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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
A synthetic absorbable medical adhesive composed of polyethylene glycol (PEG) derivatives (electrophilic and nucleophilic components) that crosslink to form a hydrogel upon mixing. It provides a watertight seal and enhances tissue adhesion through ionic interactions between cationic groups on the nucleophilic component and anions in tissue matrices. The product is biodegradable and has low swelling ratio.Guangzhou Maipu Regenerative Medical Technology Co., Ltd.
A synthetic absorbable polymeric tissue sealing film indicated as an adjunctive sealant for dural repair in neurosurgery. The product is applied directly to the dural repair site to provide a watertight seal. TissueMed Ltd. (UK) .NMPA Registration No.: 国械注进20163641547
The Second Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)
Shenzhen, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Success Rate of Postoperative Prevention of CSF Leakage
Success is defined as the absence of cerebrospinal fluid (CSF) leakage at the dural repair site, assessed by imaging (CT/MRI), laboratory tests, and clinical symptoms at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
Intraoperative CSF Leak Prevention Success Rate
Success is defined as absence of CSF leakage at the repair site after application of the test/control device, assessed by Valsalva maneuver or other effective methods.
Time frame: Intraoperative (Day of surgery)
Postoperative Subcutaneous Fluid Accumulation Rate
Presence of subcutaneous fluid accumulation assessed by imaging (CT/MRI), laboratory tests, or clinical examination (e.g., aspiration) at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
Scalp Incision Healing
Assessment of surgical wound healing based on clinical examination at Day 7 ± 3 days post-surgery.
Time frame: Day 7 ± 3 days post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.