Clinical trial NCT06664788: A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemostasis
Hemostatic Techniques
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 108
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding At 10 Minutes Following Application at The Target Bleeding Site
timeFrame: Intraoperative (up to 10 minutes)
Secondary outcomes:
measure: Time to Hemostasis at Target Bleeding Site
timeFrame: Intraoperative (up to 10 minutes)
measure: Median Time to Hemostasis at Target Bleeding Site
timeFrame: Intraoperative
measure: Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding At 10 Minutes Following Application at All Treated Bleeding Sites
timeFrame: Intraoperative (up to 10 minutes)
measure: Time to Hemostasis for All Bleeding Sites
timeFrame: Intraoperative (up to 10 minutes)
measure: Median Time to Hemostasis for All Bleeding Sites
timeFrame: Intraoperative
measure: Number of Participants with Treatment Failure
timeFrame: Intraoperative (up to 10 minutes)
measure: Percentage of Treated Bleeding Sites with Rebleeding After 10 Minutes
timeFrame: Intraoperative
measure: Percentage of Participants Achieving Hemostasis with ETHIZIA or SURGICEL Original
timeFrame: At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds
measure: Proportion of Treated Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis
timeFrame: Intraoperative
measure: Proportion of Participants who Require More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis
timeFrame: Intraoperative
measure: Proportion of Treated Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis
timeFrame: Intraoperative
measure: Proportion of Participants who Require a Second Surgical Maneuver to Achieve Hemostasis
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Saint Louis
country: United States
facility: Washington University Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: New York Presbyterian - Weill Cornell Medical Ctr
state: New York
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Nijmegen
country: Netherlands
facility: UMC Radboud
Study officials:
affiliation: Ethicon, Inc.
name: Ethicon Inc. Clinical Trial
role: STUDY_DIRECTOR
References: