Comparing ETHIZIA and SURGICEL for controlling bleeding during 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
This study is testing whether a new product called ETHIZIA can stop bleeding better than SURGICEL during certain surgeries for patients who have soft tissue bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 108 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Ethicon, Inc. Industry-sponsored |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT06664788 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and efficacy of ETHIZIA in controlling soft tissue bleeding during open surgeries compared to SURGICEL Original. The study focuses on patients undergoing elective surgical procedures where conventional hemostatic methods are ineffective. It measures the percentage of cases achieving hemostasis at 3 minutes post-application and assesses re-bleeding rates up to 10 minutes after application. Participants will have identifiable bleeding sites from soft tissue with varying severities.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective open surgeries with minimal to moderate soft tissue bleeding.
Not a fit: Patients with severe bleeding or those not undergoing elective surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective hemostatic agent for controlling bleeding during surgeries, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown success with similar hemostatic agents, indicating a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 6 other locations
- Keck Hospital of USC — Los Angeles, California, United States (Recruiting)
- Washington University Barnes Jewish Hospital — St Louis, Missouri, United States (Recruiting)
- Capital Health Medical Center - Hopewell — Pennington, New Jersey, United States (Recruiting)
- New York Presbyterian - Weill Cornell Medical Ctr — New York, New York, United States (Recruiting)
- UT Health East Texas EMS Air 1 — Tyler, Texas, United States (Recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- UMC Radboud — Nijmegen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Patricia Schleckser
- Email: pschleck@its.jnj.com
- Phone: +1 908 808 6670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.