Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery
NCT ID: NCT00307515
Last Updated: 2009-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
135 participants
INTERVENTIONAL
2006-02-28
2006-12-31
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 Sealant 2 (FS2)
Fibrin Sealant 2 (FS2)
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
2
Oxidized Regenerated Cellulose (Surgicel)
Oxidized Regenerated Cellulose (Surgicel)
Commercially available Surgicel used within label.
Interventions
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Fibrin Sealant 2 (FS2)
FS2 Surgical Sealant Kit: Biological Active Component containing Human Fibrinogen 55-85 mg/mL and Thrombin containing Thrombin 800-1200 IU/mL and Calcium Chloride 5.6-6.2 mg/mL
Oxidized Regenerated Cellulose (Surgicel)
Commercially available Surgicel used within label.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
ALL
No
Sponsors
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OMRIX Biopharmaceuticals
INDUSTRY
Ethicon, Inc.
INDUSTRY
Responsible Party
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Ethicon
Principal Investigators
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James Hart, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Children's Hospital of Los Angeles
Los Angeles, California, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Miami Research Associates
Miami, Florida, United States
Medical College of Georgia
Augusta, Georgia, United States
The Iowa Clinic
Des Moines, Iowa, United States
St. Agnes Healthcare, Inc.
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Cooper University Hospital
Camden, New Jersey, United States
Mt. Sinai Hospital
New York, New York, United States
GYN Oncology Associates
Syracuse, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Lankenau Hospital
Wynnewood, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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400-05-006
Identifier Type: -
Identifier Source: org_study_id
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