A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorEthicon, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ETHIZIA
DeviceETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original
DeviceSURGICEL Original will be applied to bleeding site intraoperatively.
Treatment groups
108 Participants
are divided into 2 treatment groupsGroup A: ETHIZIAExperimental treatment 1 intervention
Group B: SURGICEL OriginalActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
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.
Time frame
Intraoperative (up to 10 minutes)4
Median Time to Hemostasis at Target Bleeding Site
Median time to hemostasis at target bleeding site will be reported.
Time frame
IntraoperativeSponsors and contacts
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Source ClinicalTrials.gov