NCT00371215已完成2 期
A Phase 2 Study of Recombinant Human Thrombin (rThrombin) Administered Using a Spray Applicator in Subjects Undergoing Autologous Skin Grafting Following Burn or Traumatic Skin Injury
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ZymoGenetics
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
详细描述
This is a Phase 2 multiple site, single-arm, open-label study designed to evaluate the safety of rThrombin in subjects of age 2 to 75 years who are receiving a partial- or full-thickness autologous sheet or mesh grafts following burn or traumatic skin injury. After establishing eligibility, study participants will be treated with topical spray rThrombin at the skin graft recipient site during autologous skin graft surgery. There will be a 1-month follow-up period after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autologous skin grafting with sheet or mesh grafts following burn or traumatic skin injury
排除标准
- •Known antibodies or hypersensitivity to thrombin or other coagulation factors
研究组 & 干预措施
1
Experimental
rThrombin
干预措施: rThrombin (Biological)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: Up to day 29
次要结局
- The incidence and grade of clinical laboratory abnormalities(Up to day 29)
- The incidence of anti-rThrombin product antibodies(Up to day 29)
- The incidence of hemostasis(Up to 20 minutes)
- The percentage of graft take(Up to day 29)
- The incidence of re-grafting(Up to day 29)
研究者
研究点 (1)
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