Status:
UNKNOWN
Montage-Enhanced Sternal Closure
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Abyrx, Inc.
Conditions:
Sternal Closure
Eligibility:
All Genders
19-79 years
Phase:
PHASE2
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. Aug...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03365843
Start Date
October 1 2018
End Date
December 1 2022
Last Update
September 28 2021
Active Locations (1)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9