The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
253
Intraoperative application as secondary hemostatic treatment
Intraoperative application as secondary hemostatic treatment
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Chicago, Illinois, United States
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes
3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Time frame: within 3 minutes
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes
3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.
Time frame: within 5 minutes
Time to Intraoperative Hemostasis at Target Bleeding Site
The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.
Time frame: 10 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Burlington, Massachusetts, United States
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St Louis, Missouri, United States
Unnamed facility
Newark, New Jersey, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Charlotte, North Carolina, United States
...and 7 more locations