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Trial record 77 of 245 for:    "ottawa heart institute"

Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX (Closure)

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ClinicalTrials.gov Identifier: NCT03289104
Recruitment Status : Withdrawn (Study terminated due to inadequate funding.)
First Posted : September 20, 2017
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation

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.

Condition or disease Intervention/treatment Phase
Sternal Injury Cardiac Surgery Heart Diseases Device: Steel Wires Device: ZipFix Sternal Closure System Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Active Comparator: Steel Wires
In this arm, patients will have their sternum closed with steel wires.
Device: Steel Wires
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.

Experimental: ZipFix Sternal Closure System (Plastic Cables)
In this arm, patients will have their sternum closed with the ZipFix system.
Device: ZipFix Sternal Closure System
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.




Primary Outcome Measures :
  1. Sternal bone healing [ Time Frame: 3 months after surgery ]
    Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.


Secondary Outcome Measures :
  1. Post-operative pain [ Time Frame: Within 1 week of surgery ]
    A patient's subjective assessment of their pain after surgery.

  2. Use of narcotics [ Time Frame: In the first 6 months after surgery ]
    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.

  3. Sternal instability [ Time Frame: In the first 6 months after surgery ]
    Clinical assessment of patient's sternum stability after surgery

  4. Sternal wound infection [ Time Frame: In the first 6 months after surgery ]
    The presence of sternal wound infection after surgery, confirmed by wound cultures

  5. Cost [ Time Frame: In the first 6 months after surgery. ]
    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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289104


Locations
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Canada, Ontario
Division of Cardiac Surgery
Ottawa, Ontario, Canada, K1Y4W7
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Marc Ruel, MD, MPH Ottawa Heart Institute Research Corporation

Publications:

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Responsible Party: Marc Ruel MD MPH FRCSC, Chief Cardiac Surgeon, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03289104     History of Changes
Other Study ID Numbers: 20160921
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases