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

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