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 .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Lyoplant Onlay is a kind of latest artificial Dura Mater
DURAFORM is a kind of conventional artificial Dura Mater
Jianmin Zhang
Hangzhou, Zhejiang, China
RECRUITINGsurgical successful rate
proportion of treated patients free of CSF leak diagnosed by physical examination, biochemical assay, or imaging study within 30 d of the surgical procedure.
Time frame: at 30 days post surgery
neurosurgical complication
Incidence of intracranial infection at 2 days after operation,at discharge,and at 30 days after operation
Time frame: 2 days post surgery/10 days post surgery/at 30 days post surgery
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