NCT06664775 · Corza Medical GmbH
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
What this study is about
The purpose of this clinical study is to assess the effectiveness 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Elective open abdominal, retroperitoneal, pelvic, or thoracic surgery. Elective transplant surgery except for liver or heart transplants is included.
- 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.
- Presence of an appropriate mild to moderate bleeding soft tissue TBS identified intra-operatively by the surgeon.
- The TBS size \< 21 cm2/3.3 in2.
- Ability to firmly press study intervention at TBS until 3 minutes after randomization.
Exclusion criteria
- Participants undergoing cardiovascular, hepatic, and laparoscopic and robotic surgeries.
- Congenital or acquired disorders of coagulation.
- Diseases requiring constant use of any anticoagulant drugs that cannot be safely washed out prior to randomization.
- Screening Hemoglobin \< 9 mg/dL, platelets \< 75 × 103/µL, and/or international normalized ratio (INR) \> 1.5.
- Acute major bleeding during surgery.
- Participant with TBS in an actively infected field.
- Target bleeding site is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency.
- Target bleeding site with major arterial bleeding requiring suture or mechanical ligation.
- Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.
- Participants with Grade '0', '3', and '4' bleeding at TBS according to VIBe Scale.
Where
- Torrance, California
- Lakewood, Colorado
- Washington D.C., District of Columbia
- Chicago, Illinois
- Indianapolis, Indiana
- Louisville, Kentucky
- St Louis, Missouri
- Charlotte, North Carolina
- Columbus, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations