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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Adjunct to hemostasis
Adjunct to hemostasis
Torrance Memorial
Torrance, California, United States
RECRUITINGSt. Anthony Hospital
Lakewood, Colorado, United States
RECRUITINGGeorgetown University
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
Time frame: within 3 minutes of study intervention
Hemostatic success within 6 minutes
Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention
Time frame: within 6 minutes of study intervention
Study intervention failures
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
Time frame: 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
Time frame: within 3 minutes of study intervention
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Washington D.C., District of Columbia, United States
University Of Chicago
Chicago, Illinois, United States
RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGAtrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
RECRUITINGThe Ohio State University Medical Center
Columbus, Ohio, United States
RECRUITING