A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
Commercially available Surgicel used within label.
Children's Hospital of Los Angeles
Los Angeles, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Hemostatic success within 10 minutes.
Time frame: Intraoperative
Absence of bleeding at pre-defined time points within 10 minutes
Time frame: Intraoperative
Incidence of treatment failures
Time frame: Intraoperative
Incidence of potential bleeding-related complications
Time frame: 24 hr prior to discharge, Day 7-14
Adverse events
Time frame: Intraoperative, 24 hr prior to discharge, Day 7-14
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