A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery (OCEAN)

NCT01637025 NA COMPLETED

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®)

Details

Lead sponsor	Baxter Healthcare Corporation
Phase	NA
Status	COMPLETED
Enrolment	111
Start date	2012-05
Completion	2012-11

Conditions

• Intra-operative Bleeding

Interventions

• Oxidized cellulose strip
• Oxidized regenerated cellulose strip

Primary outcomes

• Occurrence of adverse events (AEs)/ adverse device effects (ADEs) — ≤30 ± 5 days/ end-of-study visit after device application
  Occurrence of adverse events (AEs)/ adverse device effects (ADEs) up to 30 ± 5 days/ end-of-study visit after device application.

Countries

Czechia, Germany, Hungary, Poland