SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 15
- 主要终点
- Percentage of graft take of all SASS (Phase A+B)
研究概览
简要总结
This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deep second degree burns or third degree burns over 50% TBSA (Total body surface area) at time of recruitment or as determined by the surgeon;
- •Limited availability of donor sites for autografts;
- •Consent obtained by the participant or by the appropriate representative in case of inapt prospective participants or minors.
排除标准
- •Skin grafting needed only on the face, hands, feet, ears or genital area;
- •Connective tissue diseases;
- •Hypersensitivity to bovine proteins;
- •Coagulation disorders prior being burned;
- •Immunodeficiency prior being burned;
- •Uncontrolled diabetes prior being burned;
- •Permanent wound coverage before SASS grafts are ready;
研究组 & 干预措施
Treatment (SASS)
Phase A: All patients will receive both Self assembled skin substitute (SASS) and Split-thickness autograft (paired samples sites A+ B). // Phase B: All patients will receive Self assembled skin subsitute (SASS)
干预措施: Self assembled skin substitute (SASS) (Biological)
结局指标
主要结局
Percentage of graft take of all SASS (Phase A+B)
时间窗: < 1 month
Clinical assessment
Percentage of graft take site A vs site B (Phase A 17 patients)
时间窗: < 1 month
Clinical assessment; Image analysis
Percentage of graft take according to sites (Phase A+B)
时间窗: < 1 month
Clinical assessment
次要结局
- Scar evaluation site A vs site B (Phase A 17 patients)(3, 6, 12, 24 and 36 months)
- Scar evaluation according to sites (Phase A+B)(3, 6, 12, 24 and 36 months)
- Incidence of adverse events site A vs site B (Phase A 17 patients)(24 to 36 months)
- Incidence of adverse events of all SASS (Phase A+B)(24 to 36 months)
- Quality of life survey (Phase A+B)(3, 6, 12, 24 and 36 months)
- Ratio harvested surface vs covered surface (Phase A+B)(1 month)
研究者
Veronique Moulin
Researcher
CHU de Quebec-Universite Laval