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A Study of ETHIZIA Versus SURGICEL Original for Bleeding During Open Surgery

This study is looking at how well a medical device called ETHIZIA works to control bleeding during open surgery, compared to another device called SURGICEL Original. The goal is to see if ETHIZIA can stop bleeding within 3 minutes and prevent it from starting again for up to 10 minutes. You could be eligible if you are scheduled for certain types of open surgery (abdominal, back, pelvic, chest, or limb surgery) and are at least 22 years old. The study aims to enroll 108 participants. The current status of this study is unclear.

Study design
This study is comparing two medical devices, ETHIZIA and SURGICEL Original, in 108 participants during surgery.
What's involved
If you participate, either ETHIZIA or SURGICEL Original will be applied to a bleeding site during your surgery.
Compensation
Not stated in the trial record.
Follow-up
The study measures whether bleeding stops and doesn't restart for up to 10 minutes after the product is applied during surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06664788

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

Recruiting
NAAges 22+InterventionalTreatment
Ethicon, Inc.
~108 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ETHIZIASURGICEL Original

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Intraoperative (up to 10 minutes)

Conditions

Hemostasis
Hemostatic Techniques

Explore related trials

HemostasisHemostatic Techniques

Where it's being run

7 sites across 7 states
California1
Missouri1
New Jersey1
New York1
Texas1
Utah1
Netherlands1

Study leadership

  • Ethicon Inc. Clinical Trial · STUDY_DIRECTOR · Ethicon, Inc.

Who to contact

Patricia Schleckser
[email protected]
+1 908 808 6670
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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
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

What this trial measures

  • 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 SiteIntraoperative (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.