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COMPLETEDPhase 2NCT00658723

The Fibrin Patch Soft Tissue Study

The effectiveness objective of this study is to evaluate whether Fibrin Patch is superior to SURGICEL™ as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding i...

Lead sponsor: Ethicon, Inc.•11 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Ethicon, Inc.

Collaborators

OMRIX Biopharmaceuticals

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subjects \>= 18 years of age, requiring non-emergent, open, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures
•Presence of an appropriate soft tissue Target Bleeding Site (TBS) as identified intraoperatively by the surgeon
•Subjects must be willing to participate in the study, and provide written informed consent

Exclusion Criteria

•Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
•Subject with TBS within an actively infected field
•Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine
•Subjects with known intolerance to blood products or to one of the components of the study product
•Subjects unwilling to receive blood products
•Subjects with immunodeficiency diseases (including known HIV)
•Subjects who are known, current alcohol and / or drug abusers
•Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
•Female subjects who are pregnant or nursing

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: September 11, 2014Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment141

Start dateMar 2008

Last updatedSep 11, 2014

Condition

Locations shown

University of Alabama

Birmingham, Alabama

Jacksonville Center for Clinical Research

Jacksonville, Florida

Baptist Hosptial

Miami, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 11, 2014Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions