Dural Medical Adhesive for Watertight Sealing in Dural Repair

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.

NCT Number	NCT07754344
Lead Sponsor	Medprin Regenerative Medical Technologies Co., Ltd. Collaborators: Xuanwu Hospital, Beijing
Conditions	Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
Enrollment	141 participants
Start Date	2024-05-29
Primary Completion	2025-06-19 (estimated)
Study Completion	2025-07-28 (estimated)
Updated on ClinicalTrials.gov	2026-08-10