JPRN-jRCTs032180146CompletedPhase 4
Randomized controlled trial evaluating the effect of new sternal fixation device for the patients who undergo open heart surgery - New sternal fixation device study
Arai Hirokuni0 sites70 target enrollmentStarted: February 21, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 70
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
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
Investigators
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