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

NCT06664788 | Recruiting DMC FDA Device

• 1 other identifier: BIO202401
• Study Type: interventional
• Target: 108
• Locations: 2 countries
• Sites: 8

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.

Conditions

Hemostasis; Hemostatic Techniques

Outcome Measures

Primary Outcomes (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

  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 Outcomes (11)

• Time to Hemostasis at Target Bleeding Site

  Intraoperative (up to 10 minutes)

• 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

  Intraoperative (up to 10 minutes)

• Time to Hemostasis for All Treated Bleeding Sites

  Intraoperative (up to 10 minutes)

• Median Time to Hemostasis at Target Bleeding Site

  Intraoperative

• Median Time to Hemostasis for All Treated Bleeding Sites

  Intraoperative

Study Arms (2)

ETHIZIA

EXPERIMENTAL

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

SURGICEL Original

ACTIVE COMPARATOR

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

Interventions

SURGICEL Original DEVICE

SURGICEL Original will be applied to bleeding site intraoperatively.

SURGICEL Original

ETHIZIA DEVICE

ETHIZIA patch will be applied to bleeding site intraoperatively.

ETHIZIA

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

Washington University Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Capital Health Medical Center - Hopewell

Pennington, New Jersey, 08534, United States

RECRUITING

New York Presbyterian - Weill Cornell Medical Ctr

New York, New York, 10065, United States

RECRUITING

UT Health East Texas EMS Air 1

Tyler, Texas, 75701, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

UMC Radboud

Nijmegen, 6500HB, Netherlands

RECRUITING

UMC Radboud 1

Nijmegen, 6500, Netherlands

NOT YET RECRUITING

Study Officials

• Ethicon Inc. Clinical Trial

  Ethicon, Inc.

  STUDY DIRECTOR

Central Study Contacts

Patricia Schleckser

CONTACT

+1 908 808 6670; pschleck@its.jnj.com

Dr Richard Kocharian

CONTACT

+16096423787; rkochar1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: April 16, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (6); NL (2)