An interventional study of ETHIZIA and SURGICEL Original in Hemostasis and Hemostatic Techniques, sponsored by Ethicon, Inc.. Completed at 7 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Ethicon, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment
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.
Ethicon, Inc. is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pre-operative
Intra-operative
Exclusion Criteria:
Pre-operative
Intra-operative
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ETHIZIA will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed up for 28 days after surgery.
Device: ETHIZIA
SURGICEL Original will be applied at bleeding sites that meet the inclusion criteria in participants undergoing open surgery to control soft tissue bleeding. Participants will be followed-up for 28 days after surgery.
Device: SURGICEL Original
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL Original will be applied to bleeding site intraoperatively.
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.
Time 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
Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Data sharing details ↗ · innovativemedicine.jnj.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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