To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
224
Keck Medical Center at USC
Los Angeles, California, United States
COMPLETEDMayo Clinic
Jacksonville, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
Absence of CSF Leaks
absence of CSF leaks on study
Time frame: 90 days
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Augusta University
Augusta, Georgia, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGJacobs Institute
Buffalo, New York, United States
RECRUITINGPrisma Health
Greenville, South Carolina, United States
RECRUITING