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Completed Not applicable

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

NCT06664788 · tracked via the Priya Life Science USA tracker
Phase
Not applicable
Started
2025-04-16
Last updated
2026-11-03

Condition(s) studied

HemostasisHemostatic Techniques

Investigational drug(s) / intervention(s)

ETHIZIASURGICEL Original

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

Sex
ALL
Min age
22 Years
Max age
—
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, defined as organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, and muscle * The choice is made to use a hemostatic agent to stop the bleeding, and there is the ability to apply pressure on the surface of the hemostatic agent to achieve hemostasis * Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities) Exclusion Criteria: Pre-operative * Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application * Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid * Participant has an active or suspected infection at the bleeding site * Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period Intra-operative * Target bleeding site is identified to originate from parenchymal organ tissue, cardiovascular (anastomotic or cardiovascular repair sites) tissue, or is in proximity to a foramina in bone, or areas of bony confine * Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency

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)

FacilityCityRegionStatus
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
Official registry record

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