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RECRUITING
NCT06664775
PHASE3

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

Sponsor: Corza Medical GmbH

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

1 Month - Any

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2025-04-02

Completion Date

2026-06-30

Last Updated

2025-10-06

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

TachoSil

Adjunct to hemostasis

BIOLOGICAL

Surgicel 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