RECRUITING

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

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Conditions

HemostasisHemostatic Techniques

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-16
Study Completion:2026-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06664788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure
  2. * Participant is willing and able to give written informed consent for the clinical investigation participation Intra-operative
  3. * 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
  4. * 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
  5. * 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
  6. * Participant has a Target Bleeding Site with a SBSS score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities)
  1. * Participant is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL Original application
  2. * Participant is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid
  3. * Participant has an active or suspected infection at the bleeding site
  4. * Participant is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period Intra-operative
  5. * 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
  6. * Target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency

Contacts and Locations

Study Contact

Study Contact
CONTACT
+1 609 6423787
rkochar1@its.jnj.com
Patricia Schleckser
CONTACT
+1 908 808 6670
pschleck@its.jnj.com

Principal Investigator

Ethicon Inc. Clinical Trial
STUDY_DIRECTOR
Ethicon, Inc.

Study Locations (Sites)

Keck Hospital of USC
Los Angeles, California, 90033
United States
Washington University Barnes Jewish Hospital
Saint Louis, Missouri, 63110
United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, 10065
United States
Intermountain Medical Center
Murray, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Ethicon, Inc.

  • Ethicon Inc. Clinical Trial, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2026-03-01

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2026-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Hemostasis
  • Hemostatic Techniques