The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
111
Single use, intra-operative application to the target bleeding site
A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose
Occurrence of adverse events (AEs)/ adverse device effects (ADEs)
Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.
Time frame: ≤30 ± 5 days/ end-of-study visit after device application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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...and 14 more locations