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| ID | Type | Description | Link |
|---|---|---|---|
| BIO202401 | Other Identifier | Ethicon,Inc |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ETHIZIA | Device | ETHIZIA patch will be applied to bleeding site intraoperatively. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperative (up to 10 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Pre-operative
Intra-operative
Exclusion Criteria:
Pre-operative
Intra-operative
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Schleckser | Contact | +1 908 808 6670 | pschleck@its.jnj.com | |
| Dr Richard Kocharian | Contact | +16096423787 | rkochar1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Ethicon Inc. Clinical Trial | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Hospital of USC | Recruiting | Los Angeles | California | 90033 | United States | |
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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| SURGICEL Original |
| Device |
SURGICEL Original will be applied to bleeding site intraoperatively. |
|
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). |
| 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. | Intraoperative (up to 10 minutes) |
| Median Time to Hemostasis at Target Bleeding Site | Median time to hemostasis at target bleeding site will be reported. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Intraoperative |
| Washington University Barnes Jewish Hospital |
| Recruiting |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Capital Health Medical Center - Hopewell | Recruiting | Pennington | New Jersey | 08534 | United States |
| New York Presbyterian - Weill Cornell Medical Ctr | Recruiting | New York | New York | 10065 | United States |
| UT Health East Texas EMS Air 1 | Recruiting | Tyler | Texas | 75701 | United States |
| Intermountain Medical Center | Recruiting | Murray | Utah | 84107 | United States |
| UMC Radboud | Recruiting | Nijmegen | 6500HB | Netherlands |