Status:
COMPLETED
Sternalock Versus Wires for Sternal Closure Study
Lead Sponsor:
University of Melbourne
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Cardiac Surgery
Sternal Closure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Design: Investigator Initiated Prospective Randomised Trial Study Centre's: Melbourne Private Hospital Royal Melbourne Hospital Study Hypothesis: Use of the SternaLock 360 will reduce the inciden...
Detailed Description
Introduction/Background Information Since the inception of cardiac surgery in the early 1960s, division of the sternum has provided the superior access to cardiac structures. Cardiac surgery may invol...
Eligibility Criteria
Inclusion
- Age ≥ 18 year old Elective cardiac surgery Primary cardiac surgical procedure No evidence of infection at time of surgery Sufficient English language to complete the Postoperative Quality of Recovery Survey
Exclusion
- Previous sternotomy (redo) Clinical sternal deformity Home locality preventing follow-up (e.g. remote regional, interstate or overseas patient)
Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03282578
Start Date
October 5 2017
End Date
November 25 2018
Last Update
April 17 2019
Active Locations (1)
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1
Melbourne Private Hospital
Melbourne, Victoria, Australia, 3050