A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery
A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery
The main goal of this study is to look at the effectiveness and safety of an experimental device called ?CraniSeal Dural Sealant? in people who are undergoing cranial surgery.
Inclusion Criteria:
You are scheduled for an elective neurosurgical procedure that involves opening the skull to access the brain.
Exclusion Criteria:
You had a prior neurosurgical procedure in the same anatomical location.
You are scheduled for a surgery that enters through the ear, nose, or mouth.
You have an allergy to FD&C Blue #1 dye.