Status:
COMPLETED
Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
Lead Sponsor:
Ethicon, Inc.
Collaborating Sponsors:
OMRIX Biopharmaceuticals
Conditions:
Blood Loss, Surgical
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
A comparison of fibrin sealant 2 versus Surgicel® as an addition to standard surgical practice in stopping mild to moderate soft tissue bleeding during retroperitoneal or intra-abdominal surgery.
Detailed Description
The time it will take to stop bleeding will be measured and compared between patients who are treated with fibrin sealant 2 to those who are treated with Surgicel®.
Eligibility Criteria
Inclusion
- Male and Female subjects requiring non-emergent retroperitoneal or intra-abdominal surgical procedures
- Presence of an appropriate soft-tissue target bleeding site (challenging bleeding site for which topical hemostatic adjuncts might typically be used) as identified intra-operatively by the surgeon
- Subjects must be willing to participate in the study and provide written informed consent
Exclusion
- Subjects undergoing emergency surgery
- Parenchymal or anastomotic bleeding sites will not be considered for randomization
- Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
- Subjects with known intolerance to blood products or to one for the components of the study product
- Subjects unwilling to receive blood products
- Subjects with known autoimmune 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 :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00307515
Start Date
February 1 2006
End Date
December 1 2006
Last Update
January 9 2009
Active Locations (16)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
Miami Research Associates
Miami, Florida, United States, 33173
4
Medical College of Georgia
Augusta, Georgia, United States, 30912