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

Part of paid clinical trials in Torrance, California.

Sponsor
Corza Medical GmbH
Study ID
NCT06664775
Phase
PHASE3
Status
Recruiting

Conditions

  • Hemorrhage

Eligibility Criteria

Sex
ALL
Age
1 Month - N/A
Healthy Volunteers
Not accepted

Interventions

  • TachoSil — BIOLOGICAL
    Adjunct to hemostasis
  • Surgicel Original — BIOLOGICAL
    Adjunct to hemostasis

Study Details

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.

Key Dates

Start date
Apr 2, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TachoSil
  • Active Comparator: Surgicel Original

Primary Outcome Measure

Hemostatic success within 3 minutes [ Time Frame: within 3 minutes of study intervention ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Torrance MemorialTorranceCalifornia90505-
St. Anthony HospitalLakewoodColorado80228-
Georgetown UniversityWashington D.C.District of Columbia20007-
University Of ChicagoChicagoIllinois60637-
Indiana UniversityIndianapolisIndiana46202-
University of LouisvilleLouisvilleKentucky40202-
Washington UniversitySt LouisMissouri63110-
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28203-
The Ohio State University Medical CenterColumbusOhio43210-

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