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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cellularised LG002
Cellularised LG002
干预措施: Dermal substrate cellularised LG002 (10x10cm) (Drug)
UnCellularised LG002
UnCellularised LG002
干预措施: Dermal substrate uncellularised LG002 (10x10 cm) (Device)
结局指标
主要结局
Percentage of take of thin skin autografts 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002 (visual assessment + photography)
时间窗: 6 days after their application on dermal substrate cellularised LG002 or uncellularised LG002
次要结局
- 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)