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The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for > 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TachoSil | Experimental |
| |
| Surgicel Original | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TachoSil | Biological | Adjunct to hemostasis |
| |
| Surgicel Original |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic success within 3 minutes | Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention | within 3 minutes of study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic success within 6 minutes | Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention | within 6 minutes of study intervention |
| Study intervention failures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff Wilson | Contact | 1 416-578-9058 | Jeff.wilson@corza.com | |
| Michele Young | Contact | 1 689-316-8809 | Michele.young@corza.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Torrance Memorial | Recruiting | Torrance | California | 90505 | United States | |
| St. Anthony Hospital |
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| Biological |
Adjunct to hemostasis |
|
Proportion of study intervention failures, defined as failure to achieve hemostatic success within 6 minutes after application of study intervention or bleeding requiring additional intervention during the 6 minutes after application of study intervention
| within 6 minutes of study intervention |
| hemostatic success from moderate bleeding within 3 minutes | Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention | within 3 minutes of study intervention |
| Recruiting |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Georgetown University | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| University Of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Recruiting | Louisville | Kentucky | 40202 | United States |
| Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
| Atrium Health Carolinas Medical Center | Recruiting | Charlotte | North Carolina | 28203 | United States |
| The Ohio State University Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C518955 | TachoSil |
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