Rapid Sternal Closure System (TALON)

Mediastinitis Clinical Trial

— TALON  

Official title:

A Randomized, Controlled, Phase 4 Study of Sternal Plating (Rapid Sternal Closure System, KLS Martin L.P.) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Complications.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638014
• Other study ID #: PRO00006260
• Status: Completed
• Phase: Phase 4
• First received: March 12, 2008
• Last updated: April 5, 2011
• Start date: March 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Mediastinitis
• Sternal Wound Infection
• Wound Infection

Intervention

Device:
• Rapid Sternal Closure System
Sternal talons will be used and supplemented with wires
• Conventional wire closure
Conventional wire closure of sternum

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	KLS Martin, L.P.

Country where clinical trial is conducted

United States, 

References & Publications (31)

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Bratzler DW, Houck PM; Surgical Infection Prevention Guidelines Writers Workgroup; American Academy of Orthopaedic Surgeons; American Association of Critical Care Nurses; American Association of Nurse Anesthetists; American College of Surgeons; American College of Osteopathic Surgeons; American Geriatrics Society; American Society of Anesthesiologists; American Society of Colon and Rectal Surgeons; American Society of Health-System Pharmacists; American Society of PeriAnesthesia Nurses; Ascension Health; Association of periOperative Registered Nurses; Association for Professionals in Infection Control and Epidemiology; Infectious Diseases Society of America; Medical Letter; Premier; Society for Healthcare Epidemiology of America; Society of Thoracic Surgeons; Surgical Infection Society. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis. 2004 Jun 15;38(12):1706-15. Epub 2004 May 26. Review. — View Citation

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Dhadwal K, Al-Ruzzeh S, Athanasiou T, Choudhury M, Tekkis P, Vuddamalay P, Lyster H, Amrani M, George S. Comparison of clinical and economic outcomes of two antibiotic prophylaxis regimens for sternal wound infection in high-risk patients following coronary artery bypass grafting surgery: a prospective randomised double-blind controlled trial. Heart. 2007 Sep;93(9):1126-33. Epub 2007 Feb 19. — View Citation

Dickie SR, Dorafshar AH, Song DH. Definitive closure of the infected median sternotomy wound: a treatment algorithm utilizing vacuum-assisted closure followed by rigid plate fixation. Ann Plast Surg. 2006 Jun;56(6):680-5. — View Citation

Dodds Ashley ES, Carroll DN, Engemann JJ, Harris AD, Fowler VG Jr, Sexton DJ, Kaye KS. Risk factors for postoperative mediastinitis due to methicillin-resistant Staphylococcus aureus. Clin Infect Dis. 2004 Jun 1;38(11):1555-60. Epub 2004 May 12. — View Citation

Edwards FH, Engelman RM, Houck P, Shahian DM, Bridges CR; Society of Thoracic Surgeons. The Society of Thoracic Surgeons Practice Guideline Series: Antibiotic Prophylaxis in Cardiac Surgery, Part I: Duration. Ann Thorac Surg. 2006 Jan;81(1):397-404. — View Citation

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Finkelstein R, Rabino G, Mashiah T, Bar-El Y, Adler Z, Kertzman V, Cohen O, Milo S. Vancomycin versus cefazolin prophylaxis for cardiac surgery in the setting of a high prevalence of methicillin-resistant staphylococcal infections. J Thorac Cardiovasc Surg. 2002 Feb;123(2):326-32. — View Citation

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Hendrickson SC, Koger KE, Morea CJ, Aponte RL, Smith PK, Levin LS. Sternal plating for the treatment of sternal nonunion. Ann Thorac Surg. 1996 Aug;62(2):512-8. — View Citation

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Lu JC, Grayson AD, Jha P, Srinivasan AK, Fabri BM. Risk factors for sternal wound infection and mid-term survival following coronary artery bypass surgery. Eur J Cardiothorac Surg. 2003 Jun;23(6):943-9. — View Citation

Olsen MA, Lock-Buckley P, Hopkins D, Polish LB, Sundt TM, Fraser VJ. The risk factors for deep and superficial chest surgical-site infections after coronary artery bypass graft surgery are different. J Thorac Cardiovasc Surg. 2002 Jul;124(1):136-45. — View Citation

Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8. — View Citation

Ridderstolpe L, Gill H, Granfeldt H, Ahlfeldt H, Rutberg H. Superficial and deep sternal wound complications: incidence, risk factors and mortality. Eur J Cardiothorac Surg. 2001 Dec;20(6):1168-75. — View Citation

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Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. — View Citation

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline, Maximum value during postoperatively days 1 thru 7	No
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.	Up to 180 days	Yes