Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

Inclusion Criteria

• •Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (not including minimally invasive procedures; arterial reconstruction; peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access procedures
• •History of surgery with high likelihood of exposure to bovine thrombin within the past 3 years. Prior surgery must have been 1 of the following open procedures: open procedures involving the spine or cranium, PAB grafting, AV vascular access procedures, autologous skin grafting, or other surgical procedure accompanied by documented treatment with bovine thrombin
• •Age of 18 years or younger at time of informed consent
• •If female and of child-bearing potential: Negative pregnancy test result within 14 days prior to treatment
• •Use of a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if sexually active male or a sexually active female of childbearing potential
• •Signed IRB/independent ethics committee-approved informed consent document