Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
51 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-03-31
Study Completion Date
2009-07-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Sternal Wound Infection
Mediastinitis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
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1
Conventional wires only
Group Type
ACTIVE_COMPARATOR
Conventional wire closure
Intervention Type
DEVICE
Conventional wire closure of sternum
2
Rapid Sternal Closure System supplemented with wires
Group Type
EXPERIMENTAL
Rapid Sternal Closure System
Intervention Type
DEVICE
Sternal talons will be used and supplemented with wires
Interventions
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Rapid Sternal Closure System
Sternal talons will be used and supplemented with wires
Intervention Type
DEVICE
Conventional wire closure
Conventional wire closure of sternum
Intervention Type
DEVICE
Eligibility Criteria
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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.
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.
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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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KLS Martin, L.P.
UNKNOWN
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
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KLS Martin, L.P.
Principal Investigators
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Elliott Bennett-Guerrero, M. D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Site Status
Countries
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United States
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
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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.
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BACKGROUND
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.
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BACKGROUND
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.
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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. doi: 10.1136/hrt.2006.103002. Epub 2007 Feb 19.
Reference Type
BACKGROUND
Other Identifiers
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PRO00006260
Identifier Type: -
Identifier Source: org_study_id
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