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

Purpose

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.

Condition

  • Hemorrhage

Eligibility

Eligible Ages
Over 1 Month
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TachoSil
  • Biological: TachoSil
    Adjunct to hemostasis
Active Comparator
Surgicel Original
  • Biological: Surgicel Original
    Adjunct to hemostasis

Recruiting Locations

Georgetown University
Washington D.C. 4140963, District of Columbia 4138106 20007

More Details

Status
Recruiting
Sponsor
Corza Medical GmbH

Study Contact

Jeff Wilson
1 416-578-9058
Jeff.wilson@corza.com