Status:
COMPLETED
The Fibrin Patch Soft Tissue Study
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Hemostasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00658723
Start Date
March 1 2008
End Date
May 1 2009
Last Update
September 11 2014
Active Locations (11)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
Baptist Hosptial
Miami, Florida, United States, 33173
4
Emory University Hospital
Atlanta, Georgia, United States, 30322