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

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Genévrier
• Collaborators: Hôpital d'Instruction des Armées de Percy; Institut National de la Santé Et de la Recherche Médicale, France

Criteria

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