ew sternal fixation device study
Phase 4
- Conditions
- Cardiovascular Diseases
- Registration Number
- JPRN-jRCTs032180146
- Lead Sponsor
- Arai Hirokuni
- Brief Summary
Corrugated plate insertion resulted in significantly suppressed sternal displacement in both the anteroposterior and lateral directions. The use of corrugated plate insertion results in safe and easy sternal reinforcement without adverse events, and sternal healing can be accelerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Adult patients who undergo cardiovascular surgery with full sternotomy
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 <br>Dihisecnce, Bone union, and CBDA; Cortical bone density area (CT scan): 2weeks, 3months, and 6months after surgery <br>Sternal infection and Pain score: 1week, 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery <br>Quality of Life: 2weeks, 3weeks, 6weeks, 3months, and 6months after surgery