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New surgical patch aims to stop bleeding faster in open surgery

NCT ID NCT06664788

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study compares a new product called ETHIZIA to an existing one, SURGICEL, for controlling minor to moderate bleeding during open surgery on the abdomen, chest, or limbs. About 108 adults having planned open surgery will be enrolled. The main goal is to see if ETHIZIA stops bleeding within 3 minutes and keeps it stopped for at least 10 minutes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Capital Health Medical Center - Hopewell

    RECRUITING

    Pennington, New Jersey, 08534, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Keck Hospital of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • New York Presbyterian - Weill Cornell Medical Ctr

    RECRUITING

    New York, New York, 10065, United States

  • UMC Radboud

    RECRUITING

    Nijmegen, 6500HB, Netherlands

  • UT Health East Texas EMS Air 1

    RECRUITING

    Tyler, Texas, 75701, United States

  • Washington University Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

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