Cardiovascular Diseases
Conditions
Interventions
Sternal closure with new sternal fixation device, which is inserted in bone marrow, followed by wire cerclage
Sponsors
Arai Hirokuni
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients who undergo cardiovascular surgery with full sternotomy
Exclusion criteria
Exclusion criteria: Emergency, Diabetes (HbA1c is 8.0% and more), Hemodialysis, Steroid, Immunosuppressant, Severe COPD, Ventricular assist device, Infectious endocarditis, and Pacemaker lead infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Displacement of sternal halves (CT scan): 6 months after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactKiyotoshi Oishi
Tokyo Medical and Dental University
Outcome results
None listed