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The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign Dural or Duraplasty Repair Grafts | Device | Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage | Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis). | 2 months |
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Inclusion Criteria:
1. Planned use of the Biodesign Dural or Duraplasty Graft.
Exclusion Criteria:
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Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Hospital | Birmingham | Alabama | 35294 | United States | ||
| Toronto Western Hospital |
Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| D002558 | Cerebrospinal Fluid Otorrhea |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| Toronto |
| Ontario |
| M5T 2S8 |
| Canada |
| Ospedale Bellaria-Bolonga | Bologna | 40139 | Italy |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |