A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.

Celstat [NCT02640235]

Description: The study is to evaluate the effectiveness and safety of CELSTAT vs active control.

Device: CELSTAT; Device: Surgicel Original

Primary Investigator: Answini

Drug/Device Information
To evaluate the effectiveness and safety of Celstat as an adjunct to hemostasis for tissue bleeding in cardiothoracic, general and vascular surgery
Celstat Absorbable Hemostat is an oxidized cellulose strip
Randomized 1:1 to Celstat vs. Surgicel Original
Baxter Healthcare Corporation
Major Inclusion and Exclusion
Planned (non-emergency) cardiothoracic, general or vascular surgery
Bleeding scale Grade 1 or 2 (mild or moderate) soft tissue, vascular, or parenchymal bleeding present after standard conventional surgical hemostatic methods prove to be ineffective or impractical
No congenital coagulation disorder
Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of a TBS (target bleeding site)
Disseminated intravascular coagulopathy
Application of any topical hemostatic product to the TBS prior to application of the study treatment