Dural Medical Adhesive for Watertight Sealing in Dural Repair

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.

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.