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

A Prospective, Multicenter, Randomized Clinical Investigation Evaluating the Safety and Efficacy of ETHIZIA™ Versus SURGICEL® Original in Controlling Minimal, Mild, or Moderate Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic, Thoracic (Non-cardiac) and Extremity Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Hemostasis; Hemostatic Techniques
• Intervention / Treatment: Device: ETHIZIA; Device: SURGICEL Original

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Schleckser; Phone Number: +1 908 808 6670; Email: pschleck@its.jnj.com
• Study Contact Backup: Name: Dr Richard Kocharian; Phone Number: +16096423787; Email: rkochar1@its.jnj.com

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500HB
    • Recruiting
    • UMC Radboud
• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Keck Hospital of USC
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University Barnes Jewish Hospital
  • New Jersey
    • Pennington, New Jersey, United States, 08534
      • Recruiting
      • Capital Health Medical Center - Hopewell
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian - Weill Cornell Medical Ctr
  • Texas
    • Tyler, Texas, United States, 75701
      • Recruiting
      • UT Health East Texas EMS Air 1
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: ETHIZIA; ETHIZIA patch will be applied to bleeding site intraoperatively.
Active Comparator: 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.	Device: SURGICEL Original; SURGICEL Original will be applied to bleeding site intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Cases achieving hemostasis at 3 minutes following product application & with no rebleeding up to 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.	Intraoperative (up to 10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Hemostasis at Target Bleeding Site	Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution.	Intraoperative (up to 10 minutes)
Median Time to Hemostasis at Target Bleeding Site	Median time to hemostasis at target bleeding site will be reported.	Intraoperative
Time to Hemostasis for All Treated Bleeding Sites	Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated.	Intraoperative (up to 10 minutes)
Median Time to Hemostasis for All Treated Bleeding Sites	Median time to hemostasis for all treated bleeding sites will be reported for both groups.	Intraoperative
Percentage of Bleeding Sites Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at All Treated Bleeding Sites	Percentage of bleeding sites achieving hemostasis at 3 minutes following product application & with no rebleeding up to 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).	Intraoperative (up to 10 minutes)
Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites	Treatment failure is defined as no hemostasis at 10 minutes or received rescue therapy prior to 10 minutes from the application of the study product.	Intraoperative (up to 10 minutes)
Sustained Hemostasis at All Treated Bleeding Sites	Sustained hemostasis at all treated bleeding sites will be reported. Sustained hemostasis is defined as achieving hemostasis at 3 minutes with no rebleeding up to Day 28.	Intraoperative
Proportion of Bleeding Sites with Rebleeding After 10 Minutes	Proportion of bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.	Intraoperative
Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original	Percentage of bleeding sites achieving hemostasis with ETHIZIA or SURGICEL Original will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.	At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds
Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis	Proportion of bleeding sites requiring more than one application of randomized product in order to achieve hemostasis will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.	Intraoperative
Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis	Proportion of bleeding sites that require a second surgical maneuver (for example, adjunct product, electrocautery, etcetera) as a rescue therapy to achieve hemostasis following treatment will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.	Intraoperative

Collaborators and Investigators

• Sponsor: Ethicon, Inc.
• Investigators: Study Director: Ethicon Inc. Clinical Trial, Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2026

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 27, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: BIO202401 (Other Identifier: Ethicon,Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes