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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ethicon, Inc.
Study ID
NCT06664788
Status
Recruiting
Apply to this trial

Conditions

  • Hemostasis
  • Hemostatic Techniques

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ETHIZIA — DEVICE
    ETHIZIA patch will be applied to bleeding site intraoperatively.
  • SURGICEL Original — DEVICE
    SURGICEL Original will be applied to bleeding site intraoperatively.

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

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 [ Time Frame: Intraoperative (up to 10 minutes) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Keck Hospital of USCLos AngelesCalifornia90033-
Washington University Barnes Jewish HospitalSt LouisMissouri63110-
Capital Health Medical Center - HopewellPenningtonNew Jersey08534-
New York Presbyterian - Weill Cornell Medical CtrNew YorkNew York10065-
UT Health East Texas EMS Air 1TylerTexas75701-
Intermountain Medical CenterMurrayUtah84107-

Find similar trials in Los Angeles, CA

By research site
Keck Hospital of USC· Los Angeles, CAWashington University Barnes Jewish Hospital· St Louis, MOCapital Health Medical Center - Hopewell· Pennington, NJNew York Presbyterian - Weill Cornell Medical Ctr· New York, NYUT Health East Texas EMS Air 1· Tyler, TXIntermountain Medical Center· Murray, UT

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