ACTRN12622001422718
Not yet recruiting
未知
An Investigator Led Trial to Assess the Safety and Efficacy of the Waston Sternal Claw Fixation System against Standard of Care Wire Cerclage as an Advantageous Method of Median Sternotomy Closure
Professor Jayme Bennetts0 sites90 target enrollmentNovember 7, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Cardiothoracic Surgery
- Sponsor
- Professor Jayme Bennetts
- Enrollment
- 90
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients who undergo median sternotomy for any cardiac procedure
- •\-Patients aged 18\-80
- •\-Patients who have sufficient English language
- •\-Patients able to and willing to comply with all study procedures
- •\-Patient able to understand and provide informed consent
Exclusion Criteria
- •\-Patients allergic to heavy alloy
- •\-Patients undergoing re\-do procedure
- •\-Patients who have chronic steroid or narcotic use
- •\-Patients with a clinical sternal deformity
- •\-Pregnant women
- •\-Patients with a body mass index greater than or equal to 40
- •\-Patients with severe chronic obstructive airway disease
- •\-Patients with dialysis dependent renal failure.
- •\-Patients who have any of the following Sternal Claw contraindications:
- •oSevere mental disorder
Outcomes
Primary Outcomes
Not specified
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