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.
Study Type
OBSERVATIONAL
Enrollment
50
replacement and extension of connective tissue structures in neurosurgery
Universitätsklinikum Augsburg AöR
Augsburg, Bavaria, Germany
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).
Time frame: at one follow-up ≥ 3 months after surgery
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
Time frame: at one follow-up ≥ 3 months after surgery
Incidence of further (serious) adverse events in chronologic sequence
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.
Time frame: intra- and postoperative, until follow-up ≥ 3 months after surgery
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