NCT06664788

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Ethicon, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemostasis
• Hemostatic Techniques

Interventions

Type	Name	Description
DEVICE	ETHIZIA	ETHIZIA patch will be applied to bleeding site intraoperatively.
DEVICE	SURGICEL Original	SURGICEL Original will be applied to bleeding site intraoperatively.

Timeline

• Start date: 2025-04-16
• Primary completion: 2026-03-31
• Completion: 2026-04-30
• First posted: 2024-10-30
• Last updated: 2026-04-13

Locations

8 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study