A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery (NCT06664788) | Clinical Trial Compass
RecruitingNot Applicable
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
United States108 participantsStarted 2025-04-16
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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, …
What they're measuring
1
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