HemostasisNCT06664788
A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery
A study testing ETHIZIA and SURGICEL Original in people with Hemostasis and Hemostatic Techniques, run by Ethicon, Inc. at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hemostasis, Hemostatic Techniques
- What is being tested?
- ETHIZIA and SURGICEL Original
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 16 Apr 2025to 7 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Keck Hospital of USC
Los Angeles, California, 90033
Intermountain Medical Center
Murray, Utah, 84107
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, 10065
Capital Health Medical Center - Hopewell
Pennington, New Jersey, 08534
Washington University Barnes Jewish Hospital
St Louis, Missouri, 63110
UT Health East Texas EMS Air 1
Tyler, Texas, 75701
About this study
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
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.
- Conditions
- Hemostasis, Hemostatic Techniques
- Being tested
- ETHIZIA, SURGICEL Original
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETHIZIADevice
ETHIZIA patch will be applied to bleeding site intraoperatively.
SURGICEL OriginalDevice
SURGICEL Original will be applied to bleeding site intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| ETHIZIA | Experimental | 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. Receives: Device: ETHIZIA |
| SURGICEL Original | Active comparator | 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. Receives: Device: SURGICEL Original |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (up to 10 minutes)
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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.
Measured: Intraoperative (up to 10 minutes)
Median Time to Hemostasis at Target Bleeding Site
Median time to hemostasis at target bleeding site will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start16 Apr 2025
- Primary completion3 Sep 2026
- Study completion7 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ethicon Inc. Clinical Trial, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664788
- Sponsor's protocol ID
- BIO202401
- Other IDs
- BIO202401
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06664788
- Acronym / sponsor ID
- BIO202401
- Conditions
- Hemostasis, Hemostatic Techniques
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2025 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 7 Oct 2026 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETHIZIA | Experimental | Device: ETHIZIAETHIZIA 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. |
| SURGICEL Original | Active comparator | Device: SURGICEL OriginalSURGICEL 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETHIZIAETHIZIA patch will be applied to bleeding site intraoperatively. | Device | ETHIZIA |
| SURGICEL OriginalSURGICEL Original will be applied to bleeding site intraoperatively. | Device | SURGICEL Original |
Primary outcome
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
Time frame: Intraoperative (up to 10 minutes)
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.
11 secondary outcomes
Time to Hemostasis at Target Bleeding Site
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
Time frame: Intraoperative (up to 10 minutes)
Time to Hemostasis for All Treated Bleeding Sites
Time frame: Intraoperative (up to 10 minutes)
Median Time to Hemostasis at Target Bleeding Site
Time frame: Intraoperative
Median Time to Hemostasis for All Treated Bleeding Sites
Time frame: Intraoperative
Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites
Time frame: Intraoperative (up to 10 minutes)
Sustained Hemostasis at All Treated Bleeding Sites
Time frame: Intraoperative
Proportion of Bleeding Sites with Rebleeding After 10 Minutes
Time frame: Intraoperative
Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original
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
Time frame: Intraoperative
Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethicon Inc. Clinical Trial study director
Ethicon, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETHIZIA and SURGICEL Original in people with Hemostasis and Hemostatic Techniques, run by Ethicon, Inc. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Intraoperative (up to 10 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.