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Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lyoplant® | Lyoplant® is a pure collagen implant obtained from bovine pericardium. The membrane is used for the replacement and extension of connective tissue structures in neurosurgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lyoplant® | Device | replacement and extension of connective tissue structures in neurosurgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cerebrospinal Fluid Leakage | A Cerebrospinal Fluid (CSF) leakage needs to be confirmed by radiological image evaluation (computed tomography scan, CT or magnetic resonance imaging scan, MRI). It will be documented if the CSF leak was clinically evident or not. A clinically evident CSF leak is defined as clear fluid leaking through the surgical incision or orifice (e.g., rhinorrhea or otorrhea) or as subcutaneous visible and / or palpable fluid accumulation next to or at the site of surgical incision suspected to be CSF. A non-clinically evident CSF leak is defined as CSF accumulation which could be detected only by radiological image evaluation (CT / MRI). | at one follow-up ≥ 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of re-operations with product relationship | e.g. caused by infection, foreign-body-reaction/ hypersensitivity against proteins of bovine origin/ allergic reactions to proteins of bovine origin | at one follow-up ≥ 3 months after surgery |
| Incidence of further (serious) adverse events in chronologic sequence |
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Inclusion Criteria:
Exclusion Criteria:
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Patient files from adult patients with indication of surgical diagnosis (e.g. decompressive craniectomy, tumor, aneurysm, trauma etc.) in a single center are revisited and analysed for primary and secondary variables
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| Name | Affiliation | Role |
|---|---|---|
| Philipp E Krauss, Dr. | Universitätsklinikum Augsburg AöR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Augsburg AöR | Augsburg | Bavaria | 86156 | Germany |
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| ID | Term |
|---|---|
| D002551 | Cerebral Ventricle Neoplasms |
| D002528 | Cerebellar Neoplasms |
| D002532 | Intracranial Aneurysm |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
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Number of further serious adverse events e.g. meningitis, surgical site infection, inflammation rate, hematoma - with focus on events with (possible) relation to the investigational product. |
| intra- and postoperative, until follow-up ≥ 3 months after surgery |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D015192 | Infratentorial Neoplasms |
| D002526 | Cerebellar Diseases |
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |