Conditions: Bleeding (Oozing) in Hepatic Resection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

Brief summary:
The purpose of the study is to compare safety and efficacy of Fibrin Sealant (FS) Vapor Heated (VH) S/D 500 s-apr with manual compression as a supportive treatment of local bleeding (i.e. oozing) in hepatic resection surgery when standard surgical techniques are insufficient.

Detailed description:

Arms:
arm 1: Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment. arm 2: A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.

Interventions: intervention 1: Fibrin Sealant (FS) VH S/D 500 s-apr intervention 2: Manual compression
Intervention descriptions: intervention 1: Dosage form: spray application; dosage frequency: single application intervention 2: Dosage form: surgical gauze swab; dosage frequency: single application

Protocol document: