A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 6
- 主要终点
- Intraoperative Watertight Sealing Success Rate
研究概览
简要总结
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage. A total of 141 patients with intraoperative CSF leakage after primary dural repair from 7 medical centers will be enrolled at a 2:1 randomization ratio (94 in adhesive group, 47 in standard treatment control group). Intraoperative watertight sealing success rate is the primary outcome. Postoperative CSF leakage rate at day 10±5 and day 90±7, drainage volume/duration, and adverse events/serious adverse events within 90 days are secondary outcomes to evaluate the safety and effectiveness of the investigational device.
详细描述
The investigational product is dural medical adhesive indicated for watertight sealing of dural defects in spinal surgery to prevent CSF leakage. This superiority trial adopts a prospective, multicenter, single-blind, randomized controlled design with 7 participating neurosurgical centers across China. Eligible patients are adults with visible CSF leakage after one-layer primary dural repair confirmed by intraoperative visualization, Valsalva maneuver or hemostatic sponge test. Subjects are randomly assigned 2:1 via sealed envelopes to two groups.
Intervention group: standard primary dural repair + dural medical adhesive evenly coated on the repair site for instant watertight sealing; a second application is allowed if persistent leakage occurs after first use.
Control group: standard treatment including autologous fat/fascia/muscle graft or reinforced suture after primary repair without medical adhesive.
All participants receive follow-up at postoperative day 10±5 (Visit 1) and day 90±7 (Visit 2). Primary efficacy endpoint is intraoperative successful watertight sealing without CSF leakage. Secondary endpoints include postoperative CSF leakage incidence at two time points, postoperative drainage volume and indwelling duration, and overall safety profiles including all adverse events and serious adverse events within 90 days post-operation. Statistical analyses will be performed on Full Analysis Set (FAS) and Per Protocol Set (PPS) for efficacy, and Safety Set (SS) for safety evaluation.
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
- 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
- •Aged 18-75 years old, any gender.
- •Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair.
- •Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test.
- •Patient or legal guardian voluntarily signs written informed consent form.
排除标准
- •Participated in another interventional clinical trial within 1 month before surgery.
- •Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery.
- •Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride).
- •History of severe anaphylaxis or immunodeficiency disorders.
- •Expected survival less than 3 months post-operation.
- •Pregnant, lactating female or women planning pregnancy within 3 months after surgery.
- •Poor treatment compliance judged by investigator, unable to complete full follow-up visits.
- •Unable to understand trial information and cooperate with assessment.
- •Intraoperative dural defect that cannot receive primary sutured repair.
- •Class III contaminated surgical wound or active infection at operation site.
- •Any other condition judged inappropriate for trial participation by investigator.
研究组 & 干预措施
Dural Medical Adhesive Treatment Group
After routine primary suture repair of spinal dural defects and intraoperative confirmation of cerebrospinal fluid leakage, evenly apply the investigational dural medical adhesive to the sutured repair area. After the adhesive is fully cured, perform Valsalva maneuver / hemostatic sponge test to recheck watertight sealing status. One additional application of the adhesive is permitted if leakage persists after the first application. Postoperative routine drainage and standardized follow-up are implemented.
干预措施: Dural medical adhesive (Device)
Standard Conventional Treatment Control Group
After routine primary suture repair of spinal dural defects with confirmed intraoperative cerebrospinal fluid leakage, adopt clinically conventional reinforcement measures: autologous fat/fascia/muscle transplantation or supplementary interrupted suturing for leak blocking, without using any dural sealing adhesive products. Recheck sealing effect intraoperatively by Valsalva maneuver / hemostatic sponge test, followed by postoperative routine drainage and identical follow-up schedule as the experimental group.
干预措施: Standard dural reinforcement surgery (Procedure)
结局指标
主要结局
Intraoperative Watertight Sealing Success Rate
时间窗: Intraoperatively (Visit 0)
Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
次要结局
- Postoperative CSF Leakage Rate at Day 10±5(Postoperative day 10±5 (Visit 1))
- Postoperative CSF Leakage Rate at Day 90±7(Postoperative day 90±7 (Visit 2))
- Postoperative Drainage Volume and Drain Indwelling Duration(Postoperative day 10±5 (Visit 1))
- Incidence of All Adverse Events and Serious Adverse Events(From surgery to postoperative day 90±7)