The Efficacy and Safety of a Latest Dural Substitute

Study Overview
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Brief Summary
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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 .

Official Title
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A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Lyoplant Onlay in Repairing Cerebral Dura Mater

Conditions
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Cerebrospinal Fluid Leak

Intervention / Treatment
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* Device: Lyoplant Onlay
* Device: DURAFORM


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DURAFORM<br>DURAFORM was used in repairing cerebral dura mater. | Device: DURAFORM<br>* DURAFORM is a kind of conventional artificial Dura Mater<br>|
| Experimental: Lyoplant Onlay<br>Lyoplant Onlay was used in repairing cerebral dura mater. | Device: Lyoplant Onlay<br>* Lyoplant Onlay is a kind of latest artificial Dura Mater<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dura Mater, Cerebrospinal Fluid Leak