Status:
TERMINATED
Efficacy and Tolerance of Cellularised LG002 Versus Uncellularised LG002 in the Treatment of Severe Burns Injuries
Lead Sponsor:
Laboratoires Genévrier
Collaborating Sponsors:
Hôpital d'Instruction des Armées de Percy
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Burns
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 repl...
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 prima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00366041
Start Date
February 1 2006
End Date
December 1 2009
Last Update
January 21 2010
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital d' Instruction des Armées de Percy, Service des Brûlés
Clamart, France, 92141
2
Hôpital Cochin, Service des Brûlés
Paris, France, 75679