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

Laboratoires Genévrier

Status and phase: Terminated; Phase 2

Conditions: Burns

Treatments: Drug: Dermal substrate cellularised LG002 (10x10cm); Device: Dermal substrate uncellularised LG002 (10x10 cm)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00366041

03F/DE01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Cellularised LG002

Experimental group

Description:

Cellularised LG002

Treatment:

Drug: Dermal substrate cellularised LG002 (10x10cm)

UnCellularised LG002

Experimental group

Description:

UnCellularised LG002

Treatment:

Device: Dermal substrate uncellularised LG002 (10x10 cm)