Dural Medical Adhesive for Watertight Sealing in Dural Repair

August 4, 2026 updated by: Medprin Regenerative Medical Technologies Co., Ltd.

A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University
      • Guangzhou, China
        • Nanfang Hospital, Southern Medical University
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
      • Shenzhen, China
        • Shenzhen Second People's Hospital
      • Xi'an, China
        • Xi'an Honghui Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intraoperative Watertight Sealing Success Rate
Time Frame: Intraoperatively (Visit 0)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative CSF Leakage Rate at Day 10±5
Time Frame: Postoperative day 10±5 (Visit 1)
Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
Postoperative day 10±5 (Visit 1)
Postoperative CSF Leakage Rate at Day 90±7
Time Frame: Postoperative day 90±7 (Visit 2)
Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
Postoperative day 90±7 (Visit 2)
Postoperative Drainage Volume and Drain Indwelling Duration
Time Frame: Postoperative day 10±5 (Visit 1)
Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
Postoperative day 10±5 (Visit 1)
Incidence of All Adverse Events and Serious Adverse Events
Time Frame: From surgery to postoperative day 90±7
Overall occurrence rate of treatment-emergent adverse events and serious adverse events related or unrelated to the dural medical adhesive throughout the 90-day follow-up period.
From surgery to postoperative day 90±7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medprin Regenerative Medical Technologies Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-CTP-YYJ2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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