Cerebrospinal Fluid Leak
Conditions
Keywords
Cerebrospinal Fluid Leak
Brief summary
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.
Interventions
DEVICEAbsorbable Medical Adhesive
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.
DEVICETissuePatchSF (Absorbable Polymeric Tissue Sealing Film)
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
Sponsors
Medprin Regenerative Medical Technologies Co., Ltd.
The Second Affiliated Hospital of Air Force Military Medical University
Second Affiliated Hospital of Shantou University Medical College
General Hospital of Ningxia Medical University
Shenzhen Second People's Hospital
Huazhong University of Science and Technology Union Shenzhen Hospital (Shenzhen Nanshan People's Hospital)
Second Affiliated Hospital of Nanchang University
Qinghai People's Hospital
The First Affiliated Hospital of Nanchang University
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Postoperative Prevention of CSF Leakage | Day 7 ± 3 days post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative CSF Leak Prevention Success Rate | Intraoperative (Day of surgery) | 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. |
| Postoperative Subcutaneous Fluid Accumulation Rate | Day 7 ± 3 days post-surgery | 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. |
| Scalp Incision Healing | Day 7 ± 3 days post-surgery | Assessment of surgical wound healing based on clinical examination at Day 7 ± 3 days post-surgery. |
Countries
China
Outcome results
None listed