Trials / Completed
CompletedNCT00977925
The Severe Soft Tissue Bleeding Study
A Phase III Randomized, Controlled, Superiority Study Evaluating the Fibrin Pad Versus Standard of Care Treatment in Controlling Severe Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 91 (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 hemostatic effectiveness of the Fibrin Pad (FP) versus standard of care treatment (SoC) in controlling challenging severe soft tissue bleeding during abdominal, pelvic, retroperitoneal, and (non-cardiac) thoracic 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 severe bleeding. |
Timeline
- Start date
- 2009-08-01
- Primary completion
- 2011-01-01
- Completion
- 2011-03-01
- First posted
- 2009-09-16
- Last updated
- 2015-10-01
Locations
17 sites across 4 countries: Australia, Germany, New Zealand, United Kingdom
Source: ClinicalTrials.gov record NCT00977925. Inclusion in this directory is not an endorsement.