A Phase 3 interventional study of Dural medical adhesive and Standard dural reinforcement surgery in Spinal Dural Defect, Cerebrospinal Fluid Leakage and Spinal Neurosurgery, sponsored by Medprin Regenerative Medical Technologies Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Medprin Regenerative Medical Technologies Co., Ltd. · Phase 3, Interventional, and Prevention
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.
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.
41 studies on the registry are indexed under Cerebrospinal Fluid Leak; 9 are open to participants now.
This study's enrollment of 141 is above the median of 74 across 24 interventional studies indexed under Cerebrospinal Fluid Leak.
Browse Cerebrospinal Fluid Leak studies →Medprin Regenerative Medical Technologies Co., Ltd. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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, 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.
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.
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.
Time frame: Intraoperatively (Visit 0)
Postoperative CSF Leakage Rate at Day 10±5
Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
Time frame: Postoperative day 10±5 (Visit 1)
Postoperative CSF Leakage Rate at Day 90±7
Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
Time frame: Postoperative day 90±7 (Visit 2)
Postoperative Drainage Volume and Drain Indwelling Duration
Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
Time frame: Postoperative day 10±5 (Visit 1)
Incidence of All Adverse Events and Serious Adverse Events
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.
Time frame: From surgery to postoperative day 90±7
Plan to share: No
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Ran from May 2024 to primary completion in Jun 2025, 12 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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