Trials / Recruiting
RecruitingNCT06664775
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
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.
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- Sponsor
- Corza Medical GmbH · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TachoSil | Adjunct to hemostasis |
| BIOLOGICAL | Surgicel Original | Adjunct to hemostasis |
Timeline
- Start date
- 2025-04-02
- Primary completion
- 2026-03-31
- Completion
- 2026-06-30
- First posted
- 2024-10-30
- Last updated
- 2025-10-06
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06664775. Inclusion in this directory is not an endorsement.