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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DURAFORM | Other | DURAFORM was used in repairing cerebral dura mater. |
|
| Lyoplant Onlay | Experimental | Lyoplant Onlay was used in repairing cerebral dura mater. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyoplant Onlay | Device | Lyoplant Onlay is a kind of latest artificial Dura Mater |
| |
| Measure | Description | Time Frame |
|---|---|---|
| surgical 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. | at 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| neurosurgical complication | Incidence of intracranial infection at 2 days after operation,at discharge,and at 30 days after operation | 2 days post surgery/10 days post surgery/at 30 days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Zhang, M.D. | Contact | +86 0571 87784755 | zjm135@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| jianmin zhang, M.D. | Department of neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianmin Zhang | Recruiting | Hangzhou | Zhejiang | 310000 | China |
The committee will debate whether to share IPD depending on the circumstances. Because some patients are unwilling to make their condition known.
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| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| DURAFORM |
| Device |
DURAFORM is a kind of conventional artificial Dura Mater |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |