Recruiting

ETHIZIA vs. SURGICEL

Sponsor:

Ethicon, Inc.

Code:

NCT06664788

Conditions

Hemostasis

Hemostatic Techniques

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

ETHIZIA

SURGICEL Original

Study Details

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

Study ID

NCT06664788

Start date

Apr 16, 2025

Status verified date

Aug, 2026

Completion date

Sep 28, 2026

Anticipated

Primary completion date

Sep 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

ETHIZIA

ETHIZIA patch will be applied to bleeding site intraoperatively.

SURGICEL Original

SURGICEL Original will be applied to bleeding site intraoperatively.

Primary outcome measure

  • 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 [ Time Frame: Intraoperative (up to 10 minutes) ]

Central Contacts and Locations

Central contacts

Patricia Schleckser

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

Dr Richard Kocharian

+16096423787rkochar1@its.jnj.com

Locations

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Washington University Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Capital Health Medical Center - Hopewell

Recruiting

Pennington, New Jersey, United States, 08534

New York Presbyterian - Weill Cornell Medical Ctr

Recruiting

New York, New York, United States, 10065

UT Health East Texas EMS Air 1

Recruiting

Tyler, Texas, United States, 75701

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

More Information

Sponsor

Ethicon, Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ethicon, Inc. on 2026-08-28.