A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
NCT ID: NCT06664788
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
108 participants
INTERVENTIONAL
2025-04-16
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ETHIZIA
ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed up for 28 days after surgery.
ETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original
SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed-up for 28 days after surgery.
SURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.
Interventions
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ETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ethicon Inc. Clinical Trial
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Keck Hospital of USC
Los Angeles, California, United States
Washington University Barnes Jewish Hospital
St Louis, Missouri, United States
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States
UT Health East Texas EMS Air 1
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
UMC Radboud
Nijmegen, , Netherlands
UMC Radboud
Nijmegen, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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BIO202401
Identifier Type: OTHER
Identifier Source: secondary_id
BIO202401
Identifier Type: -
Identifier Source: org_study_id