Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) During Soft Tissue Open Surgeries
Condition: Soft Tissue Surgical Bleeding
Intervention: Fibrin Sealant (FS) Grifols; Surgicel®
Intervention description: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).; Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 327.0
Sex: All
Healthy volunteers: No
Keywords: Fibrin Sealant; Soft tissue open surgery; Oxidized cellulose pads

Summary:

      This study is designed to assess the safety and efficacy of fibrin sealant (FS) Grifols in
      patients undergoing elective (non-emergency) soft tissue open surgery where bleeding may be
      present. The purpose of this study is to demonstrate that FS Grifols is not inferior to
      commercially-available oxidized cellulose pads (Surgicel®) in providing benefit in the time
      to hemostasis (i.e, the stoppage of bleeding). This study has a Preliminary Part (I) for
      study teams to become familiar with the application of FS Grifols and a Primary Part (II) to
      assess the safety and efficacy of FS Grifols. In both parts of the study, patients will be
      randomized in a 1:1 ratio to either FS Grifols or Surgicel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hemoglobin (Hgb) ≥ 8.0 g/dL at Baseline (within 24 hours prior to surgical procedure).

          -  Require elective (non-emergency), open (non-laparoscopic) surgical procedure involving
             soft (non-parenchymous) tissue.

          -  Target bleeding site is identified on soft tissue during urologic, gynecologic or
             general surgery procedures: 1) Simple or radical nephrectomies, 2) Total
             adrenalectomies, 3) Radical prostatectomies, 4) Pyeloplasties, 5) Radical
             cystectomies, 6) Simple or radical hysterectomies, 7) Lymphadenectomies (in the
             retroperitoneal or pelvic region only), 8) Retroperitoneal tumor resections, 9)
             Mastopexies, and 10) Abdominoplasties.

          -  A target bleeding site can be identified.

          -  Target bleeding site has moderate bleeding according to the Investigator's judgment.

        Exclusion Criteria:

          -  Require thoracic, abdominal, retroperitoneal or pelvic surgery 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 FS 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 cut soft tissue surface
             identified as the target bleeding site prior to application of the study treatment.