The primary objective is to establish if the Rapid Sternal Closure System 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
(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 RSCS 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
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 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 COPD (FEV1 <50% predicted), planned bilateral IMA 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
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
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), defined as a CD4
count < 200 cells/mL3 of blood (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