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Dural Medical Adhesive for Watertight Sealing in Dural Repair

NCT07754344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2026-08-10

No results posted yet for this study

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.

Conditions

  • Spinal Dural Defect
  • Cerebrospinal Fluid Leakage
  • Spinal Neurosurgery

Interventions

DEVICE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Medprin Regenerative Medical Technologies Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-29
Primary Completion
2025-06-19
Completion
2025-07-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07754344 on ClinicalTrials.gov