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

Launched by ETHICON, INC. · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new product called ETHIZIA to see how well it stops soft tissue bleeding during different types of open surgeries compared to a standard product called SURGICEL Original. The main goal is to find out how effective each product is at controlling bleeding quickly, specifically looking at the number of cases where bleeding stops within 3 minutes and does not start again within 10 minutes.

To participate in this trial, individuals must be scheduled for certain elective surgeries and have a specific bleeding site that is not easily manageable with standard methods like stitches or heat. Candidates should also be able to provide written consent and meet other health criteria, such as not having an active infection at the bleeding site. During the trial, participants can expect close monitoring during their surgery and follow-up to track how well the bleeding is controlled. It's important to know that this trial is not yet recruiting participants, so there may be a wait before it starts.

Gender

ALL

Eligibility 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