas, for one single patient.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • Hôpital d' Instruction des Armées de Percy, Service des Brûlés
      • Paris, France, 75679
        • Hôpital Cochin, Service des Brûlés

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with severe burn injuries ≥ 40 % of TBSA (Total Body Surface Area)
  • Thermal burn on symmetrical areas allowing grafting of 4 contiguous dermal substrates (cellularised LG002 or uncellularised LG002) on each area
  • The patient himself, or his legal representative, must give his informed consent in writing

Exclusion Criteria:

  • Anterior progressive serious illness (i.e severe hepatic insufficiency, immunodepression induced by corticotherapy or illness (AIDS))
  • Metabolic disease
  • Systemic infection or local burn infection
  • Known allergy to collagen, streptomycin, Penicillin and/or bovine origine products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cellularised LG002
Drug: Dermal substrate cellularised LG002 (10x10cm)
application depending on burn injury surface
Experimental: UnCellularised LG002
Device: Dermal substrate uncellularised LG002 (10x10 cm)
depending on burn injury surface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)
Time Frame: 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002
6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002

Secondary Outcome Measures

Outcome Measure
Time Frame
Short and medium term: Percentage of take of thin skin autografts 12 and 30 days after their application
Time Frame: 12 and 30 days after their application
12 and 30 days after their application
Long term: Clinical evaluation (Vancouver scale 1, 3, 6, 12 months) and histological evaluation (3mm biopsy) to investigate the dermal-epidermal junction and the extra-cellular matrix (1 and 6 month) in order to evaluate the scar quality
Time Frame: 1, 3, 6, 12 months
1, 3, 6, 12 months
Tolerance parameter: Investigator's global judgement, post grafting infection (swabbing during each new dressing for staphylococcus aureus detection), adverse event for intolerance
Time Frame: each application
each application
Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)
Time Frame: 1 and 6 months
1 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Genévrier

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Hôpital d'Instruction des Armées de Percy

Investigators

  • Study Chair: Christine DOSQUET, MD, Hôpital Saint Louis, Unité thérapie cellulaire et Unité INSERM 553
  • Principal Investigator: Daniel WASSERMANN, PhD, MD, Hôpital Cochin, Service des Brûlés

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (Estimate)

August 18, 2006

Study Record Updates

Last Update Posted (Estimate)

January 21, 2010

Last Update Submitted That Met QC Criteria

January 20, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03F/DE01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burns

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe