Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Parenchymous Tissue Open Surgeries

Exclusion Criteria

• •Require hepatic resection due to trauma.
• •Infection in the anatomic surgical area.
• •History of severe (e.g. anaphylactic) reactions to blood or to any blood-derived product.
• •Previous known sensitivity to any Fibrin Sealant Grifols component or any Surgicel® component.
• •Females who are pregnant or nursing a child at Baseline (within 24 hours prior to surgical procedure).
• •Receiving an organ transplant during the same surgical procedure.
• •Undergone a therapeutic surgical procedure within 30 days from the screening visit.
• •A target bleeding site cannot be identified.
• •The target bleeding site has a mild or severe bleeding.
• •Occurrence of major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
• •Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.