To achieve hemostasis (to stop a bleeding) during open surgery To stop bleeding during surgery
Conditions
Interventions
Ethizia patch
Sponsors
Ethicon, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is scheduled to undergo an elective open, abdominal, retroperitoneal, pelvic, thoracic (non-cardiac) or extremity surgical procedure; 2. Subject has been informed of the nature of the clinical investigation; 3. Subject is willing and able to give written informed consent for the clinical investigation participation; 4. Subject is 22 years of age or older at the time of enrollment. 5. Subject in whom the Investigator is able to 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; 6. 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; and 7. Subject has a Target Bleeding Site with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3 (e.g., reflecting minimal, mild, or moderate bleeding severities).
Exclusion criteria
Exclusion criteria: Subject is scheduled for another planned surgery within the follow-up period and the subsequent surgery would jeopardize the ETHIZIA or SURGICEL® Original application (e.g., ETHIZIA or SURGICEL® Original application to biopsy site that may require further surgery); 2. Subject has platelet count 100s, or international normalized ratio >2.5; 3. Subject is taking multiple antithrombotic therapies in therapeutic dosage up to the time of surgery, but allowing exclusive use of acetylsalicylic acid; 4. Subject is pregnant, planning on becoming pregnant, or actively breastfeeding during the 28-day follow-up period; 5. Subject has a known hypersensitivity to brilliant blue (FD&C Blue #1) or porcine gelatin; 6. Subject who has religious objections to receiving products with porcine gelatin; 7. Subject has an active or suspected infection at the bleeding site; 8. Subject in whom the medical device will be used at the site of a synthetic graft, mesh, anti-adhesive membranes, or patch implant; 9. Subject has a life expectancy of less than 3 months; 10. Subject has a documented severe congenital or acquired immunodeficiency; 11. Subject is currently participating or has participated in another clinical investigation within the past 30 days of planned surgery that may affect the endpoints of the study, such as trials related to the surgical procedure, and anti-coagulation; 12. Subject is not appropriate for inclusion in the clinical investigation, per the medical opinion of the Investigator; or 13. Subject has any incidental (pre- and peri-operative) findings deemed by the Investigator to potentially jeopardize the safety or welfare of the subject. 14. The 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; 15. The target bleeding site is from a large defect in an artery or vein that requires vascular reconstruction with maintenance of vessel patency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage of cases achieving hemostasis at 3 minutes following product application and with no rebleeding at 10 minutes following application at the Target Bleeding Site. Hemostasis is defined by a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale (SBSS) and is considered as achieving hemostasis on the direct surface onto which ETHIZIA or SURGICEL® Original is applied. Additional pressure alone or with additional randomized product may be applied if hemostasis is not achieved at 30 seconds and up to 3 minutes without it affecting the primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints for this clinical investigation are defined as: 1. Kaplan-Meier estimated distribution of time to hemostasis up to 10 minutes at the Target Bleeding Site; 2. Percentage of bleeding sites achieving hemostasis at 3 minutes after product application, and without rebleeding up to 10 minutes after application for all treated bleeding sites. 3. Time to hemostasis up to 10 minutes for all treated bleeding sites; Other Secondary Endpoints: 4. Median time to hemostasis of the Target Bleeding Site (descriptively analyzed); 5. Median time to hemostasis for all treated bleeding sites (descriptively analyzed); 6. Treatment failure, defined as no hemostasis at 10 minutes or received rescue therapy prior to 10 minutes from the application of the study product. Summaries will be presented for Target Bleeding Site and for all treated bleeding sites;7. Sustained hemostasis at all treated bleeding sites, defined as achieving hemostasis at 3 minutes with no rebleeding up to Day 28 (-5 days to +14 days). Summaries will be descriptive for all treated bleeding sites. 8. Proportion of bleeding sites with rebleeding after 10 minutes and prior to initiation of final fascia closure. Summaries will be presented for Target Bleeding Site and for all treated bleeding sites; 9. Percentage of bleeding sites achieving hemostasis with study product at the timepoints: 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds. Summaries will be presented for Target Bleeding Site and for all treated bleeding sites; 10. Proportion of bleeding sites that require more than one application of the randomized treatment (ETHIZIA or SURGICEL Original) to achieve hemostasis. Summaries will be presented for Target Bleeding Site and for all treated bleeding sites; and 11. Proportion of bleeding sites that require a second surgical maneuver (e.g. adjunct product, electrocautery, etc.) as a rescue therapy to achieve hemostasis f | — |
Countries
Netherlands, United States
Contacts
Public ContactR Kocharian
Ethicon, Inc.
Outcome results
None listed