Clinical Research Directory
Browse clinical research sites, groups, and studies.
Dural Medical Adhesive for Watertight Sealing in Dural Repair
Sponsor: Medprin Regenerative Medical Technologies Co., Ltd.
Summary
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.
Official title: A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
141
Start Date
2024-05-29
Completion Date
2025-07-28
Last Updated
2026-08-10
Healthy Volunteers
No
Interventions
Dural medical adhesive
After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, evenly coat the adhesive over the sutured area. After curing, use Valsalva maneuver or hemostatic sponge test to check sealing effect. One repeated application is permitted if leakage persists. Postoperative drainage and unified follow-up schedule are performed.
Standard dural reinforcement surgery
After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, adopt conventional clinical reinforcement methods including autologous fat/fascia/muscle graft or supplementary suturing, without using any dural sealing adhesive products. Intraoperative sealing verification and postoperative follow-up schedule are identical to the experimental group.
Locations (6)
Peking University Third Hospital
Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Shenzhen Second People's Hospital
Shenzhen, China
Xi'an Honghui Hospital
Xi'an, China