SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects

This is an interventional treatment trial for Hemorrhage focused on measuring bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats Read More

Inclusion Criteria:

Pre-operative:

1. Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures;
2. Subject or authorised representative has signed the approved Informed Consent;

3. Subject(s) whose International Normalised Ratio is <1.5 within 24 hours of surgery.

   Intra-operative:

4. Presence of an appropriate TBS identified intra-operatively by the surgeon;
5. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.

Exclusion Criteria:

Pre-operative:

1. Female subjects who are pregnant or nursing;

2. Subject on anticoagulation medication (with exception of aspirin) prior to surgery. Washout periods for respective medications must be observed.

   If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication;

3. Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery.
4. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor;
5. Subjects who are known, current alcohol and/or drug abusers;

6. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure.

   Intra-operative:

7. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product;
8. Subject with TBS in an actively infected field [Class III Contaminated or Class IV Dirty or Infected (see Appendix 2 in in Section 15.2)];
9. TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel;
10. Major arterial or venous bleeding or major defects in arteries and veins;
11. TBS where silver nitrate or any other escharotic chemicals have been applied;
12. TBS is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm;
13. TBS in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study product.