Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Inclusion Criteria: * Scheduled to undergo nonemergent CABG and/or valve repair or replacement surgery through a full median sternotomy. This includes the following eligible procedures: isolated CABG surgery, isolated valve surgery, and combined CABG + valve surgery. * Be at higher risk for SWI, defined as the presence of diabetes mellitus (treated with either oral agent or insulin) and/or obesity, defined as BMI \> 30. * Have the capacity to understand and sign an informed consent form. * Are male or female and \> 18 years of age. * If female, be postmenopausal (no menstrual period for a minimum of 1 year), be surgically sterilized and have a negative serum or urine pregnancy test on entry in the study, or agree to use adequate birth control during the study and for 3 months after the administration of study agent. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). * Agree to be available for evaluation from baseline until final evaluation at 90 days postsurgery. Exclusion Criteria: * Known history of hypersensitivity to gentamicin or bovine collagen. * Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is obtained and the study procedures can be performed). * Undergoing a significant concomitant surgical procedure (eg, carotid endartere…