A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery

Inclusion Criteria

• Patients (males or females) aged ≥ 18 years old.
• Patients requiring elective open hepatic surgery.
• Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
• Patients understanding the nature of the study and providing their informed consent prior to participation.
• Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.

Intra-operative inclusion criteria:

• Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).

Exclusion Criteria

• Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
• Patients with a severe coagulopathy defined as INR > 2.0.
• Patients with platelet count <50, 000 x109 PLT/L at the screening.
• Patients admitted to trauma surgery.
• Transplant patients due to fulminant hepatic failure.
• Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
• Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
• Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers.
• Patients suffering from claustrophobia.
• Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
• Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
• Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
• Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
• Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.

Intra-operative exclusion criteria:

• Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
• Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
• Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
• Patients having an active local infection in the anatomic surgical area.
• Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
• Patients with bleeding site in or near to foramina in bone.