CraniSeal Post Approval Study is a research study comparing two products, CraniSeal and DuraSeal, used to prevent cerebrospinal fluid (CSF) leaks after brain surgery. In brain surgeries, the covering of the brain, called the dura, is sometimes cut, and these products help seal it. The study aims to ensure CraniSeal is just as safe and effective as DuraSeal. Researchers will also check for any infections or problems related to the surgery or the devices used.
Eligibility: You must be over 18 years old and scheduled for a specific type of brain surgery. You need to be healthy enough to participate and sign a consent form. Some conditions, like certain infections, previous brain surgeries in the same area, or having a weak immune system, might prevent you from joining.
- The study involves follow-up visits to monitor your recovery.
- Participants cannot have certain health conditions, such as severe kidney or liver problems.
- You need to commit to the study schedule and procedures.