DuraSeal Exact Spine Sealant System Post-Approval Study

This multi-center, non-randomized, two-arm, Post Approval Study will further evaluate the rate of postoperative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant for treatment of either an intentional or incidental opening of the dura compared to Control patients who receive other products and/or treatments to close the dura. Subjects must be 18 years of age or older and have had a spinal procedure where a dural opening (whether intentional or incidental) occured and was treated with either: -DuraSeal Exact Spine Sealant System (DuraSeal Sealant arm ONLY) or - Any other method of sealing the dura with the exception of DuraSeal Sealant- either spinal or cranial (Control arm ONLY)

Primary Sponsor:
Integra LifeSciences Corp.

Prinicipal Investigator:
Jonathan Sherman

Contact Phone:
202-741-2701

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