A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

This is a multicenter, randomized, single‐blind, positive‐controlled, non‐inferiorityclinical trial designed to evaluate the safety and effectiveness of an absorbable medicaladhesive (developed by Guangzhou Maipu Regenerative Medical Technology Co., Ltd.) as anadjunctive method for dural repair in neurosurgery to prevent cerebrospinal fluid (CSF)leakage. A total of 132 subjects (1:1 randomization, 66 in the test group and 66 in thecontrol group) were enrolled across 9 centers in China. The test device is an absorbablemedical adhesive composed of polyethylene glycol (PEG) derivatives. The control device isthe commercially available absorbable polymeric tissue sealing film (TissuePatchSF,TissueMed Ltd., UK NMPA Registration No. 20163641547). The primary efficacy endpoint isthe success rate of postoperative prevention of CSF leakage (assessed at Day 7 ± 3 dayspost‐surgery). Secondary efficacy endpoints include intraoperative CSF leak preventionsuccess rate, postoperative subcutaneous fluid accumulation rate, and scalp incisionhealing. Safety endpoints include adverse events, serious adverse events, central nervoussystem infection, and pseudomeningocele. Subjects were followed for 3 monthspost‐surgery. The study was completed in April 2021.