Gender
All
Age Group
1 Month and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
2. 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.
3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
4. The TBS size \< 21 cm2/3.3 in2.
5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.
Exclusion Criteria:
1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
2. Congenital or acquired disorders of coagulation.
3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
4. Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) \> 1.5.
5. Acute major bleeding during surgery.
6. Participant with TBS in an actively infected field.
7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
