NCT01174992已完成2 期
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 24
- 主要终点
- Proportion of success
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.
详细描述
This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective craniotomy/craniectomy
- •Age greater than or equal to 18 years
- •Patients who are able and willing to comply with the procedures required by the protocol.
- •Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.
排除标准
- •Chemotherapy or radiation therapy within 7 days following surgery.
- •Conditions compromising the immune system.
- •Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
- •Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
- •Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
- •Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
- •Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.
结局指标
主要结局
Proportion of success
时间窗: Day 1 (intraoperative)
Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.
次要结局
- Incidence of CSF leakage(Day 30 post-op)
- Incidence of adverse events(up to 30 days post-op)
- Incidence of surgical site infections(Day 5 and 30 post-op)
研究者
研究点 (24)
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