Burns Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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