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
NCT06664775 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2025-10-06
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
- BIOLOGICAL
-
TachoSil
Adjunct to hemostasis
- BIOLOGICAL
-
Surgicel Original
Adjunct to hemostasis
Sponsors & Collaborators
-
Corza Medical GmbH
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Month
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-02
- Primary Completion
- 2026-03-31
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
NCT04660721 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effectiveness and Safety of CELSTAT for Hemostasis in Intraoperative Tissue Bleeding
NCT02640235 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
NCT03654560 ·Status: COMPLETED ·Phase: NA
-
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)
NCT00546169 ·Status: COMPLETED
-
A Study of Fibrocaps™ in Surgical Bleeding
NCT01527357 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of WoundClot Surgical
NCT06696092 ·Status: COMPLETED ·Phase: NA
-
Oxidized Cellulose hEmostAsis evaluatioN
NCT01637025 ·Status: COMPLETED ·Phase: NA
-
QuikClot Control+ Hemostatic Dressing Use in Mild to Moderate Bleeding
NCT04415606 ·Status: COMPLETED ·Phase: NA
-
Factor Replacement in Surgery
NCT04114643 ·Status: UNKNOWN ·Phase: PHASE2
-
Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery
NCT01475669 ·Status: COMPLETED ·Phase: PHASE3
-
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
NCT05523297 ·Status: COMPLETED ·Phase: PHASE3
-
TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)
NCT00241163 ·Status: COMPLETED ·Phase: PHASE3
-
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Non-cardiac Surgery
NCT06144099 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
NCT03489070 ·Status: COMPLETED ·Phase: PHASE3
-
Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery
NCT02360800 ·Status: COMPLETED ·Phase: NA
-
TachoSil Paediatric Liver Trial (TC-019-IN)
NCT00365248 ·Status: COMPLETED ·Phase: PHASE3
-
The Fibrin Patch Soft Tissue Study
NCT00658723 ·Status: COMPLETED ·Phase: PHASE2
-
Impact of Balanced Crystalloid and Colloid Infusion on Haemostasis in Healthy Male Volunteers
NCT05148650 ·Status: UNKNOWN ·Phase: NA
-
The Severe Soft Tissue Bleeding Study
NCT00977925 ·Status: COMPLETED ·Phase: PHASE3
-
Tranexamic Acid During Cystectomy Trial (TACT)
NCT01869413 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic Surgery
NCT04224116 ·Status: COMPLETED ·Phase: PHASE4
-
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding
NCT02054260 ·Status: UNKNOWN ·Phase: NA
-
Transfusion of Pathogen Reduced Cryoprecipitated Fibrinogen to Expedite Product Availability in Perioperative Bleeding
NCT05711524 ·Status: COMPLETED ·Phase: PHASE4
-
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
NCT03085394 ·Status: TERMINATED ·Phase: PHASE3
-
The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
NCT03433144 ·Status: WITHDRAWN ·Phase: PHASE4