Study Comparing Safety and Effectiveness of CraniSeal and DuraSeal Dural Sealants Used in Elective Brain Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two dural sealant devices, CraniSeal and DuraSeal, used during elective cranial surgeries. This post-approval study aims to determine whether CraniSeal is no worse than DuraSeal in preventing cerebrospinal fluid CSF leaks after surgery. The study also collects data on safety outcomes such as surgical site infections and adverse events related to the devices. Participants will be randomly assigned to receive either the CraniSeal or DuraSeal dural sealant as an addition to traditional sutured dural closure during their cranial surgery. Both devices are PEG-based dural sealants. The study is single-blinded and focuses on procedures involving either infratentorial or supratentorial cranial surgery with a clean surgical wound classification. During the study, participants will be monitored for 90 days after surgery to assess the absence of CSF leaks, the primary outcome measure. Researchers will also track additional safety outcomes and adverse events. Participants must comply with follow-up visits and evaluations as part of the study process. The total duration includes the postoperative period up to 90 days for safety and effectiveness assessments.

CraniSeal Post Approval Study