Dural Medical Adhesive for Watertight Sealing in Dural Repair

Completed · Phase 3

Conditions studied: Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery

In brief

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.

Key facts

Study ID

NCT07754344

Run by

Medprin Regenerative Medical Technologies Co., Ltd.

People needed

141

Starts

2024-05-29

Expected to finish

2025-07-28

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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