New surgical patch aims to stop bleeding faster in open surgery
NCT ID NCT06664788
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
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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
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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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
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
7 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Capital Health Medical Center - Hopewell
RECRUITINGPennington, New Jersey, 08534, United States
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Intermountain Medical Center
RECRUITINGMurray, Utah, 84107, United States
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Keck Hospital of USC
RECRUITINGLos Angeles, California, 90033, United States
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New York Presbyterian - Weill Cornell Medical Ctr
RECRUITINGNew York, New York, 10065, United States
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UMC Radboud
RECRUITINGNijmegen, 6500HB, Netherlands
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UT Health East Texas EMS Air 1
RECRUITINGTyler, Texas, 75701, United States
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Washington University Barnes Jewish Hospital
RECRUITINGSt Louis, Missouri, 63110, United States
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