Clinical Trial: DuraSeal Exact Spine Sealant System Post-Approval Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: DuraSeal Exact Spine Sealant System Post-Approval Study

Brief Summary: This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Detailed Summary:
Sponsor: Integra LifeSciences Corporation

Current Primary Outcome: Post-operative CSF leaks [ Time Frame: 90 days post-operative ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Post-operative surgical site infections [ Time Frame: 90 days post-operative ]
  Deep surgical site infections as defined by the Center for Disease Control criteria.
• Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ]

Original Secondary Outcome: Same as current

Information By: Integra LifeSciences Corporation

Dates:
Date Received: August 4, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017