NCT06660186 · University Hospitals Cleveland Medical Center
Sternal Plating High Risk
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Kidney disease with GFR \>30 ml/min per 1.73m2
- Radiation therapy
- 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
- Delayed sternal closure
- Surgical complications
- Any criteria precluding RPF or WC
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 30, 2026 · Source of record for eligibility and locations