Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.

Major Inclusion Criteria:

• Scheduled for non-emergent, hepatic surgery
• Presence of an appropriate target bleeding site (TBS) as defined by the protocol

Major Exclusion Criteria:

• Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
• In subjects with documented history of cirrhosis, subject has uncorrected platelet count <60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
• Subject has severe coagulopathy defined as INR > 2.0
• Subject has Total Bilirubin >2.5mg/dL
• Subject has an active local infection at the Target Bleeding Site
• Study procedure involves a liver transplant recipient