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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Drug: Dermal substrate cellularised LG002 (10x10cm)
* Device: Dermal substrate uncellularised LG002 (10x10 cm)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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) |  | 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |