Trials / Completed
CompletedNCT01166243
The Fibrin Pad Liver Study
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (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 and hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fibrin Pad | Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
| PROCEDURE | Standard of Care | Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-08-01
- Completion
- 2011-10-01
- First posted
- 2010-07-21
- Last updated
- 2014-01-20
Locations
9 sites across 5 countries: Australia, Germany, Netherlands, New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT01166243. Inclusion in this directory is not an endorsement.