NCT06660186NARecruiting
Sternal Plating High Risk
University Hospitals Cleveland Medical Center
Start Date
3/12/2026
Completion Date
6/30/2027
Summary
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 Criteria
Age Range: 18 years to 89 years
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
Interventions
DEVICE
Rigid Sternal Fixation
DEVICE
Wire Cerclage
Conditions
Heart Diseases
Locations
University Hospitals
Cleveland, Ohio 44106
United States