A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- surgical successful rate
研究概览
简要总结
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision.
- •Dural defects and surgical incision was classifed as level 1
排除标准
- •local or systemic infection.
- •patients with known allergy to Equipment components
- •a history of traumatic head injury
- •a compromised immune system or autoimmune disease
- •patients who should not participate based on the surgeon's opinion
- •patients participating in any other drug or device trial.
- •expected survival time <12 months
- •underwent chemoradiotherapy 3 months before randomization
- •uncontrolled diabetes and malignant tumor
- •women who were pregnant, lactating, or wished to become pregnant during the study;
结局指标
主要结局
surgical successful rate
时间窗: at 30 days post surgery
proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.
次要结局
- neurosurgical complication(2 days post surgery/10 days post surgery/at 30 days post surgery)