Clinical trial NCT03289104: Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
Official title: Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sternal Injury
Cardiac Surgery
Heart Diseases
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Despite a longer time for bone healing and functional recovery, median sternotomy is still the most common approach in cardiac surgery. Sternal closure has traditionally been wire cerclage using stainless steel wires, however, new sternal fixation devices have been developed to improve sternal union. Rigid sternal fixation, although very costly, has demonstrated to be superior to standard wire cerclage both in clinical and biomechanical studies. Although improved sternal healing was observed with rigid plate fixation in a randomized controlled trial in high risk patients, the wound complication rate with plate fixation was almost double that of wire cerclage albeit not statistically significant.

A novel sternal closure system denoted the sternal ZIPFIX system (DePuySynthes, Companies of Johnson and Johnson, West Over, PA, US) is biocompatible Poly-Ether-Ether-Ketone implant that was developed for fast and reliable sternal fixation following median sternotomy. First published case series utilized the sternal ZIPFIX System demonstrating effective sternal stability at 30 days. Another study has demonstrated no significant difference in the incidence of sternal wound infection following the ZIPFIX system compared to standard wire cerclage while Stelly et al., 2015 demonstrated reduced risk of deep sternal wound infection for patients using ZIPFIX. The ZIPFIX system demonstrates a higher resistance of fatigue failure and has a larger implant-to-bone contact area compared to stainless steel wires thereby reducing the risk of bone cut through. Placement of the cable ties are done similar to wire cerclage thereby not affecting time for sternal closure and training.

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage would improve bone healing, patient function, and decrease postoperative pain.

Eligibility criteria: 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

Primary outcomes:
measure: Sternal bone healing
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Post-operative pain
timeFrame: Within 1 week of surgery
measure: Use of narcotics
timeFrame: In the first 6 months after surgery
measure: Sternal instability
timeFrame: In the first 6 months after surgery
measure: Sternal wound infection
timeFrame: In the first 6 months after surgery
measure: Cost
timeFrame: In the first 6 months after surgery.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Division of Cardiac Surgery
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Marc Ruel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
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. doi: 10.1016/j.athoracsur.2005.03.089.
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. doi: 10.1016/j.athoracsur.2007.05.023.
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. doi: 10.1016/s0003-4975(03)01468-1.
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. doi: 10.1016/j.ejcts.2004.04.038.
citation: 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.
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.
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.