NCT04086550已完成不适用
Randomized, Two-arm, Multicenter Study to Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
Polyganics BV26 个研究点 分布在 7 个国家目标入组 228 人开始时间: 2021年5月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 26
- 主要终点
- Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection
研究概览
简要总结
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.
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
- •pre-operative
- •Subjects who are able to provide written informed consent prior to participating in the clinical investigation.
- •Subjects who are ≥ 18 years old.
- •Subjects who are able to comply with the follow-up or other study requirements.
- •Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed.
- •Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery.
- •intra-operative
- •Subjects with surgical wound classification Class I/Clean.
- •Subjects with minimally 5 mm of dural space surrounding dural opening.
排除标准
- •pre-operative
- •Female subjects who are pregnant or breastfeeding.
- •Subjects with an assumed impaired coagulation due to medication or otherwise.
- •Subjects suspected of an infection requiring antibiotics.
- •Subjects with any type of dural diseases in planned dural closure area.
- •Subjects requiring re-opening of planned surgical area within 90 days after surgery.
- •Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®.
- •Subjects who previously received a LIQOSEAL®.
- •Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening.
- •Subjects with a presence of hydrocephalus.
- •Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement].
- •intra-operative
- •Subjects in whom elevation of PEEP has a potential detrimental effect.
- •Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery.
- •Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea.
- •Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP.
- •Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm.
- •Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
结局指标
主要结局
Composite endpoint defined as successful dural repair without any of the following compared to the control group: intra-operative CSF leakage percutaneous CSF leak significant pseudomeningocele wound infection
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (26)
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