Heart Diseases Clinical Trial
— ClosureOfficial title:
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
NCT number | NCT03289104 |
Other study ID # | 20160921 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2018 |
Est. completion date | September 2020 |
Verified date | December 2018 |
Source | Ottawa Heart Institute Research Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postoperative pain.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient age = 18 years - Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve replacement, mitral valve replacement/repair, or ascending aorta replacement. - Patient undergoing elective or urgent surgery - Ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: - Patients undergoing emergent cardiac surgery - Severe congestive heart failure (NYHA class III or IV) at enrollment - Prior cardiac surgery - Patients undergoing ventricular assist device insertion or heart transplantation - Patients with a known metal allergy or allergy to ZIPFIX implant - Patients who refuses consent - Patients who are unable to follow post-operative instructions - Prior history of significant bleeding that might be expected to recur with cardiac surgery - Dementia with a mini mental status examination (MMSE) score of < 20 - Extra cardiac illness that is expected to limit survival to less than 5 years - Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal - Concurrent enrollment in another clinical trial - Geographic inaccessibility for follow-up visits required by the protocol - Prisoners or institutionalized individuals |
Country | Name | City | State |
---|---|---|---|
Canada | Division of Cardiac Surgery | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Heart Institute Research Corporation |
Canada,
Grapow MT, Melly LF, Eckstein FS, Reuthebuch OT. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation. J Cardiothorac Surg. 2012 Jun 25;7:59. doi: 10.1186/1749-8090-7-59. — View Citation
Karamlou T, Jacobs ML, Pasquali S, He X, Hill K, O'Brien S, McMullan DM, Jacobs JP. Surgeon and center volume influence on outcomes after arterial switch operation: analysis of the STS Congenital Heart Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):904-11. doi: 10.1016/j.athoracsur.2014.04.093. Epub 2014 Jul 25. — View Citation
Kozower BD, Sheng S, O'Brien SM, Liptay MJ, Lau CL, Jones DR, Shahian DM, Wright CD. STS database risk models: predictors of mortality and major morbidity for lung cancer resection. Ann Thorac Surg. 2010 Sep;90(3):875-81; discussion 881-3. doi: 10.1016/j.athoracsur.2010.03.115. — View Citation
Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. — View Citation
Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. — View Citation
Melly L, Gahl B, Meinke R, Rueter F, Matt P, Reuthebuch O, Eckstein FS, Grapow MT. A new cable-tie-based sternal closure device: infectious considerations. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):219-23; discussion 223-4. doi: 10.1093/icvts/ivt183. Epub 2013 Apr 26. — 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
Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. Epub 2006 Apr 25. — View Citation
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
Stelly MM, Rodning CB, Stelly TC. Reduction in deep sternal wound infection with use of a peristernal cable-tie closure system: a retrospective case series. J Cardiothorac Surg. 2015 Nov 14;10:166. doi: 10.1186/s13019-015-0378-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sternal bone healing | Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale. | 3 months after surgery | |
Secondary | Post-operative pain | A patient's subjective assessment of their pain after surgery. | Within 1 week of surgery | |
Secondary | Use of narcotics | A patient's use of narcotic pain medication. To assess this measure, the proportion of patients in each group using narcotic pain medication will be compared. | In the first 6 months after surgery | |
Secondary | Sternal instability | Clinical assessment of patient's sternum stability after surgery | In the first 6 months after surgery | |
Secondary | Sternal wound infection | The presence of sternal wound infection after surgery, confirmed by wound cultures | In the first 6 months after surgery | |
Secondary | Cost | An approximation of the comparative cost of the ZipFix system versus sternal wires, which will be approximated by comparing the duration of hospital stay between groups; the use of narcotic pain medication between groups; and the rate of sternal wound infection between groups. | In the first 6 months after surgery. |
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