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Sternal Plating High Risk

Sternal Plating High Risk

Recruiting
18-89 years
All
Phase N/A

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Overview

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.

Eligibility

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

Study details
    Heart Diseases

NCT06660186

University Hospitals Cleveland Medical Center

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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