Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- • To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection
研究概览
简要总结
The purpose of this study is to compare the rate of healing and the non-adherence of three types of dressings. The study will also compare rate of infection, scarring and perception of pain associated with treatment.
详细描述
The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for the treatment of donor sites in burn surgery.
Primary Study Goals:
-
To compare the rate of healing of donor sites.
-
To compare patient reported perception of pain
-
To compare the potential clinical complication rates of:
-
non-adherence,
-
seroma
-
hematoma
-
infection
Secondary Study Goal:
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Burn wounds measuring 1% - 30% TBSA requiring skin grafting
- •Anterior bilateral donor sites of approximately the same size taken from the thighs or abdomen
排除标准
- •Ventilator dependence
- •Pregnancy /Lactation
- •Mechanism of injury was electrical, chemical or frostbite
- •Co-morbidity which may compromise healing
- •Known allergy to porcine or porcine products
结局指标
主要结局
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection
时间窗: 2 year follow-up
次要结局
- • To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.(2 year follow-up)