<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03289104</url>
  </required_header>
  <id_info>
    <org_study_id>20160921</org_study_id>
    <nct_id>NCT03289104</nct_id>
  </id_info>
  <brief_title>Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX</brief_title>
  <acronym>Closure</acronym>
  <official_title>Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine whether sternal reconstruction using the ZIPFIX&#xD;
      system compared to standard wire cerclage could improve bone healing, patient function, and&#xD;
      decreased postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite a longer time for bone healing and functional recovery, median sternotomy is still&#xD;
      the most common approach in cardiac surgery. Sternal closure has traditionally been wire&#xD;
      cerclage using stainless steel wires, however, new sternal fixation devices have been&#xD;
      developed to improve sternal union. Rigid sternal fixation, although very costly, has&#xD;
      demonstrated to be superior to standard wire cerclage both in clinical and biomechanical&#xD;
      studies. Although improved sternal healing was observed with rigid plate fixation in a&#xD;
      randomized controlled trial in high risk patients, the wound complication rate with plate&#xD;
      fixation was almost double that of wire cerclage albeit not statistically significant.&#xD;
&#xD;
      A novel sternal closure system denoted the sternal ZIPFIX system (DePuySynthes, Companies of&#xD;
      Johnson and Johnson, West Over, PA, US) is biocompatible Poly-Ether-Ether-Ketone implant that&#xD;
      was developed for fast and reliable sternal fixation following median sternotomy. First&#xD;
      published case series utilized the sternal ZIPFIX System demonstrating effective sternal&#xD;
      stability at 30 days. Another study has demonstrated no significant difference in the&#xD;
      incidence of sternal wound infection following the ZIPFIX system compared to standard wire&#xD;
      cerclage while Stelly et al., 2015 demonstrated reduced risk of deep sternal wound infection&#xD;
      for patients using ZIPFIX. The ZIPFIX system demonstrates a higher resistance of fatigue&#xD;
      failure and has a larger implant-to-bone contact area compared to stainless steel wires&#xD;
      thereby reducing the risk of bone cut through. Placement of the cable ties are done similar&#xD;
      to wire cerclage thereby not affecting time for sternal closure and training.&#xD;
&#xD;
      The objective of this study is to determine whether sternal reconstruction using the ZIPFIX&#xD;
      system compared to standard wire cerclage would improve bone healing, patient function, and&#xD;
      decrease postoperative pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study terminated due to inadequate funding.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sternal bone healing</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>Within 1 week of surgery</time_frame>
    <description>A patient's subjective assessment of their pain after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of narcotics</measure>
    <time_frame>In the first 6 months after surgery</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sternal instability</measure>
    <time_frame>In the first 6 months after surgery</time_frame>
    <description>Clinical assessment of patient's sternum stability after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sternal wound infection</measure>
    <time_frame>In the first 6 months after surgery</time_frame>
    <description>The presence of sternal wound infection after surgery, confirmed by wound cultures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>In the first 6 months after surgery.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Sternal Injury</condition>
  <condition>Cardiac Surgery</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Steel Wires</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this arm, patients will have their sternum closed with steel wires.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZipFix Sternal Closure System (Plastic Cables)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, patients will have their sternum closed with the ZipFix system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Steel Wires</intervention_name>
    <description>Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.</description>
    <arm_group_label>Steel Wires</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ZipFix Sternal Closure System</intervention_name>
    <description>Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.</description>
    <arm_group_label>ZipFix Sternal Closure System (Plastic Cables)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age ≥ 18 years&#xD;
&#xD;
          -  Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve&#xD;
             replacement, mitral valve replacement/repair, or ascending aorta replacement.&#xD;
&#xD;
          -  Patient undergoing elective or urgent surgery&#xD;
&#xD;
          -  Ability to understand study procedures and to comply with them for the entire length&#xD;
             of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing emergent cardiac surgery&#xD;
&#xD;
          -  Severe congestive heart failure (NYHA class III or IV) at enrollment&#xD;
&#xD;
          -  Prior cardiac surgery&#xD;
&#xD;
          -  Patients undergoing ventricular assist device insertion or heart transplantation&#xD;
&#xD;
          -  Patients with a known metal allergy or allergy to ZIPFIX implant&#xD;
&#xD;
          -  Patients who refuses consent&#xD;
&#xD;
          -  Patients who are unable to follow post-operative instructions&#xD;
&#xD;
          -  Prior history of significant bleeding that might be expected to recur with cardiac&#xD;
             surgery&#xD;
&#xD;
          -  Dementia with a mini mental status examination (MMSE) score of &lt; 20&#xD;
&#xD;
          -  Extra cardiac illness that is expected to limit survival to less than 5 years&#xD;
&#xD;
          -  Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all&#xD;
             women not clearly menopausal&#xD;
&#xD;
          -  Concurrent enrollment in another clinical trial&#xD;
&#xD;
          -  Geographic inaccessibility for follow-up visits required by the protocol&#xD;
&#xD;
          -  Prisoners or institutionalized individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Ruel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Cardiac Surgery</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <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>
    <PMID>25069686</PMID>
  </reference>
  <reference>
    <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>
    <PMID>20732512</PMID>
  </reference>
  <reference>
    <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>
    <PMID>17670585</PMID>
  </reference>
  <reference>
    <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>
    <PMID>16122464</PMID>
  </reference>
  <reference>
    <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>
    <PMID>17888985</PMID>
  </reference>
  <reference>
    <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>
    <PMID>14726062</PMID>
  </reference>
  <reference>
    <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>
    <PMID>15296898</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22731778</PMID>
  </reference>
  <reference>
    <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>
    <PMID>23624983</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26577944</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>December 13, 2018</last_update_submitted>
  <last_update_submitted_qc>December 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ottawa Heart Institute Research Corporation</investigator_affiliation>
    <investigator_full_name>Marc Ruel MD MPH FRCSC</investigator_full_name>
    <investigator_title>Chief Cardiac Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03289104
org study id: 20160921
nct id: NCT03289104
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Sternal bone healing
time frame: 3 months after surgery
description: Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.
measure: Post-operative pain
time frame: Within 1 week of surgery
description: A patient's subjective assessment of their pain after surgery.
measure: Use of narcotics
time frame: In the first 6 months after surgery
description: 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.
measure: Sternal instability
time frame: In the first 6 months after surgery
description: Clinical assessment of patient's sternum stability after surgery
measure: Sternal wound infection
time frame: In the first 6 months after surgery
description: The presence of sternal wound infection after surgery, confirmed by wound cultures
measure: Cost
time frame: In the first 6 months after surgery.
description: 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.
arm group label: Steel Wires
arm group type: Active Comparator
description: In this arm, patients will have their sternum closed with steel wires.
arm group label: ZipFix Sternal Closure System (Plastic Cables)
arm group type: Experimental
description: In this arm, patients will have their sternum closed with the ZipFix system.
intervention type: Device
intervention name: Steel Wires
description: Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.
arm group label: Steel Wires
intervention type: Device
intervention name: ZipFix Sternal Closure System
description: Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.
arm group label: ZipFix Sternal Closure System (Plastic Cables)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Ruel, MD, MPH
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
facility: 
country: Canada
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.
PMID: 25069686
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.
PMID: 20732512
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.
PMID: 17670585
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.
PMID: 16122464
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.
PMID: 17888985
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.
PMID: 14726062
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.
PMID: 15296898
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.
PMID: 22731778
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.
PMID: 23624983
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.
PMID: 26577944
responsible party type: Principal Investigator
investigator affiliation: Ottawa Heart Institute Research Corporation
investigator full name: Marc Ruel MD MPH FRCSC
investigator title: Chief Cardiac Surgeon
mesh term: Heart Diseases
sharing ipd: No