Hemostasis, Hemostatic Techniques
Conditions
Brief 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 re-bleeding up to 10 minutes after application.
Interventions
DEVICEETHIZIA
ETHIZIA patch will be applied to bleeding site intraoperatively.
DEVICESURGICEL Original
SURGICEL Original will be applied to bleeding site intraoperatively.
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis at Target Bleeding Site | Intraoperative (up to 10 minutes) | Time to achieve hemostasis for target bleeding site up to 10 minutes will be evaluated and presented using Kaplan-Meier estimated distribution. |
| 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 | Intraoperative (up to 10 minutes) | 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 to Hemostasis for All Treated Bleeding Sites | Intraoperative (up to 10 minutes) | Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated. |
| Median Time to Hemostasis at Target Bleeding Site | Intraoperative | Median time to hemostasis at target bleeding site will be reported. |
| Median Time to Hemostasis for All Treated Bleeding Sites | Intraoperative | Median time to hemostasis for all treated bleeding sites will be reported for both groups. |
| Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites | Intraoperative (up to 10 minutes) | 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. |
| Sustained Hemostasis at All Treated Bleeding Sites | Intraoperative | 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. |
| Proportion of Bleeding Sites with Rebleeding After 10 Minutes | Intraoperative | 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. |
| Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original | At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds | 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. |
| Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis | Intraoperative | 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. |
| Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis | Intraoperative | 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. |
Countries
Netherlands, United States
Contacts
CONTACTPatricia Schleckser
CONTACTDr Richard Kocharian
STUDY_DIRECTOREthicon Inc. Clinical Trial
Ethicon, Inc.
Outcome results
None listed