Dural Medical Adhesive for Watertight Sealing in Dural Repair

NCT07754344 | Completed Phase 3

• 1 other identifier: MP-CTP-YYJ2024
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 6

Brief 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; Spinal Neurosurgery; Cerebrospinal Fluid Leakage

Keywords

dural repair; CSF leak; dural sealant; spinal surgery

Outcome Measures

Primary Outcomes (1)

• Intraoperative Watertight Sealing Success Rate

  Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.

  Intraoperatively (Visit 0)

Secondary Outcomes (4)

• 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

Study Arms (2)

Dural Medical Adhesive Treatment Group

EXPERIMENTAL

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.

Device: Dural medical adhesive

Standard Conventional Treatment Control Group

ACTIVE COMPARATOR

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.

Procedure: Standard dural reinforcement surgery

Interventions

Dural medical adhesive DEVICE

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.

Dural Medical Adhesive Treatment Group

Standard dural reinforcement surgery PROCEDURE

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.

Standard Conventional Treatment Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medprin Regenerative Medical Technologies Co., Ltd.: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (6)

Peking University Third Hospital

Beijing, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Shenzhen Second People's Hospital

Shenzhen, China

Location

Xi'an Honghui Hospital

Xi'an, China

Location

MeSH Terms

Conditions

Cerebrospinal Fluid Leak; Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: May 29, 2024
• Primary Completion: June 19, 2025
• Study Completion: July 28, 2025
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)