Trials / Completed
CompletedNCT00658723
The Fibrin Patch Soft Tissue Study
A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 141 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fibrin Pad | Fibrin Patch 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). |
| DEVICE | SURGICEL™ | Absorbable hemostat |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-04-01
- Completion
- 2009-05-01
- First posted
- 2008-04-15
- Last updated
- 2014-09-11
- Results posted
- 2014-09-11
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00658723. Inclusion in this directory is not an endorsement.