A study to evaluate the safety and the efficacy of a sterile bio-compatible patch (sFilm-FS) in controlling bleeding during hepatic surgery.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Patients (males or females) aged = 18 years old.
2. Patients requiring elective surgery in which liver
bleeding will be encountered..
3. Hemoglobin = 8.0 g/dL within 24 hours prior to surgical procedure.
4. Patients understanding the nature of the study and providing their informed consent prior to participation.
5. Patients willing to participate in the study and able to attend the
visits and procedures foreseen by study protocol.
Intra-operative inclusion criteria:
6. Patients with a target bleeding site (TBS) identified by the
Investigator during surgery in which liver bleeding will be
encountered.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Patients having undergone a therapeutic surgical procedure within
30 days from the study enrolment.
2. Patients with a severe coagulopathy defined as INR > 2.0.
3. Patients with platelet count <50,000 x109 PLT/L at the screening.
4. Patients admitted to trauma surgery.
5. Transplant patients due to fulminant hepatic failure.
6. Patients with known or suspected allergy or hypersensitivity to
blood products or to one of the components of sFilm-FS or the
active-comparator.
7. Patients with anesthesia risk judged to be higher than ASA3 by the
Investigator.
8. 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.
9. Patients suffering from claustrophobia.
10. 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.
11. Patients being treated with at least one of the following treatments:
antibiotic therapy for active infection, fibrin sealants, systemic
steroids or immunosuppressive agents.
12. Patients who are participating or have participated in other clinical
studies within the 30 days before the study enrolment.
13. 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.
14. Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception. *
Intra-operative exclusion criteria:
15. Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
16. Patients identified by the Investigator to have intra-operative
bleeding from large defects in large arteries or veins, requiring
repair.
17. Patients identified by the Investigator to have intra-operative
findings that may preclude conduct of study procedure.
18. Patients having an active local infection in the anatomic surgical area.
19. Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical
procedure.
20. Patients with bleeding site in or near to foramina in bone.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials