Actively Recruiting
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
Led by Ethicon, Inc. · Updated on 2026-06-05
108
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the ETHIZIA patch compared to SURGICEL Original for controlling minimal, mild, or moderate soft tissue bleeding during open surgeries. The study focuses on surgeries involving the abdomen, retroperitoneal area, pelvis, thoracic region (excluding heart surgery), and extremities. The goal is to see which device better achieves bleeding control within 3 minutes after application and prevents re-bleeding up to 10 minutes later. Participants will be randomly assigned to receive either the ETHIZIA patch or SURGICEL Original applied directly to bleeding soft tissue sites during surgery. Both treatments are applied intraoperatively at bleeding sites where conventional methods like sutures or cautery are not effective or practical. After surgery, participants will be followed for 28 days to monitor outcomes and any potential complications. During the study, researchers will closely monitor bleeding control at the target site, measuring the percentage of cases achieving hemostasis at 3 minutes and the absence of re-bleeding up to 10 minutes after application. Additional assessments include timing how quickly bleeding stops, rates of re-bleeding, and the need for additional applications or surgical intervention. Safety and efficacy will be observed through these measures and follow-up visits over the 28-day post-surgery period.
CONDITIONS
Brief Title
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Investigator can identify and visualize a target bleeding site where conventional hemostasis methods are ineffective or impractical
- Target bleeding site originates from soft tissue, including organ bed, loose areolar tissue, fat, lymphatic tissue/lymph node beds, or muscle
- Decision made to use a hemostatic agent with the ability to apply pressure on it to achieve hemostasis
- Target bleeding site has a bleeding severity score of 1, 2, or 3, indicating minimal, mild, or moderate bleeding
You will not qualify if you...
- Participant is scheduled for another planned surgery within the follow-up period that would affect the application of ETHIZIA or SURGICEL Original
- Participant is taking multiple antithrombotic therapies in therapeutic doses except for acetylsalicylic acid
- Participant has an active or suspected infection at the bleeding site
- Participant is pregnant, planning to become pregnant, or breastfeeding during the 28-day follow-up
- Target bleeding site originates from parenchymal organ tissue, cardiovascular tissue, near bone foramina, or bony confined areas
- Target bleeding site is from a large artery or vein defect requiring vascular reconstruction with vessel patency maintenance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery duration plus immediate intraoperative period (up to 10 minutes)
Participants undergo open surgery during which either the ETHIZIA or SURGICEL Original device is applied to control soft tissue bleeding at the target bleeding site.
1 surgical procedure visit (in-person)
Duration - 28 days
Participants are monitored for safety and efficacy outcomes for 28 days after surgery.
Follow-up visits during 28 days after surgery
Trial Site Locations
Total: 7 locations
1
Keck Hospital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
2
Washington University Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Capital Health Medical Center - Hopewell
Pennington, New Jersey, United States, 08534
Actively Recruiting
4
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States, 10065
Actively Recruiting
5
UT Health East Texas EMS Air 1
Tyler, Texas, United States, 75701
Actively Recruiting
6
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
7
UMC Radboud
Nijmegen, Netherlands, 6500HB
Actively Recruiting
Research Team
P
Patricia Schleckser
D
Dr Richard Kocharian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here