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

A Prospective, Randomized, Controlled Evaluation of Fibrin Sealant 2 (FS2) as an Adjunct to Hemostasis for Soft Tissue Bleeding During Retroperitoneal or Intra-Abdominal Surgery

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.

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®.

Inclusion Criteria:

• 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 Criteria:

• 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