A Trial of Absorbable Medical Adhesive for Prevention of CSF Leak

A Multicenter, Randomized, Single-Blind, Positive-Controlled, Non-Inferiority Clinical Trial of Absorbable Medical Adhesive as an Adjunctive Method for Dural Repair in Neurosurgery to Prevent Cerebrospinal Fluid Leak

This is a multicenter, randomized, single-blind, positive-controlled, non-inferiority clinical trial designed to evaluate the safety and effectiveness of an absorbable medical adhesive (developed by Guangzhou Maipu Regenerative Medical Technology Co., Ltd.) as an adjunctive 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 the control group) were enrolled across 9 centers in China. The test device is an absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives. The control device is the commercially available absorbable polymeric tissue sealing film (TissuePatchSF, TissueMed Ltd., UK NMPA Registration No. 20163641547). The primary efficacy endpoint is the success rate of postoperative prevention of CSF leakage (assessed at Day 7 ± 3 days post-surgery). Secondary efficacy endpoints include intraoperative CSF leak prevention success rate, postoperative subcutaneous fluid accumulation rate, and scalp incision healing. Safety endpoints include adverse events, serious adverse events, central nervous system infection, and pseudomeningocele. Subjects were followed for 3 months post-surgery. The study was completed in April 2021.

Inclusion Criteria:

• Age ≥ 18 years and ≤ 75 years, any gender.
• Patients undergoing neurosurgical dural (or spinal dural) repair who are at risk of CSF leakage or who have already developed CSF leakage and require adjunctive repair.
• Patient and/or legal guardian has provided written informed consent.

Exclusion Criteria:

• Participated in another clinical trial within 1 month prior to screening.
• Body temperature ≥ 37.3°C within 3 days prior to screening.
• Severe diseases of vital organs (heart, liver, kidney) or hematological diseases that would make the patient intolerant to surgery.
• History of severe allergies or severe immunodeficiency.
• Life expectancy < 3 months.
• Pregnant or breastfeeding women, or women of childbearing age with positive pregnancy test; male or female subjects not using effective contraception or planning to conceive within 3 months after study initiation.
• Poor compliance as judged by the investigator.
• Unable to understand the study description.
• Any other condition deemed unsuitable for participation as judged by the investigator.