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RECRUITING
NCT06664788
NA

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

Sponsor: Ethicon, Inc.

View on ClinicalTrials.gov

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

Interventions

DEVICE

ETHIZIA

ETHIZIA patch will be applied to bleeding site intraoperatively.

DEVICE

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