Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ethicon, Inc.
Age
22–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Pre-operative
Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
Participant is willing and able to give written informed consent for the clinical investigation participation
Intra-operative
Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical
Target Bleeding Site is identified to originate from soft tissue, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle
The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis
Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)
You may not be if
Pre-operative
Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
Participant has an active or suspected infection at the bleeding site
Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period
Intra-operative
Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine
Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency
Clareo Health | A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
