A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery
Part of paid clinical trials in Torrance, California.
- Sponsor
- Corza Medical GmbH
- Study ID
- NCT06664775
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Hemorrhage
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Month - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TachoSil — BIOLOGICALAdjunct to hemostasis
- Surgicel Original — BIOLOGICALAdjunct to hemostasis
Study Details
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.
Key Dates
- First listed
- Oct 30, 2024
- Start date
- Apr 2, 2025
- Status verified
- Jun 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 116 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TachoSil
- Active Comparator: Surgicel Original
Primary Outcome Measure
Hemostatic success within 3 minutes [ Time Frame: within 3 minutes of study intervention ]
Central Contacts
- Jeff Wilson1 416-578-9058
- Michele Young1 689-316-8809
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Torrance Memorial | Torrance | California | 90505 | - |
| St. Anthony Hospital | Lakewood | Colorado | 80228 | - |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | - |
| University Of Chicago | Chicago | Illinois | 60637 | - |
| Indiana University | Indianapolis | Indiana | 46202 | - |
| University of Louisville | Louisville | Kentucky | 40202 | - |
| Washington University | St Louis | Missouri | 63110 | - |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28203 | - |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | - |
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