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.

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage
• Intervention / Treatment: Biological: TachoSil; Biological: Surgicel Original

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jeff Wilson; Phone Number: 1 416-578-9058; Email: Jeff.wilson@corza.com
• Study Contact Backup: Name: Michele Young; Phone Number: 1 689-316-8809; Email: Michele.young@corza.com

Study Locations

• United States
  • California
    • Torrance, California, United States, 90505
      • Recruiting
      • Torrance Memorial
  • Colorado
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • St. Anthony Hospital
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • Georgetown University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Atrium Health Carolinas Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
2. The participant has a need for secondary hemostatic study intervention at the TBS with mild to moderate bleeding Grade 1 and Grade 2 according to the VIBe Scale.
3. Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
4. The TBS size < 21 cm2/3.3 in2.
5. Ability to firmly press study intervention at TBS until 3 minutes after randomization.

Exclusion Criteria:

1. Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
2. Congenital or acquired disorders of coagulation.
3. Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
4. Screening Hemoglobin < 9 mg/dL, platelets < 75 × 103/µL, and/or international normalized ratio (INR) > 1.5.
5. Acute major bleeding during surgery.
6. Participant with TBS in an actively infected field.
7. Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
8. Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
9. Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
10. Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TachoSil	Biological: TachoSil; Adjunct to hemostasis
Active Comparator: Surgicel Original	Biological: Surgicel Original; Adjunct to hemostasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostatic success within 3 minutes	Proportion of participants achieving hemostatic success at the target bleeding site (TBS) within 3 minutes after application of study intervention	within 3 minutes of study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemostatic success within 6 minutes	Proportion of participants achieving hemostatic success within 6 minutes after application of study intervention	within 6 minutes of study intervention
Study intervention failures	Proportion of study intervention failures, defined as failure to achieve hemostatic success within 6 minutes after application of study intervention or bleeding requiring additional intervention during the 6 minutes after application of study intervention	within 6 minutes of study intervention
hemostatic success from moderate bleeding within 3 minutes	Proportion of participants with moderate bleeding achieving hemostatic success at the TBS within 3 minutes after application of study intervention	within 3 minutes of study intervention

Collaborators and Investigators

• Sponsor: Corza Medical GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; TachoSil
• Other Study ID Numbers: CM-TS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No