A prospective, multi-center, randomized controlled study to compare the Spinal Sealant System as an adjunct to sutured dural repair with standard of care methods during spinal surgery

Patients who are scheduled for spinal surgery requiring an intentional dural incision may be considered for this study.  The lining that covers the brain and spinal cord is called the dura. The dura holds in a fluid called cerebrospinal fluid (CSF). CSF provides a liquid cushion for the brain and spinal cord. The purpose of the research is to study a new device, the Spinal Sealant System or “Spinal Sealant.” The study will compare use of the spinal sealant to standard methods used to seal the dura to stop CSF from leaking out.

To perform the surgery, the doctor will make an opening in the dura. At the end of the surgery, the dura must be closed to stop the CSF from leaking out of the opening. The doctor will close the opening in the dura with stitches and might also use a piece of muscle, fat or other soft tissue taken from another place on the subject's body to help close the hole and prevent a CSF leak. This research study will compare the way that the doctor normally closes the dura to a new Spinal Sealant System.

The Spinal Sealant is made of two liquids. When mixed, the liquids form a gel that is mostly made up of water. The gel looks and feels somewhat like a soft contact lens. After the doctor closes the opening in the dura with stitches, the gel is applied over the stitches. It acts as a thin, stretchy film meant to stop the CSF from leaking through the stitches, until the area heals on its own. The gel is blue so the doctor can see where it has been applied. The body naturally breaks down the gel one to two months after it is applied and it is removed through urine. The gel is currently used in brain surgery. This study will test its use in spine surgery.  

Approximately 158 U.S. subjects will take part in the study. Subjects will have about a 67 percent (or 2 out of 3) chance of being placed in the group that receives the sealant and about a 33 percent (or 1 out of 3) chance of being placed in the group that is treated using standard methods for sealing the dura.

You may be eligible to participate in this study if you:

• Are between 18 and 75 years of age
• Are scheduled for a spinal procedure that entails a dural incision
• Require a procedure involving surgical wound classification Class I/Clean (per CDC criteria)

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.