This study looks at how safe and effective a special medical device called the Collagen Dural Regeneration Matrix, or DuraMatrix-Onlay Plus, is after it's been approved for use in surgery. The device helps repair the dura mater, a protective layer around the brain and spinal cord.
The study will take place in up to 8 different locations and includes 118 people. The main goal is to see how often a second surgery is needed. Doctors will also check for problems like leaking of cerebrospinal fluid (CSF), which is the fluid around the brain and spinal cord, infections, and a condition called pseudomeningocele, where fluid gathers under the skin.
Participants will have a check-up at least 8 weeks after their surgery, which is about how long the device takes to dissolve. No personal information will be shared with the Collagen Matrix company.
- Study involves follow-up visit at least 8 weeks after surgery.
- Up to 118 people will be part of the study, and no personal data will be shared.
- Only patients needing dura repair and without certain health conditions can join.