An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.
Corza Medical GmbH
Summary
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.
Eligibility
- Age range
- 0+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included. 2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale. 3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon. 4. The TBS size \< 21 cm2/3.3 in2. 5. Ability to firmly press study intervention at TBS until 3 minutes after randomization. Exclusion Criteria…
Interventions
- BiologicalTachoSil
Adjunct to hemostasis
- BiologicalSurgicel Original
Adjunct to hemostasis
Locations (9)
- Torrance MemorialTorrance, California
- St. Anthony HospitalLakewood, Colorado
- Georgetown UniversityWashington D.C., District of Columbia
- University Of ChicagoChicago, Illinois
- Indiana UniversityIndianapolis, Indiana
- University of LouisvilleLouisville, Kentucky