CompletedPhase 3

Dural Medical Adhesive for Watertight Sealing in Dural Repair

China141 participantsStarted 2024-05-29

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative Watertight Sealing Success Rate

Timeframe: Intraoperatively (Visit 0)

Trial details

NCT IDNCT07754344

SponsorMedprin Regenerative Medical Technologies Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-19

View on ClinicalTrials.gov More Spinal Dural Defect trials