Comparing TachoSil and Surgicel Original to control mild-to-moderate soft tissue bleeding during open 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.

This test compares TachoSil and Surgicel Original to see which stops mild-to-moderate soft tissue bleeding better during certain elective open surgeries.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 1 Month and up
• Sex: All
• Sponsor: Corza Medical GmbH (Industry-sponsored)
• Locations: 9 sites (Torrance, California and 8 other locations)
• Trial ID: NCT06664775 on ClinicalTrials.gov

What this trial studies

In this Phase 3 interventional trial, patients undergoing elective open abdominal, retroperitoneal, pelvic, or thoracic surgery who develop a small area of mild-to-moderate soft tissue bleeding are treated intraoperatively with one of two local hemostatic products. The bleeding target site (TBS) must be under 21 cm2 and meet Grade 1–2 on the VIBe scale, and the assigned product is applied and pressed for up to three minutes after randomization. The study compares clinical hemostasis effectiveness and safety outcomes between TachoSil and Surgicel Original. Patients with cardiovascular, hepatic, laparoscopic/robotic procedures, significant coagulation disorders, or acute major bleeding are excluded.

Who should consider this trial

Good fit: Ideal candidates are adults having elective open abdominal, retroperitoneal, pelvic, or thoracic surgery who develop an intraoperative mild-to-moderate soft tissue bleed suitable for a local hemostatic patch measuring under 21 cm2 and that can be pressed for three minutes.

Not a fit: Patients having cardiovascular, hepatic, laparoscopic, or robotic procedures, those with coagulation disorders or unmodifiable anticoagulation, very low hemoglobin/platelets, high INR, or acute major bleeding are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could identify a more effective or safer local hemostatic option to reduce bleeding, shorten operative time, and lower complication risk.

How similar studies have performed: Both TachoSil and Surgicel have prior clinical use and supporting studies for local hemostasis, but direct head-to-head comparisons in this specific setting are relatively limited.

Eligibility criteria

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.

Where this trial is running

Torrance, California and 8 other locations

• Torrance Memorial — Torrance, California, United States (Recruiting)
• St. Anthony Hospital — Lakewood, Colorado, United States (Recruiting)
• Georgetown University — Washington D.C., District of Columbia, United States (Recruiting)
• University Of Chicago — Chicago, Illinois, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Recruiting)
• University of Louisville — Louisville, Kentucky, United States (Recruiting)
• Washington University — St Louis, Missouri, United States (Recruiting)
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (Recruiting)
• The Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Jeff Wilson

Conditions Hemorrhage