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Montage-Enhanced Sternal Closure

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ClinicalTrials.gov Identifier: NCT03365843
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge.

This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.


Condition or disease Intervention/treatment Phase
Sternal Closure Device: Montage bone putty Other: Conventional Sternal Closure Phase 2

Detailed Description:

Patients undergoing cardiac surgery who are participating in the study will be randomized to either conventional wire cerclage or conventional wire closure plus the use of Montage bone putty. Patients will be followed post-operatively Day 3, 5 and at discharge as well as weeks 2, 4, 6 and months 3, 6 and 12.

Each visit will include: Pain assessment, wound assessment, sternal assessment, analgesic/antibiotic use, spirometry testing, quality of life questionaries (EQ-5D/HAQ) and determination of any adverse events. Chest x-rays will done at discharge and 3, 6, and 12 months to look at sternal healing.

This pilot study will include a total of 65 patient (40 conventional + putty / 20 conventional/ 5 initial open label with putty).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single centre, double-blind clinical study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The participants, study coordinator and care-givers are blinded to the assigned treatment arm. Participants may be able to guess which treatment group they have been assigned. This will be assessed at the end of the study by asking participants to identify the group to which they think they have been assigned.
Primary Purpose: Treatment
Official Title: Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery
Anticipated Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions

Arm Intervention/treatment
Experimental: Montage bone putty
Sternal closure with conventional wire cerclage plus Montage bone putty
Device: Montage bone putty
Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
Other: Conventional Sternal Closure
Closure of sternum with standard wire cerclage.
Active Comparator: Conventional Sternal Closure
Conventional wire cerclage sternal closure only -- standard care.
Other: Conventional Sternal Closure
Closure of sternum with standard wire cerclage.


Outcome Measures

Primary Outcome Measures :
  1. Recovery of Respiratory Function [ Time Frame: Intervention to 6 weeks post-operative ]
    The recovery of pulmonary functional capacity as measured by the return of forced vital capacity (FVC) to 80% or greater of the pre-operative baseline FVC measurement.

  2. Radiographic Sternal Integrity [ Time Frame: Intervention to 12 months post-operative ]
    No radiographic evidence of bony instability as assessed through serial chest x-rays

  3. Sternal Revision [ Time Frame: Intervention to 12 months post-operative ]
    Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.


Secondary Outcome Measures :
  1. Post-operative Pain Assessment [ Time Frame: Baseline to 12 months post - operative. ]
    Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups

  2. Rate of post-operative recovery [ Time Frame: Baseline to 12 months post-operative ]
    Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool

  3. Rate of post-operative recovery [ Time Frame: Baseline to 12 months post-operative ]
    Rate of post-operative recovery as measured by physical functioning (HAQ) standardized assessment tool

  4. Sternal Wound Infections [ Time Frame: Baseline to 12 months post-operative ]
    Frequency of sternal wound infections (superficial and deep) between groups

  5. Pulmonary Complications [ Time Frame: Baseline to 6 weeks post-operative ]
    Post-operative pulmonary complications between groups

  6. Health Services resource usage [ Time Frame: Baseline to 12 months post-operative ]
    To compare the burden of health services resource usage between groups (total cost estimate)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • undergoing non-emergent cardiac surgery ( cabg only or one valve procedure)
  • full median sternotomy approach, with or without cardiopulmonary bypass
  • English speaking
  • geographically accessible
  • written consent

Exclusion Criteria:

  • Recent CPR
  • previous cardiac surgery
  • emergency surgery ( within 24 hrs of assessment)
  • chronic lung disease
  • history of bleeding disorder
  • currently taking Vitamin E supplements
  • recent antiplatelet therapy
  • excessively poor baseline health-related quality of life or physical functioning
  • previous radiotherapy to chest, or on immunosuppressive drugs or current immunosuppressive condition
  • active significant systemic infection, history of recurrent infections,
  • cognitive impairment ( confusion, dementia, Alzheimer's, current substance abuse)
  • history of malignancy within the past year
  • recent history of significant alcohol or drug abuse
  • females who are pregnant, nursing, or child bearing potential who are not practicing a highly reliable birth control method
  • postsurgical life expectancy of less than 90 days
  • moderate to severe pectus deformity
  • participation in another study
Contacts and Locations

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): NCT03365843


Contacts
Contact: Paul WM Fedak, MD, PhD 403-944-5931 paul.fedak@gmail.com

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Abyrx Inc.
Investigators
Principal Investigator: Paul WM Fedak, MD, PhD University of Calgary
More Information

Responsible Party: Dr. Paul Fedak, Professor and Cardiac Surgeon, University of Calgary
ClinicalTrials.gov Identifier: NCT03365843     History of Changes
Other Study ID Numbers: REB17-1399
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Dr. Paul Fedak, University of Calgary:
Cardiac surgery
Sternal closure