Fibrin Sealant VH S/D 500 S-apr in Hepatic Resection
Condition: Bleeding (Oozing) in Hepatic Resection
Intervention: Fibrin Sealant (FS) VH S/D 500 s-apr; Manual compression
Intervention description: Dosage form: spray application; dosage frequency: single application; Dosage form: surgical gauze swab; dosage frequency: single application
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Pre-Operative Inclusion Criteria:

          -  Signed informed consent obtained from the subject before any study-related activities

          -  Subject's age is 18 years or above

          -  Subject will undergo planned, elective resection of at least 1 anatomical segment of
             the liver for any reason by laparotomy

          -  Subject is willing and able to comply with the requirements of the protocol

          -  Female subjects of childbearing potential must present with a negative serum or urine
             pregnancy test within 72 hours before the elective liver resection

          -  Female subjects of childbearing potential must agree to employ adequate birth control
             measures for the time of their participation in the study

        Intra-Operative Inclusion Criteria (before randomization):

          -  Resection of at least 1 anatomical segment of the liver has been performed

          -  Oozing from the cut surface of the liver persists after conventional resection
             procedure and primary control of arterial and venous bleeding by sutures, ligations,
             clips, vascular stapler, point electrocautery or focal radiofrequency ablation

          -  Need for additional supportive hemostatic treatment to stop bleeding (i.e. diffuse
             oozing) of the liver resection area

        Pre-Operative Exclusion Criteria:

          -  Subject needs emergency liver surgery

          -  Subject will undergo liver resection via laparoscopic procedure

          -  Subject has known congenital coagulation disorder (e.g. hemophilia)

          -  Subject has known hypersensitivity to any ingredient of the investigational medicinal
             product

          -  Suspected inability or unwillingness of the subject to comply with trial procedures

          -  If female, subject is pregnant or lactating at the time of study enrollment

          -  Subject has already participated in this study (each subject can only be enrolled
             once)

          -  Subject has participated in another clinical study involving an investigational
             product or investigational device within 30 days prior to study enrollment or is
             scheduled to participate in another clinical study involving an investigational
             product or investigational device during the course of this study

        Intra-operative Exclusion Criteria (before randomization):

          -  Occurrence of any severe surgical complication that require resuscitation or deviation
             from the planned surgical procedure

          -  Disseminated intravascular coagulopathy (DIC)

          -  Application of any topical hemostatic material on the resection surface of the liver
             prior to application of the study treatment

          -  Radiofrequency precoagulation of the liver resection surface, except focal use of
             radiofrequency as primary hemostatic treatment