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| Name | Class |
|---|---|
| OMRIX Biopharmaceuticals | INDUSTRY |
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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.
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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fibrin Sealant 2 (FS2) |
|
| 2 | Active Comparator | Oxidized Regenerated Cellulose (Surgicel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant 2 (FS2) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic success within 10 minutes. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of bleeding at pre-defined time points within 10 minutes | Intraoperative | |
| Incidence of treatment failures | Intraoperative | |
| Incidence of potential bleeding-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Hart, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | United States | ||
| Jacksonville Center for Clinical Research |
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|
| Oxidized Regenerated Cellulose (Surgicel) | Device | Commercially available Surgicel used within label. |
|
|
| 24 hr prior to discharge, Day 7-14 |
| Adverse events | Intraoperative, 24 hr prior to discharge, Day 7-14 |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| Miami Research Associates | Miami | Florida | 33173 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| The Iowa Clinic | Des Moines | Iowa | 50309 | United States |
| St. Agnes Healthcare, Inc. | Baltimore | Maryland | 21229 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| Mt. Sinai Hospital | New York | New York | 10029 | United States |
| GYN Oncology Associates | Syracuse | New York | 13202 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15206 | United States |
| Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D014014 | Tissue Adhesives |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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