RecruitingPhase 3NCT06664775

A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery

An Open Label, Prospective, Randomized, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of TachoSil® Versus Surgicel™ Original (Oxidized Regenerated Cellulose) as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During Surgery.

Sponsor

Corza Medical GmbH

Enrollment

116 participants

Start Date

Apr 2, 2025

Study Type

INTERVENTIONAL

Conditions

Hemorrhage

Summary

The purpose of this clinical study is to assess the efficacy and safety of TachoSil compared to the widely known and used for \> 60 years local hemostatic product Surgicel Original as an adjunct to control mild to moderate soft tissue bleeding during surgery.

Eligibility

Min Age: 1 Month

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Surgicel Original and a biological treatment called TachoSil for people with hemorrhage. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 1 Month 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

BIOLOGICALTachoSil

Adjunct to hemostasis

BIOLOGICALSurgicel Original

Adjunct to hemostasis

Locations(9)

Torrance Memorial

Torrance, California, United States

St. Anthony Hospital

Lakewood, Colorado, United States

Georgetown University

Washington D.C., District of Columbia, United States

University Of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Louisville

Louisville, Kentucky, United States

Washington University

St Louis, Missouri, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06664775

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