Clinical Trial: A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair

Brief Summary: The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

Detailed Summary: This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.
Sponsor: Ethicon, Inc.

Current Primary Outcome: Proportion of success [ Time Frame: Day 1 (intraoperative) ]

Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of CSF leakage [ Time Frame: Day 5 post-op ]
  • Incidence of CSF leakage [ Time Frame: Day 30 post-op ]
  • Incidence of adverse events [ Time Frame: up to 30 days post-op ]
  • Incidence of surgical site infections [ Time Frame: Day 5 and 30 post-op ]


Original Secondary Outcome: Same as current

Information By: Ethicon, Inc.

Dates:
Date Received: August 3, 2010
Date Started: July 2010
Date Completion:
Last Updated: June 19, 2012
Last Verified: June 2012