Trials / Completed
CompletedNCT01174992
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 139 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evicel | EVICEL is a human plasma derived fibrin sealant |
| OTHER | Sutures only | Standard of care |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-09-01
- Completion
- 2011-10-01
- First posted
- 2010-08-04
- Last updated
- 2012-06-20
Locations
12 sites across 6 countries: Belgium, Finland, France, Germany, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT01174992. Inclusion in this directory is not an endorsement.