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

Phase 2

Terminated

• Conditions: Burns
• Interventions: Drug: Dermal substrate cellularised LG002 (10x10cm); Device: Dermal substrate uncellularised LG002 (10x10 cm)

• Registration Number: NCT00366041
• Lead Sponsor: Laboratoires Genévrier

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 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-08-17
• Study First Submitted QC: 2006-08-17
• Study First Posted: 2006-08-18
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-20
• Last Update Posted: 2010-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cellularised LG002	Dermal substrate cellularised LG002 (10x10cm)	Cellularised LG002
UnCellularised LG002	Dermal substrate uncellularised LG002 (10x10 cm)	UnCellularised LG002

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Short and medium term: Percentage of take of thin skin autografts 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	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	each application
Supplementary parameter: Allogenic fibroblasts survival : chimerism study with biopsy (1 and 6 months)	1 and 6 months

Trial Locations

Locations (2)

Hôpital Cochin, Service des Brûlés; 🇫🇷 Paris, France

Hôpital d' Instruction des Armées de Percy, Service des Brûlés; 🇫🇷 Clamart, France