Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
Condition: Cardiac Surgery; Sternal Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Wounds and Injuries
Intervention: gentamicin-collagen sponge dipped in saline
Intervention description: 100-cm2 sponge
Intervention MeSH terms: Gentamicins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: obesity; diabetes

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.
    

Eligibility 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.