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

Not Applicable

Not yet recruiting

• Conditions: Hemostasis; Hemostatic Techniques

• Registration Number: NCT06664788
• Lead Sponsor: Ethicon, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Study First Posted: 2024-10-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28
• Study Start: 2025-04-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding At 10 Minutes Following Application at The Target Bleeding Site	Intraoperative (up to 10 minutes)	Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding at 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.

Secondary Outcome Measures

Name	Time	Method
Time to Hemostasis at Target Bleeding Site	Intraoperative (up to 10 minutes)	Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution.
Median Time to Hemostasis at Target Bleeding Site	Intraoperative	Median time to hemostasis at target bleeding site will be reported.
Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding At 10 Minutes Following Application at All Treated Bleeding Sites	Intraoperative (up to 10 minutes)	Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding at 10 minutes following application at all bleeding sites (additional bleeding sites treated including target bleeding site) will be determined by 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.
Time to Hemostasis for All Bleeding Sites	Intraoperative (up to 10 minutes)	Time to achieve hemostasis for all bleeding sites for up to 10 minutes will be evaluated using Kaplan-Meier.
Median Time to Hemostasis for All Bleeding Sites	Intraoperative	Median time to hemostasis for all treated bleeding sites will be reported for both groups.
Number of Participants with Treatment Failure	Intraoperative (up to 10 minutes)	Treatment failure is defined as no hemostasis at 10 minutes. Participants that received rescue treatment or experienced a rebleed between 3 minutes and 10 minutes will be considered a treatment failure.
Percentage of Treated Bleeding Sites with Rebleeding After 10 Minutes	Intraoperative	Percentage of treated bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure will be reported.
Percentage of Participants Achieving Hemostasis with ETHIZIA or SURGICEL Original	At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds	Hemostasis is defined by a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale (SBSS).
Proportion of Treated Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis	Intraoperative	Proportion of treated bleeding sites requiring more than one application of randomized product in order to achieve hemostasis will be reported.
Proportion of Participants who Require More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis	Intraoperative	Proportion of participants requiring more than one application of randomized product in order to achieve hemostasis will be reported.
Proportion of Treated Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis	Intraoperative	Proportion of treated bleeding sites that require a second surgical maneuver (e.g. additional pressure, adjunct product, electrocautery, etc.) as a rescue treatment to achieve hemostasis following treatment will be reported.
Proportion of Participants who Require a Second Surgical Maneuver to Achieve Hemostasis	Intraoperative	Proportion of participants who require a second surgical maneuver (e.g. additional pressure, adjunct product, electrocautery, etc.) as a rescue treatment to achieve hemostasis following treatment will be reported.

Trial Locations

Locations (5)

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

Washington University Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

New York Presbyterian - Weill Cornell Medical Ctr; 🇺🇸 New York, New York, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

UMC Radboud; 🇳🇱 Nijmegen, Netherlands