A multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in subjects undergoing open liver resection surgery. The study will enroll 42 eligible subjects and be conducted at 4 sites in the Netherlands.
This will be a multi-center, prospective, randomized, single-blind, controlled, comparative efficacy and safety trial in 60 subjects undergoing hepatic resection. Subjects will be randomized in a 2:1 ratio to Fibrocaps + Gelfoam or Gelfoam on the day of surgery. The Fibrospray device will be used to apply Fibrocaps to the Target Bleeding Site. All investigators using the Fibrospray device will be trained on the correct and safe set-up and use of Fibrocaps and the Fibrospray device prior to participating in this clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
human thrombin and fibrinogen topical powder
absorbable gelatin sponge for topical use
University Medical Center Groningen
Groningen, Netherlands
Time to Hemostasis
Time from application of treatment to cessation of bleeding
Time frame: 0-10 minutes
Safety
Number of participants with Adverse events and clinically significant changes/findings on labs and physical examination as well as incidence of re-operation for bleeding at the target bleeding site (TBS)
Time frame: 28 days
Incidence of Hemostasis at 5 Minutes
Number of subjects in each group that achieved hemostasis at pre-specified times after treatment
Time frame: 5 minutes
Number of Subjects Achieving Hemostasis at 3 Minutes
Time frame: 3 minutes
Number of Patients Achieving Hemostasis at 10 Minutes
Time frame: 10 minutes
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