NCT06664788NARecruiting
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Ethicon, Inc.
Start Date
4/16/2025
Completion Date
9/28/2026
Summary
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
Eligibility Criteria
Age Range: 22 years to No maximum
Inclusion Criteria:
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)
Exclusion Criteria:
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
Interventions
DEVICE
ETHIZIA
DEVICE
SURGICEL Original
Conditions
HemostasisHemostatic Techniques
Locations
Keck Hospital of USC
Los Angeles, California 90033
United States
Washington University Barnes Jewish Hospital
St Louis, Missouri 63110
United States
Capital Health Medical Center - Hopewell
Pennington, New Jersey 08534
United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York 10065
United States
UT Health East Texas EMS Air 1
Tyler, Texas 75701
United States
Intermountain Medical Center
Murray, Utah 84107
United States
UMC Radboud
Nijmegen, 6500HB
Netherlands