Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery
Not Applicable
- Conditions
- Patients who undergo cardiovascular surgery with full sternotomy
- Registration Number
- JPRN-UMIN000025763
- Lead Sponsor
- Tokyo Medical And Dental University, University Hospital of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Not provided
Exclusion Criteria
Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Displacement of sternal halves (CT scan): 6 months after surgery
- Secondary Outcome Measures
Name Time Method Displacement of sternal halves (CT scan): 2weeks and 3 months after surgery Dihisecnce, Bone union, and CBDA; Cortical bone density area (CT scan): 2weeks, 3months, and 6months after surgery Sternal infection and Pain score: 1week, 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery Quality of Life: 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery