Adjunctive Application of BioFoam Surgical Matrix in Liver Surgery
Condition: Intraoperative Bleeding
MeSH terms: Hemorrhage; Blood Loss, Surgical
Intervention: BioFoam Surgical Matrix; Gelfoam Plus
Intervention description: Surgical adjunct to control bleeding in open liver surgery; Surgical adjunct in control of bleeding in open liver surgery
Intervention MeSH terms: Thrombin; Gelatin Sponge, Absorbable
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemostatic agent; Liver surgery; Hemostasis

Summary:

      This is a prospective, multicenter, randomized, controlled investigation. Subjects in which
      bleeding from the exposed parenchymal surface is observed intraoperatively following the
      ligature of vessels visible with the unaided eye will be randomized to an adjunctive
      application of BioFoam or a standard topical hemostatic agent (Gelfoam with thrombin, in the
      form of Gelfoam Plus) to the entire exposed parenchymal surface. Following primary treatment
      of the exposed parenchymal surface as prescribed by the randomization scheme, treatment sites
      will be visually evaluated for the continued presence of bleeding. The overall objective of
      this investigation is to collect clinical data concerning the safety and effectiveness of
      BioFoam used as an adjunct to conservative measures of achieving hemostasis, such as manual
      pressure, cautery, and ligation, for intraoperative capillary, arteriolar, and venular
      bleeding (5 second stack of 5 gauze surface "Bleeding Score" = 1b or 2, score to be
      validated) on newly resected liver parenchyma in hemodynamically stable (American College of
      Surgeons' Advanced Trauma Life Support Class I Hemorrhage) and non-coagulopathic patients in
      the open treatment of exposed liver parenchyma versus a standard topical hemostatic agent,
      Gelfoam Plus. It is not intended for traumatic liver injury. The investigation will be
      conducted at a maximum of three investigational sites.
    

Eligibility criteria:

        Preoperative Inclusion Criteria:

          -  Subject is undergoing an elective liver resection procedure that requires treatment of
             the exposed parenchymal surface due to the intraoperative presence of blood following
             ligature of vessels visible with the unaided eye;

          -  Subject has adequate hepatic function as indicated by a Model for End-Stage Liver
             Disease (MELD) score of <10 at ≤30 days and at ≤7 days prior to surgery;

          -  Subject has adequate hemostatic function identified as an international normalized
             ratio (INR), platelet count, and activated clotting time within the central
             laboratory's normal reference range;

          -  Subject or an authorized legal representative is willing and able to give prior
             written informed consent for investigation participation; and

          -  Subject is ≥ 18 years of age.

        Preoperative Exclusion Criteria:

          -  Subject with known or suspected sensitivity to products of bovine origin

          -  Subject with known or suspected sensitivity to glutaraldehyde

          -  Subject with active infection (either systemic or in the treatment region) or hepatic
             cysts due to parasitic disease and/or abscesses due to bacterial and/or amebic
             disease;

          -  Subject with abnormal calcium metabolism identified as values for ionized calcium and
             serum calcium corrected for serum albumin that are outside of the central laboratory's
             normal reference range;

          -  Subject with abnormal renal status identified as an estimated glomerular filtration
             rate (eGFR), blood urea nitrogen (BUN), serum creatinine, sodium, chloride, potassium,
             and/or bicarbonate values that are outside of the central laboratory's normal
             reference range;

          -  Subject with hyperparathyroidism identified as an intact parathyroid hormone level >72
             pg/mL, serum calcium >10.6 mg/dL, and phosphate <2.4 mg/dL, and, for secondary or
             tertiary hyperparathyroidism only, alkaline phosphatase >147 U/L

          -  Subject with a pancreatic amylase and/or lipase value outside of the central
             laboratory's normal reference range;

          -  Subject with blunt and/or penetrating liver trauma;

          -  Subject diagnosed with any coagulation disorder;

          -  Subject whose life-expectancy is less than that required for the prescribed follow-up
             duration;

          -  Subject who has been treated with an investigational product and has not completed the
             entire follow-up period for that investigational product;

          -  Subject with any surgical implant that would interfere with necessary follow-up
             imaging;

          -  Subject who is pregnant (as confirmed by a urine pregnancy test), planning on becoming
             pregnant during the follow-up period, or actively breast-feeding;

          -  Subject who is undergoing concomitant procedures other than (1) cholecystectomy, (2)
             umbilical hernia repair, or (3) uncomplicated colon resection (i.e., no significant
             spillage);

          -  Subject who is immunocompromised;

          -  Subject with an American Society of Anesthesiologist (ASA) Score >2

          -  Subject with a MELD score of ≥10 at ≤30 days or at ≤7 days prior to surgery;

          -  Subject diagnosed with an autoimmune disease; and

          -  Subject in whom the surgeon intends to use adhesion prevention products.

          -  Subject who is returning to the operating room (OR) to address a complication
             associated with a liver resection, including but not limited to hematoma evacuation
             and biliary leak.

        Intraoperative Inclusion Criterion:

        - Subject in whom bleeding (assignment of a "Bleeding Score" of 1 or 2) from the exposed
        parenchymal surface after ligature of vessels visible with the unaided eye and removal of
        any clamps used for hemostasis is observed

        Intraoperative Exclusion Criterion:

        - Subject in whom any major intraoperative bleeding incidences during the resection
        procedure occurred (i.e., subject with assignment of an American College of Surgeons
        Advanced Trauma Life Support Hemorrhage Class of II, III, or IV Hemorrhage)