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Sternal Plating High Risk

RecruitingNAAges 18 Years - 89 YearsAllUniversity Hospitals Cleveland Medical Center
NCT06660186 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.

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📋 Eligibility rules (as published)
Preoperative Inclusion Criteria * Adults (age range: 18-89) * Undergoing cardiac surgery through sternotomy -≥2 risk factors: * Diabetes mellitus * Severe COPD * Chronic steroid use * Immunosuppression * Redo sternotomy * Chronic * Kidney disease with GFR \>30 ml/min per 1.73m2 * Radiation therapy * BMI≥35 * High-risk of delirium * Heavy alcohol use Preoperative Exclusion Criteria * Active malignancy * Chronic narcotic use * NYHA Class IV * Known nickel metal allergy * Compliance concern * eGFR\<30 ml/min per 1.73m2 * Involvement in another interventional clinical trial (non-registry) * Any criteria precluding RPF or WC Operative Inclusion Criteria * Off-midline sternotomy * BITA grafting * CPB time ≥120 minutes * Transverse sternal fracture Operative Exclusion Criteria * Emergent or emergent salvage surgery * Non-standard sternotomies * Sternotomy with bony margin \<2 mm * Bleeding * Delayed sternal closure * Surgical complications * Any criteria precluding RPF or WC
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What it tests

  • Rigid Sternal Fixation
  • Wire Cerclage
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Where

1 site
University Hospitals
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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