Mediastinitis, Sternal Wound Infection
Conditions
Keywords
Sternal wound closure, cardiac surgery, sternal nonunion
Brief 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.
Interventions
DEVICERapid Sternal Closure System
Sternal talons will be used and supplemented with wires
DEVICEConventional wire closure
Conventional wire closure of sternum
Sponsors
KLS Martin, L.P.
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved | Baseline, Maximum value during postoperatively days 1 thru 7 | Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union | Up to 180 days | The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications. |
Countries
United States
Participant flow
Recruitment details
Subjects were consented and enrolled in the study at 2 centers from April 2008 to July 2009.
Pre-assignment details
Overall 53 subjects were consented and enrolled in the study from April 2008 to July 2009. Two patients were not included in the analysis (1 patients' surgery was cancelled, 1 patient was not randomized due to logistical reasons), leaving a total of 51 subjects who were included in the modified intent-to-treat analysis.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Wires Only The control group received conventional wires including double wires to close the sternum. | 23 |
| Talon Subjects randomized to the Talon group received Talons in the sternum plus supplementary wires in the manubrium. The number of Talons inserted was based on patient factors/clinician judgment. For study subjects randomized to the Talon, the device was to be inserted/used in an identical manner to use of the Talon in non-study patients. | 28 |
| Total | 51 |
Baseline characteristics
| Characteristic | Talon | Conventional Wires Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 9 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Age Continuous | 61.8 years STANDARD_DEVIATION 10 | 63.0 years STANDARD_DEVIATION 9.2 | 62.4 years STANDARD_DEVIATION 9.6 |
| Region of Enrollment United States | 28 participants | 23 participants | 51 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 24 Participants | 14 Participants | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 28 |
| serious Total, serious adverse events | 1 / 23 | 1 / 28 |
Outcome results
Primary
Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved
Maximum incentive spirometry volume was measured at baseline (prior to surgery) and daily from postoperative day 1 through postoperative day 7 (or discharge if earlier) using a Coach 2 incentive spirometer with one way valve (Coach 2 model # 22-4000, Smiths Medical, Keene, NH).
Time frame: Baseline, Maximum value during postoperatively days 1 thru 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Conventional Wires Only | Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved | 58 percentage change | Standard Deviation 24 |
| Talon | Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved | 67 percentage change | Standard Deviation 32 |
p-value: 0.41t-test, 2 sided
Secondary
Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union
The Data and Safety Monitoring Board reviewed source documents for all cases with possible sternal wound infection and sternal instability or non-union and made a determination as to the presence of these complications.
Time frame: Up to 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional Wires Only | Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union | 1 Participants |
| Talon | Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union | 1 Participants |