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Sponsors and Collaborators: |
Ethicon, Inc. OMRIX Biopharmaceuticals |
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Information provided by: | Ethicon, Inc. |
ClinicalTrials.gov Identifier: | NCT00307515 |
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
Condition | Intervention | Phase |
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Blood Loss, Surgical |
Drug: Fibrin Sealant 2 (FS2) Device: Oxidized Regenerated Cellulose (Surgicel) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Enrollment: | 135 |
Study Start Date: | February 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Fibrin Sealant 2 (FS2)
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Drug: Fibrin Sealant 2 (FS2)
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
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2: Active Comparator
Oxidized Regenerated Cellulose (Surgicel)
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Device: Oxidized Regenerated Cellulose (Surgicel)
Commercially available Surgicel used within label.
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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®.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Children's Hospital of Los Angeles | |
Los Angeles, California, United States, 90027 | |
United States, Florida | |
Miami Research Associates | |
Miami, Florida, United States, 33173 | |
Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
United States, Iowa | |
The Iowa Clinic | |
Des Moines, Iowa, United States, 50309 | |
United States, Maryland | |
St. Agnes Healthcare, Inc. | |
Baltimore, Maryland, United States, 21229 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 | |
United States, New York | |
GYN Oncology Associates | |
Syracuse, New York, United States, 13202 | |
Mt. Sinai Hospital | |
New York, New York, United States, 10029 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Lehigh Valley Hospital | |
Allentown, Pennsylvania, United States, 18103 | |
Lankenau Hospital | |
Wynnewood, Pennsylvania, United States, 19096 | |
Children's Hospital of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15206 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
The Methodist Hospital | |
Houston, Texas, United States, 77030 |
Study Director: | James Hart, MD | Ethicon, Inc. |
Responsible Party: | Ethicon ( Jonathan Batiller, MBA ) |
Study ID Numbers: | 400-05-006 |
Study First Received: | March 23, 2006 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00307515 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Thrombin Calcium, Dietary Fibrin Tissue Adhesive Blood Loss, Surgical |
Intraoperative Complications Hemorrhage Hemostatics |
Pathologic Processes Coagulants Fibrin Tissue Adhesive Therapeutic Uses Hematologic Agents |
Blood Loss, Surgical Intraoperative Complications Hemorrhage Pharmacologic Actions Hemostatics |