A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Condition(s) studied
Investigational drug(s) / intervention(s)
ETHIZIA: ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original: SURGICEL Original will be applied to bleeding site intraoperatively.
Study 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
Primary outcome measure(s)
- Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site — Intraoperative (up to 10 minutes)
Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on the SBSS is considered as achieving hemostasis.
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Keck Hospital of USC | Los Angeles | California | |
| Washington University Barnes Jewish Hospital | St Louis | Missouri | |
| Capital Health Medical Center - Hopewell | Pennington | New Jersey | |
| New York Presbyterian - Weill Cornell Medical Ctr | New York | New York | |
| UT Health East Texas EMS Air 1 | Tyler | Texas | |
| Intermountain Medical Center | Murray | Utah | |
| UMC Radboud | Nijmegen | Netherlands |
More Ethicon, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06664788 on ClinicalTrials.gov ↗ ← All trials in the USA