Rapid Sternal Closure System (TALON) (TALON)

• ClinicalTrials.gov Identifier: NCT00638014
• Recruitment Status: Completed
• First Posted: March 18, 2008
• Results First Posted: May 2, 2011
• Last Update Posted: May 2, 2011
• Sponsor: Duke University
• Collaborator: KLS Martin, L.P.
• Information provided by: Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sternal Wound Infection; Mediastinitis	Device: Rapid Sternal Closure System; Device: Conventional wire closure	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• 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.
• Study Start Date: March 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Conventional wires only	Device: Conventional wire closure; Conventional wire closure of sternum
Experimental: 2; Rapid Sternal Closure System supplemented with wires	Device: Rapid Sternal Closure System; Sternal talons will be used and supplemented with wires

Outcome Measures

Primary Outcome Measures :

1. Percentage Change of Preoperative Incentive Spirometry (IS) Volume Achieved [ Time Frame: 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 Outcome Measures :

1. Number of Participants With Sternal Wound Infection or Sternal Instability/Non-union [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

KLS Martin, L.P.

Investigators

• Principal Investigator: Elliott Bennett-Guerrero, M. D.; Duke University

More Information

Publications:

Fry DE. The economic costs of surgical site infection. Surg Infect (Larchmt). 2002;3 Suppl 1:S37-43. doi: 10.1089/sur.2002.3.s1-37.

Friberg O, Dahlin LG, Levin LA, Magnusson A, Granfeldt H, Kallman J, Svedjeholm R. Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups. Scand Cardiovasc J. 2006 Apr;40(2):117-25. doi: 10.1080/14017430500363024.

Demmy TL, Park SB, Liebler GA, Burkholder JA, Maher TD, Benckart DH, Magovern GJ Jr, Magovern GJ Sr. Recent experience with major sternal wound complications. Ann Thorac Surg. 1990 Mar;49(3):458-62. doi: 10.1016/0003-4975(90)90256-6.

Tang GH, Maganti M, Weisel RD, Borger MA. Prevention and management of deep sternal wound infection. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):62-9. doi: 10.1053/j.semtcvs.2004.01.005.

Braxton JH, Marrin CA, McGrath PD, Morton JR, Norotsky M, Charlesworth DC, Lahey SJ, Clough R, Ross CS, Olmstead EM, O'Connor GT. 10-year follow-up of patients with and without mediastinitis. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):70-6. doi: 10.1053/j.semtcvs.2004.01.006.

Hollenbeak CS, Murphy DM, Koenig S, Woodward RS, Dunagan WC, Fraser VJ. The clinical and economic impact of deep chest surgical site infections following coronary artery bypass graft surgery. Chest. 2000 Aug;118(2):397-402. doi: 10.1378/chest.118.2.397.

Boyce JM, Potter-Bynoe G, Dziobek L. Hospital reimbursement patterns among patients with surgical wound infections following open heart surgery. Infect Control Hosp Epidemiol. 1990 Feb;11(2):89-93. doi: 10.1086/646127.

Baskett RJ, MacDougall CE, Ross DB. Is mediastinitis a preventable complication? A 10-year review. Ann Thorac Surg. 1999 Feb;67(2):462-5. doi: 10.1016/s0003-4975(98)01195-3.

Sakamoto H, Fukuda I, Oosaka M, Nakata H. Risk factors and treatment of deep sternal wound infection after cardiac operation. Ann Thorac Cardiovasc Surg. 2003 Aug;9(4):226-32.

Crabtree TD, Codd JE, Fraser VJ, Bailey MS, Olsen MA, Damiano RJ Jr. Multivariate analysis of risk factors for deep and superficial sternal infection after coronary artery bypass grafting at a tertiary care medical center. Semin Thorac Cardiovasc Surg. 2004 Spring;16(1):53-61. doi: 10.1053/j.semtcvs.2004.01.009.

Fowler VG Jr, O'Brien SM, Muhlbaier LH, Corey GR, Ferguson TB, Peterson ED. Clinical predictors of major infections after cardiac surgery. Circulation. 2005 Aug 30;112(9 Suppl):I358-65. doi: 10.1161/CIRCULATIONAHA.104.525790.

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. doi: 10.1067/mtc.2002.122306.

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. doi: 10.1016/s1010-7940(01)00991-5.

Trick WE, Scheckler WE, Tokars JI, Jones KC, Reppen ML, Smith EM, Jarvis WR. Modifiable risk factors associated with deep sternal site infection after coronary artery bypass grafting. J Thorac Cardiovasc Surg. 2000 Jan;119(1):108-14. doi: 10.1016/s0022-5223(00)70224-8.

Abboud CS, Wey SB, Baltar VT. Risk factors for mediastinitis after cardiac surgery. Ann Thorac Surg. 2004 Feb;77(2):676-83. doi: 10.1016/S0003-4975(03)01523-6.

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. doi: 10.1086/420819. Epub 2004 May 12.

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. doi: 10.1016/s1010-7940(03)00137-4.

Jonkers D, Elenbaas T, Terporten P, Nieman F, Stobberingh E. Prevalence of 90-days postoperative wound infections after cardiac surgery. Eur J Cardiothorac Surg. 2003 Jan;23(1):97-102. doi: 10.1016/s1010-7940(02)00662-0.

Eklund AM, Valtonen M, Werkkala KA. Prophylaxis of sternal wound infections with gentamicin-collagen implant: randomized controlled study in cardiac surgery. J Hosp Infect. 2005 Feb;59(2):108-12. doi: 10.1016/j.jhin.2004.10.005.

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. doi: 10.1067/mtc.2002.119698.

Friberg O, Svedjeholm R, Soderquist B, Granfeldt H, Vikerfors T, Kallman J. Local gentamicin reduces sternal wound infections after cardiac surgery: a randomized controlled trial. Ann Thorac Surg. 2005 Jan;79(1):153-61; discussion 161-2. doi: 10.1016/j.athoracsur.2004.06.043.

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. doi: 10.1097/01.sap.0000202825.41069.c3.

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.

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. doi: 10.1016/j.athoracsur.2005.03.089.

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. doi: 10.1016/j.ejcts.2004.04.038.

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. doi: 10.1016/j.athoracsur.2005.06.034. No abstract available.

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. doi: 10.1086/421095. Epub 2004 May 26.

Engelman R, Shahian D, Shemin R, Guy TS, Bratzler D, Edwards F, Jacobs M, Fernando H, Bridges C; Workforce on Evidence-Based Medicine, Society of Thoracic Surgeons. The Society of Thoracic Surgeons practice guideline series: Antibiotic prophylaxis in cardiac surgery, part II: Antibiotic choice. Ann Thorac Surg. 2007 Apr;83(4):1569-76. doi: 10.1016/j.athoracsur.2006.09.046. No abstract available.

Bolon MK, Morlote M, Weber SG, Koplan B, Carmeli Y, Wright SB. Glycopeptides are no more effective than beta-lactam agents for prevention of surgical site infection after cardiac surgery: a meta-analysis. Clin Infect Dis. 2004 May 15;38(10):1357-63. doi: 10.1086/383318. Epub 2004 Apr 21.

Harton SC, Grap MJ, Savage L, Elswick RK. Frequency and predictors of return to incentive spirometry volume baseline after cardiac surgery. Prog Cardiovasc Nurs. 2007 Winter;22(1):7-12. doi: 10.1111/j.0889-7204.2007.05199.x.

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. doi: 10.1136/hrt.2006.103002. Epub 2007 Feb 19.

• Responsible Party: Gary Moore/ Regulatory Affair, Quality Assurance, KLS Martin, L.P.
• ClinicalTrials.gov Identifier: NCT00638014
• Other Study ID Numbers: PRO00006260
• First Posted: March 18, 2008
• Results First Posted: May 2, 2011
• Last Update Posted: May 2, 2011
• Last Verified: April 2011

Keywords provided by Duke University:

Sternal wound closure; cardiac surgery; sternal nonunion

Additional relevant MeSH terms:

Wound Infection; Mediastinitis; Infections; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases