Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2008-03-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Fibrin Pad
Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
2
SURGICEL™ Absorbable Hemostat
SURGICEL™
Absorbable hemostat
Interventions
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Fibrin Pad
Fibrin Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
SURGICEL™
Absorbable hemostat
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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James Hart, M.D.
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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University of Alabama
Birmingham, Alabama, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Baptist Hosptial
Miami, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
St. Agnes Healthcare, Inc.
Baltimore, Maryland, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Weill Medical Colleges of Cornell University - Methodist Hospital
Houston, Texas, United States
Countries
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References
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Fischer CP, Bochicchio G, Shen J, Patel B, Batiller J, Hart JC. A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery. J Am Coll Surg. 2013 Sep;217(3):385-93. doi: 10.1016/j.jamcollsurg.2013.02.036.
Corral M, Ferko N, Hollmann S, Hogan A, Jamous N, Batiller J, Shen J. Clinician reported ease of use for a novel fibrin sealant patch for hemostasis: results from four randomized controlled trials. Curr Med Res Opin. 2016;32(2):367-75. doi: 10.1185/03007995.2015.1128405. Epub 2015 Dec 21.
Other Identifiers
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400-07-002
Identifier Type: -
Identifier Source: org_study_id
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