RecruitingNot ApplicableNCT06664788

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

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


Sponsor

Ethicon, Inc.

Enrollment

108 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ETHIZIA and a medical device called SURGICEL Original for people with hemostasis and hemostatic techniques. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEETHIZIA

ETHIZIA patch will be applied to bleeding site intraoperatively.

DEVICESURGICEL Original

SURGICEL Original will be applied to bleeding site intraoperatively.


Locations(7)

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

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NCT06664788


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