Evaluation of Fibrin Sealant 2 in Retroperitoneal or Intra-Abdominal Surgery

Completed · Phase 3

Conditions studied: Blood Loss, Surgical

In brief

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.

Key facts

Study ID

NCT00307515

Run by

Ethicon, Inc.

People needed

135

Starts

2006-02-01

Expected to finish

2006-12-01

Last updated by the study team

2009-01-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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