A Study of ETHIZIA Versus SURGICEL Original in Controlling Soft Tissue Bleeding During Open Surgery

Ethicon

Status: Not yet enrolling

Conditions: Hemostasis; Hemostatic Techniques

Treatments: Device: ETHIZIA; Device: SURGICEL Original

Study type: Interventional

Funder types: Industry

Identifiers

NCT06664788

BIO202401

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

ETHIZIA

Experimental group

Description:

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.

Treatment:

Device: ETHIZIA

SURGICEL Original

Active Comparator group

Description:

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.

Treatment:

Device: SURGICEL Original