Present trial is one of two trials (the other being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support a general hemostasis indication across several surgical procedures and organ systems in the USA. The patient will come for a screening and baseline visit, the day of surgery and follow up visits after 1 months, 3 months and 6 months. The enrollment period is planned for 16 months and 6 months of follow up.
Patients undergoing prosthetic lower extremity bypass
Patients who experience bleeding at the most proximal graft site will be treated with either the Study Drug, TachoSil, or a commercially available fibrin sealant, Surgicel Original to treat the bleeding.
Patients will be in the study for six months.
Tiffany Whitaker, RN (217) 545-2531 email@example.com
Kim Hodgson, MD