Skip to content
Bored Studies
RecruitingPhase 3

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

Corza Medical GmbH · NCT06664775

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1 mo+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
116
US sites recruiting
9
Study start
April 2, 2025
Record last updated
June 30, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: TachoSil; Surgicel Original

Conditions: Hemorrhage

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

Study contacts (from the official record)

  • Jeff Wilson · 1 416-578-9058 · Jeff.wilson@corza.com
  • Michele Young · 1 689-316-8809 · Michele.young@corza.com
A Study to Compare the Efficacy and Safety of TachoSil and… (NCT06664775) | Bored Studies