A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery
Ethicon, Inc.
Summary
The objective of this clinical investigation is to evaluate the safety and efficacy of ETHIZIA to control minimal, mild, or moderate soft tissue bleeding during open surgery when compared to SURGICEL Original in the percentage of cases achieving hemostasis at 3 minutes after product application, and without re-bleeding up to 10 minutes after application.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Pre-operative * Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure * Participant is willing and able to give written informed consent for the clinical investigation participation Intra-operative * Participant in whom the Investigator can identify and visualize a target bleeding site for which any applicable conventional means for hemostasis (e.g., suture, ligature, or cautery) are ineffective or impractical * Target Bleeding Site is identified to originate from soft tissue, def…
Interventions
- DeviceETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
- DeviceSURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.
Locations (7)
- Keck Hospital of USCLos Angeles, California
- Washington University Barnes Jewish HospitalSt Louis, Missouri
- Capital Health Medical Center - HopewellPennington, New Jersey
- New York Presbyterian - Weill Cornell Medical CtrNew York, New York
- UT Health East Texas EMS Air 1Tyler, Texas
- Intermountain Medical CenterMurray, Utah