The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Topical hemostat
Topical hemostat
Unnamed facility
Innsbruck, Austria
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Hanover, Germany
Unnamed facility
Heidelberg, Germany
Median Time to Achieve Hemostasis Following Application of Study Treatment.
Stopwatches will be provided to document time to 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 1)
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
Stopwatches will be provided to document time to 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 1)
Number of Subjects With Treatment-emergent Adverse Events
Time frame: Up to 30 days post surgery.
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Unnamed facility
München, Germany