The Fibrin Patch Soft Tissue Study

Completed · Phase 2

Conditions studied: Hemostasis

In brief

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 in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Key facts

Study ID

NCT00658723

Run by

Ethicon, Inc.

People needed

141

Starts

2008-03-01

Expected to finish

2009-05-01

Last updated by the study team

2014-09-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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