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

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innocoll
• Collaborators: Duke University; Premier Research Group plc
• Treatments: Gentamicins

Criteria

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 endarterectomy, aortic root repair or replacement, DHCA, or pulmonary resection).

• Undergoing a minimally invasive or a thoracic surgical approach.

• Using a preoperative mechanical assist device or IABP if inserted for shock/low output syndrome (an IABP is allowed if it is inserted for unstable angina).

• Active and significant systemic infection, eg active endocarditis, or a history of significant recurrent systemic infection.

• Receiving antibiotic therapy within the 2 weeks before the date of surgery.

• Preoperative serum creatinine > 3 mg/dL or renal failure requiring dialysis.

• History of malignancy within the past year (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).

• History of major organ transplantation, including bone marrow transplantation.

• Recent history of significant drug or alcohol abuse.

• Taking systemic immunosuppressive drugs, including steroids (at a dose > 10 mg oral prednisone daily) or a history of a current immunosuppressive condition (eg, symptomatic HIV infection), defined as a CD4 count < 200.

• Scheduled to receive "stress doses" of glucocorticoids (ie, doses > 2 mg/kg/day of methylprednisolone or equivalent).

• Pregnant, lactating, or of childbearing potential not practicing a birth control method with a high degree of reliability (defined in section 3.1).

• Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.

• Refusal to accept medically indicated blood products.

• Current participation or participation within 30 days before the start of this study in another experimental drug or device study, or is currently participating in a study during which the administration of investigational drugs within 90 days is anticipated.

• Has a moderate or severe pectus deformity.