A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of subjects achieving hemostatic success
Intra-operative
No
James Hart, M.D.
Study Director
Ethicon, Inc.
United States: Food and Drug Administration
400-07-002
NCT00658723
March 2008
May 2009
Name | Location |
---|---|
University of Alabama | Birmingham, Alabama |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Medical College of Georgia | Augusta, Georgia 30912 |
St. Agnes Healthcare, Inc. | Baltimore, Maryland 21229-5299 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Emory University Hospital | Atlanta, Georgia 30322 |
Jacksonville Center for Clinical Research | Jacksonville, Florida 32216 |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Baptist Hosptial | Miami, Florida 33173 |
Weill Medical Colleges of Cornell University - Methodist Hospital | Houston, Texas 77030 |