The Fibrin Patch Soft Tissue Study

A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

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 in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

Inclusion Criteria:

• 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 Criteria:

• 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