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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original will be applied to bleeding site intraoperatively.
Keck Hospital of USC
Los Angeles, California, United States
RECRUITINGWashington University Barnes Jewish Hospital
St Louis, Missouri, United States
RECRUITINGCapital Health Medical Center - Hopewell
Pennington, New Jersey, United States
Percentage of Cases Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at The Target Bleeding Site
Cases achieving hemostasis at 3 minutes following product application \& with no rebleeding up to 10 minutes following application at the target bleeding site (first bleeding site treated) will be determined by Surface Bleeding Severity Scale (SBSS). SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening). A grade of 0 (None/Dry) on the SBSS is considered as achieving hemostasis.
Time frame: Intraoperative (up to 10 minutes)
Time to Hemostasis at Target Bleeding Site
Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution.
Time frame: Intraoperative (up to 10 minutes)
Percentage of Bleeding Sites Achieving Hemostasis at Three Minutes Following Product Application And With No Rebleeding Up to 10 Minutes Following Application at All Treated Bleeding Sites
Percentage of bleeding sites achieving hemostasis at 3 minutes following product application \& with no rebleeding up to 10 minutes following application at all bleeding sites (additional bleeding sites treated including target bleeding site) will be determined by SBSS. SBSS provides a clinically validated score for assessment of bleeding at the target site, and consists of 6 scores (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, not immediately life-threatening, 5 = extreme, immediately life-threatening).
Time frame: Intraoperative (up to 10 minutes)
Time to Hemostasis for All Treated Bleeding Sites
Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States
RECRUITINGUT Health East Texas EMS Air 1
Tyler, Texas, United States
RECRUITINGIntermountain Medical Center
Murray, Utah, United States
RECRUITINGUMC Radboud
Nijmegen, Netherlands
RECRUITINGUMC Radboud 1
Nijmegen, Netherlands
NOT_YET_RECRUITINGTime frame: Intraoperative (up to 10 minutes)
Median Time to Hemostasis at Target Bleeding Site
Median time to hemostasis at target bleeding site will be reported.
Time frame: Intraoperative
Median Time to Hemostasis for All Treated Bleeding Sites
Median time to hemostasis for all treated bleeding sites will be reported for both groups.
Time frame: Intraoperative
Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites
Treatment failure is defined as no hemostasis at 10 minutes or received rescue therapy prior to 10 minutes from the application of the study product.
Time frame: Intraoperative (up to 10 minutes)
Sustained Hemostasis at All Treated Bleeding Sites
Sustained hemostasis at all treated bleeding sites will be reported. Sustained hemostasis is defined as achieving hemostasis at 3 minutes with no rebleeding up to Day 28.
Time frame: Intraoperative
Proportion of Bleeding Sites with Rebleeding After 10 Minutes
Proportion of bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Time frame: Intraoperative
Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original
Percentage of bleeding sites achieving hemostasis with ETHIZIA or SURGICEL Original will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Time frame: At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds
Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis
Proportion of bleeding sites requiring more than one application of randomized product in order to achieve hemostasis will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Time frame: Intraoperative
Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis
Proportion of bleeding sites that require a second surgical maneuver (for example, adjunct product, electrocautery, etcetera) as a rescue therapy to achieve hemostasis following treatment will be reported. Summaries will be presented for target bleeding site and for all treated bleeding sites.
Time frame: Intraoperative