Rapid Sternal Closure System (TALON)
Condition: Sternal Wound Infection; Mediastinitis
MeSH terms: Wound Infection; Mediastinitis
Intervention: Rapid Sternal Closure System; Conventional wire closure
Intervention description: Sternal talons will be used and supplemented with wires; Conventional wire closure of sternum
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sternal wound closure; cardiac surgery; sternal nonunion

Summary:

      The primary objective is to establish if the Rapid Sternal Closure System (RSCS) improves
      early postoperative recovery as manifested by decreased pain and improved pulmonary function.

      Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs
      (surgical wound complication defined as surgically treated sternal wound infection and
      sternal instability/non-union) as outlined in the protocol.

      For a given study endpoint, the null hypothesis will be no difference between the Rapid
      Sternal Closure System group and the control group. The alternative hypothesis will be a
      difference between 2 groups. The statistical objective of this study is to reject the null
      hypothesis in favor of the alternative hypothesis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female. Women of childbearing potential must have a negative serum (or urine)
             human chorionic gonadotropin assay prior to surgery, and be willing to continue to use
             effective means of birth control for at least 180 days following surgery. Medically
             acceptable contraceptives include: (1) surgical sterilization (such as a tubal
             ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control
             pills, patches, implants or injections), (3) barrier methods (such as a condom or
             diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive
             measures such as Plan B(TM), sold for emergency use after unprotected sex, are not
             acceptable methods for routine use.

          2. Age ≥ 18 years.

          3. Scheduled to undergo nonemergent on or off pump coronary artery bypass graft (CABG)
             and/or valve repair or replacement surgery through a full median sternotomy.

          4. At higher risk for SWC, defined as the presence of any of the following factors:
             obesity (body mass index > 30), chronic steroid use (>6 month duration and currently
             using), severe chronic obstructive pulomonary disease, planned bilateral internal
             mammary artery harvest, undergoing redo median sternotomy, and history of radiation to
             the chest.

          5. Willing and able to provide written informed consent.

          6. Available for evaluation from baseline until final evaluation at 180 days postsurgery.

        Exclusion Criteria:

          1. Undergoing emergency cardiac surgery (urgent surgery is allowed if informed consent is
             obtained and the study procedures can be performed).

          2. Undergoing a significant concomitant surgical procedure (eg, carotid endarterectomy,
             aortic root repair or replacement, deep hypothermic circulatory arrest [DHCA], or
             pulmonary resection).

          3. Undergoing a minimally invasive or a thoracic surgical approach.

          4. Using a preoperative mechanical assist device or intraaortic balloon pump (IABP), if
             inserted for shock/low output syndrome (an IABP is allowed if it is inserted for
             unstable angina or low ejection fraction).

          5. Active and significant systemic infection, eg, active endocarditis or a history of
             significant recurrent systemic infection.

          6. Receiving antibiotic therapy within the 2 weeks before the date of surgery.

          7. 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).

          8. History of major organ transplantation, including bone marrow transplantation.

          9. Recent history of significant drug or alcohol abuse.

         10. Current immunosuppressive condition (eg, symptomatic human immunodeficiency virus
             [HIV] infection). Use of steroids is not an exclusion criteria).

         11. Female subject who is pregnant (including a positive pregnancy test at screening or
             baseline) or nursing. Females of childbearing potential not practicing a birth control
             method with a high degree of reliability.

         12. Postsurgical life expectancy ≤ 90 days, in the investigator's or sponsor's opinion.

         13. Current participation or participation within 30 days before the start of this study
             in an experimental drug or device study or currently participating in a study during
             which the administration of investigational drugs within 90 days is anticipated.

         14. Refusal to accept medically indicated blood products.

         15. Moderate or severe pectus deformity.