Study Comparing ETHIZIA and SURGICEL Original Devices to Control Soft Tissue Bleeding During Open Surgeries in Abdomen, Pelvis, Thorax, and Limbs

What this Trial Is About

This research aims to evaluate the safety and effectiveness of a medical device called ETHIZIA compared to SURGICEL Original for controlling minimal, mild, or moderate soft tissue bleeding during open surgery. The study focuses on bleeding that occurs in areas such as the abdomen, pelvis, thorax excluding the heart, and extremities, where standard methods to stop bleeding are ineffective or impractical. Participants will be randomly assigned to receive either the ETHIZIA patch or SURGICEL Original applied directly to the bleeding site during surgery. Both devices are intended to stop bleeding by achieving hemostasis within 3 minutes and without rebleeding up to 10 minutes after application. After the surgery, participants will be monitored and followed up for 28 days. During the study, participants will undergo assessments to measure the percentage of cases achieving hemostasis at the target bleeding site and the time taken to stop bleeding. Additional evaluations include monitoring for rebleeding, treatment failures, and the need for additional applications or surgical maneuvers. Safety and efficacy data will be collected up to 10 minutes intraoperatively and through follow-up visits within 28 days after surgery.

A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery