A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery
The time it will take to stop bleeding will be measured and compared between patients who
are treated with fibrin sealant 2 to those who are treated with Surgicel®.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Hemostatic success within 10 minutes.
Intraoperative
Yes
James Hart, MD
Study Director
Ethicon, Inc.
United States: Food and Drug Administration
400-05-006
NCT00307515
February 2006
December 2006
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Cooper University Hospital | Camden, New Jersey 08103 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Medical College of Georgia | Augusta, Georgia 30912 |
The Methodist Hospital | Houston, Texas 77030 |
Oregon Health and Science University | Portland, Oregon 97201 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
St. Agnes Healthcare, Inc. | Baltimore, Maryland 21229-5299 |
Jacksonville Center for Clinical Research | Jacksonville, Florida 32216 |
Mt. Sinai Hospital | New York, New York 10029 |
Children's Hospital of Los Angeles | Los Angeles, California 90027 |
Miami Research Associates | Miami, Florida 33173 |
The Iowa Clinic | Des Moines, Iowa 50309 |
GYN Oncology Associates | Syracuse, New York 13202 |