Cerebrospinal Fluid Leak
Conditions
Keywords
Dura Mater, Cerebrospinal Fluid Leak
Brief summary
This prospective, multi-center, randomized, parallel-controlled clinical trial was designed to evaluate the efficacy and safety of Lyoplant Onlay in repairing cerebral dura mater. DURAFORM was regarded as the control group. a total of 80 patients were randomized into experimental and control group (1:1).Data were collected on complications resulting in CSF leaks, surgical site infections, instrument performance parameterized other neurological complications within 30 days. Surgeons also provided data on the ease of use of the dural sealing techniques, as well as preparation and application times. The above-mentioned date were used to evaluate the efficacy and safety of Lyoplant Onlay .
Interventions
DEVICELyoplant Onlay
Lyoplant Onlay is a kind of latest artificial Dura Mater
DEVICEDURAFORM
DURAFORM is a kind of conventional artificial Dura Mater
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang 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
* Any patient between the ages of 18 and 75 years scheduled for elective cranial surgery involving a dural incision. * Dural defects and surgical incision was classifed as level 1
Exclusion criteria
* local or systemic infection. * patients with known allergy to Equipment components * a history of traumatic head injury * a compromised immune system or autoimmune disease * patients who should not participate based on the surgeon's opinion * patients participating in any other drug or device trial. * expected survival time \<12 months * underwent chemoradiotherapy 3 months before randomization * uncontrolled diabetes and malignant tumor * women who were pregnant, lactating, or wished to become pregnant during the study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgical successful rate | at 30 days post surgery | proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| neurosurgical complication | 2 days post surgery/10 days post surgery/at 30 days post surgery | Incidence of intracranial infection at 2 days after operation，at discharge，and at 30 days after operation |
Countries
China
Contacts
Primary ContactJianmin Zhang, M.D.
Outcome results
None listed