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A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Sponsor: Ethicon, Inc.
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.
Official title: A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2025-04-16
Completion Date
2026-04-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
ETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.
Locations (8)
Keck Hospital of USC
Los Angeles, California, United States
Washington University Barnes Jewish Hospital
St Louis, Missouri, United States
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States
UT Health East Texas EMS Air 1
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
UMC Radboud
Nijmegen, Netherlands
UMC Radboud
Nijmegen, Netherlands