Efficacy of a Fibrin Sealant in Burn Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- initial wound hemostasis
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a fibrin glue in burn surgery with respect to hemostasis and skin graft fixation.
详细描述
Burn patients require extensive split-thickness skin grafting operations. These operations necessitate excision of burn wounds and the procurement of autografts. Both of these result in bleeding open wounds. Fibrin sealants may be of benefit in three aspects of burn surgery:
- as a hemostatic agent on excised burns,
- as a hemostatic agent on donor sites, and
- as a method of fixation of skin grafts to wounds.
Skin grafts are routinely secured with surgical staples. Patients with large burns will commonly have hundreds, even thousands of staples used during the course of their care. Problems associated with the use of surgical staples include:
- discomfort upon removal and
- staples become deeply embedded in the tissue.
If effective in securing skin grafts, fibrin glue would directly benefit burn patients by decreasing the number of staples required, and thereby decreasing the number of retained staples. Fibrin sealant is produced from human fibrinogen and human thrombin from pooled plasma that is virally inactivated by a two-stage heating process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Requires skin grafting of an acute or reconstructive burn wound.
排除标准
- •Active disseminated intravascular coagulation (DIC) or known hypersensitivity to bovine protein.
结局指标
主要结局
initial wound hemostasis
initial donor site hemostasis
initial graft fixation
percent graft take at 1 week
outcome and cosmetic appearance at routine intervals up to 24 months
次要结局
未报告次要终点
研究者
Robert L. Sheridan
Surgeon
Massachusetts General Hospital