A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

Inclusion criteria

• Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
• The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
• Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
• The TBS size < 21 cm2/3.3 in2.
• Ability to firmly press study intervention at TBS until 3 minutes after randomization.

Exclusion criteria

• Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
• Congenital or acquired disorders of coagulation.
• Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
• Screening Hemoglobin < 9 mg/dL, platelets < 75 × 103/µL, and/or international normalized ratio (INR) > 1.5.
• Acute major bleeding during surgery.
• Participant with TBS in an actively infected field.
• Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
• Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
• Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.