Study of the Combination of a Cyanoacrylate and Surgical Solutions in Reducing Skin Flora Contamination
Condition: Skin Flora Contamination
Intervention: InteguSeal* skin sealant and standard surgical preparation; Standard preoperative skin preparation
Intervention description: Surgical skin preparation prior to incision using InteguSeal* skin sealant following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.; Surgical skin preparation prior to incision using standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 293.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cyanoacrylates; microbial sealants; skin flora contamination; surgery

Summary:

      The purpose of this study is to determine if there is a qualitative reduction in microbial
      skin flora post-surgery compared to pre-surgery when a cyanoacrylate based microbial sealant
      is used in combination with a surgical skin preparation solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for an elective Coronary Artery Bypass Graft (CABG) surgical procedure with
             median sternotomy utilizing either the saphenous vein and/or radial artery as one of
             the graft sites within 28 days of the screening date, as documented by a
             Cardiothoracic Surgeon who is the Principal Investigator or sub-investigator. This
             includes subjects who are also receiving internal mammary artery grafts in addition to
             saphenous vein and/or radial artery grafts.

          -  The skin near or around the proposed incision sites should be intact.

        Exclusion Criteria:

          -  Known sensitivity or allergy to cyanoacrylate, isopropyl alcohol, iodine or
             iodine-containing products or tape allergies.

          -  Female subjects that are nursing or actively lactating.

          -  Abnormal skin condition adjacent to or at the surgical incision sites.

          -  Hair removal at the surgical sites prior to entrance to the operating suite.

          -  Use of antimicrobial impregnated incise drapes (i.e. Ioban®).

          -  Hospital stay of >14 days immediately prior to scheduled CABG surgery.

          -  Use of chemotherapy agents, within 30 days prior to Visit 1 screening.

          -  Scheduled for additional chemotherapy for the duration of the study.

          -  Known positive Human Immunodeficiency Virus (HIV) with a CD4 count < 350 mm3. If HIV
             status is not known, the subject is not excluded.

          -  Currently taking antibiotics for an infection (within 30 days prior to Visit 1).

          -  Has had therapeutic radiation to the chest within 30 days of visit 1. This does not
             include subjects who receive chest xrays.

          -  Pre-operatively scheduled to have concomitant procedures with coronary artery bypass
             graft procedure.

          -  Scheduled to receive only one incision (a median sternotomy) without a planned
             saphenous vein graft and/or a radial artery graft donor site.

          -  Renal dialysis currently or within 30 days of visit 1.

          -  Morbid Obesity (Subjects with a Body Mass Index (BMI) > 37).

          -  Neutropenia (absolute neutrophil count <1000/mm3).

          -  Pre-operatively on an intra-aortic balloon pump or mechanical assist device.

          -  Has received an experimental drug or used an experimental medical device within 30
             days prior to Visit 1.

          -  Employees of the investigator or study center with direct involvement in the proposed
             study or other studies under the direction of that investigator or study center.

          -  Any condition, which in the opinion of the investigator would exclude the subject from
             the study.

          -  Patients on steroid use for more than 1 week within 30 days of visit 1.

          -  Patients on immunosuppressive therapy within 30 days of visit 1.

          -  Depilatory creams with containing antibiotics.