The Fibrin Patch Soft Tissue Study
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|ClinicalTrials.gov Identifier: NCT00658723|
Recruitment Status : Completed
First Posted : April 15, 2008
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hemostasis||Drug: Fibrin Pad Device: SURGICEL™||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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).
Active Comparator: 2
SURGICEL™ Absorbable Hemostat
- Proportion of Subjects Achieving Hemostatic Success [ Time Frame: Intra-operative ]Proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period.
- Proportion of Subjects Achieving Hemostatic Success [ Time Frame: 10 minutes ]The proportion of subjects achieving hemostatic success at 10 minutes following randomization
- Incidence of Treatment Failures [ Time Frame: Intra-operative ]If hemostasis was not achieved within 4 minutes or if bleeding required additional intervention during the 6 minute observation period, the treatment was considered to be a failure.
- Incidence of Adverse Events That Are Potentially Related to Bleeding [ Time Frame: Intra-operative up to 1 month (+14 days) ]The types of events that were potentially related to bleeding included operative hemorrhage and re-bleeding of the target bleeding site (TBS).
- Incidence of Adverse Events That Are Potentially Related to Thrombotic Events [ Time Frame: Intra-operative up to 1 month (+14 days) ]The types of events that were potentially related to thrombotic events included deep vein thrombosis and pulmonary embolism
- Incidence of Adverse Events Potentially Related to Transfusion Exposure [ Time Frame: Intra-operative up to 1 month (+14 days) ]The types of events that were potentially related to transfusion exposure could have include hypocalcemia.
- Incidence of Re-treatment [ Time Frame: Intra-operative ]
The outcome measure assess if re-treatment was done after release of manual compression at 4-minutes for subjects not achieving hemostatic success or if re-treatment was done during the 6-minute observation period.
In the SURGICEL group, 18 subjects had initial hemostatic success at 4 minutes, but 2 of the 18 subjects were re-treated for re-bleeding. In the SURGICEL group, 12 subjects were not hemostatic at 4-minutes and had a re-treatment.
- Incidence of Adverse Events [ Time Frame: 30 days (+14 days) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658723
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|Jacksonville Center for Clinical Research|
|Jacksonville, Florida, United States, 32216|
|Miami, Florida, United States, 33173|
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Medical College of Georgia|
|Augusta, Georgia, United States, 30912|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|St. Agnes Healthcare, Inc.|
|Baltimore, Maryland, United States, 21229|
|United States, New York|
|Long Island Jewish Medical Center|
|NEw Hyde Park, New York, United States, 11040|
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18103|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Weill Medical Colleges of Cornell University - Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Director:||James Hart, M.D.||Ethicon, Inc.|