Cerebrospinal Fluid Leakage, Spinal Dural Defect, Spinal Neurosurgery
Conditions
Keywords
dural repair, CSF leak, dural sealant, spinal surgery
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.
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.
Interventions
DEVICEDural 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.
PROCEDUREStandard 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.
Sponsors
Medprin Regenerative Medical Technologies Co., Ltd.
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Watertight Sealing Success Rate | Intraoperatively (Visit 0) | Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative CSF Leakage Rate at Day 10±5 | 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 CSF Leakage Rate at Day 90±7 | 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 Drainage Volume and Drain Indwelling Duration | 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. |
| Incidence of All Adverse Events and Serious Adverse Events | 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. |
Countries
China
Outcome results
None listed