Actively Recruiting
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Led by Ethicon, Inc. · Updated on 2026-05-08
108
Participants Needed
7
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for elective open abdominal, retroperitoneal, pelvic, thoracic (non-cardiac), or extremity surgery
- Able and willing to provide written informed consent
- Investigator can identify a visible bleeding site during surgery where conventional bleeding control methods are ineffective or impractical
- Bleeding site originates from soft tissue such as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, or muscle
- Decision made to use a hemostatic agent with ability to apply pressure on it to achieve hemostasis
- Bleeding severity at the site is minimal, mild, or moderate (SBSS score of 1, 2, or 3)
You will not qualify if you...
- Scheduled for another surgery during follow-up that could affect the use of ETHIZIA or SURGICEL Original
- Taking multiple antithrombotic therapies in therapeutic doses except acetylsalicylic acid
- Active or suspected infection at the bleeding site
- Pregnant, planning pregnancy, or breastfeeding during the 28-day follow-up
- Bleeding site originates from parenchymal organ tissue, cardiovascular tissue, near bone foramina, or bony confined areas
- Bleeding site involves a large arterial or venous defect requiring vascular reconstruction to maintain vessel patency
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Keck Hospital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
2
Washington University Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States, 08534
Actively Recruiting
4
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States, 10065
Actively Recruiting
5
UT Health East Texas EMS Air 1
Tyler, Texas, United States, 75701
Actively Recruiting
6
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
7
UMC Radboud
Nijmegen, Netherlands, 6500HB
Actively Recruiting
Research Team
P
Patricia Schleckser
CONTACT
D
Dr Richard Kocharian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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