[Prueba de un dispositivo que no está aprobado ni autorizado por la FDA de EE. UU.]
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- Keck Hospital of USC
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University Barnes Jewish Hospital
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New Jersey
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Pennington, New Jersey, Estados Unidos, 08534
- Capital Health Medical Center - Hopewell
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New York
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New York, New York, Estados Unidos, 10065
- New York Presbyterian - Weill Cornell Medical Ctr
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Texas
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Tyler, Texas, Estados Unidos, 75701
- UT Health East Texas EMS Air 1
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Utah
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Murray, Utah, Estados Unidos, 84107
- Intermountain Medical Center
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Nijmegen, Países Bajos, 6500HB
- UMC Radboud
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ETHIZIA
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. |
ETHIZIA patch will be applied to bleeding site intraoperatively. |
|
Comparador activo: SURGICEL Original
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. |
SURGICEL Original will be applied to bleeding site intraoperatively. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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. |
Intraoperative (up to 10 minutes)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Hemostasis at Target Bleeding Site
Periodo de tiempo: 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. |
Intraoperative (up to 10 minutes)
|
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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
Periodo de tiempo: Intraoperative (up to 10 minutes)
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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)
|
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Time to Hemostasis for All Treated Bleeding Sites
Periodo de tiempo: Intraoperative (up to 10 minutes)
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Time to achieve hemostasis for all treated bleeding sites for up to 10 minutes will be evaluated. |
Intraoperative (up to 10 minutes)
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Median Time to Hemostasis at Target Bleeding Site
Periodo de tiempo: Intraoperative
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Median time to hemostasis at target bleeding site will be reported. |
Intraoperative
|
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Median Time to Hemostasis for All Treated Bleeding Sites
Periodo de tiempo: Intraoperative
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Median time to hemostasis for all treated bleeding sites will be reported for both groups. |
Intraoperative
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Treatment Failure for Target Bleeding Site Treated and for All Treated Bleeding Sites
Periodo de tiempo: Intraoperative (up to 10 minutes)
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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)
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Sustained Hemostasis at All Treated Bleeding Sites
Periodo de tiempo: Intraoperative
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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
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Proportion of Bleeding Sites with Rebleeding After 10 Minutes
Periodo de tiempo: Intraoperative
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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
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Percentage of Bleeding Sites Achieving Hemostasis with ETHIZIA or SURGICEL Original
Periodo de tiempo: At 30, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 seconds
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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
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Proportion of Bleeding Sites Requiring More Than One Application of ETHIZIA or SURGICEL Original to Achieve Hemostasis
Periodo de tiempo: Intraoperative
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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
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Proportion of Bleeding Sites that Require a Second Surgical Maneuver to Achieve Hemostasis
Periodo de tiempo: Intraoperative
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ethicon Inc. Clinical Trial, Ethicon, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- BIO202401
- BIO202401 (Otro identificador: Ethicon,Inc)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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