Monitoring the Use of Collagen Dura Membrane in the Post-market phase
A multi-center clinical series of 110 patients treated with Collagen Dura Substitute Membrane (DuraMatrix \& DuraMatrix Onlay) for a dural defect in the dura mater will be evaluated prospectively. Patients will have follow-up time points through at least 6-9 months which align with the lifetime of the device. The primary endpoint of the study will be the presence of adverse events leakage that require surgical intervention, will be evaluated at each follow-up time point. The secondary endpoint of the study will be adverse events i.e. infection, Cerebrospinal fluid leak (CSF) and Pseudomeningocele. No patient records or personal identifying information will be disclosed to Collagen Matrix.
Study Type
OBSERVATIONAL
Enrollment
110
Medical Collagen of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITINGMeasurement of the occurrence of adverse event requiring surgical intervention
Time frame: 6-9 months
Adverse events i.e., infection, CSF leak and Pseudomeningocele
Time frame: 6-9 months
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