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
Pramand LLC
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria: 1. Patient is ≥ 18 years of age 2. Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision 3. Patient requires a procedure involving surgical wound classification Class I/Clean 4. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures. 5. Patients who are able to comply with study requirements. General Exclusion Criteria: 1. Patient requires a procedure involving translabyrinthine, transsphenoidal, tra…
Interventions
- DeviceCraniSeal
CraniSeal is a PEG Dural Sealant
- DeviceDuraSeal
DuraSeal is a PEG Dural Sealant
Locations (8)
- Keck Medical Center at USCLos Angeles, California
- Mayo ClinicJacksonville, Florida
- Tampa General HospitalTampa, Florida
- Augusta UniversityAugusta, Georgia
- Brigham and Women's HospitalBoston, Massachusetts
- Mayo ClinicRochester, Minnesota