The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Topical Hemostat
Unnamed facility
Innsbruck, Austria
Unnamed facility
Hanover, Germany
Unnamed facility
München, Germany
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
Proportion of Subjects Who Achieve Hemostasis Within 1 Minute
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
Median Time to Achieve Hemostasis
Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
Time frame: Intra-operative (Day 0)
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