RecruitingNot ApplicableNCT06660186

Sternal Plating High Risk

Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients

Sponsor

University Hospitals Cleveland Medical Center

Enrollment

250 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

Heart Diseases

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

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria18

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
Off-midline sternotomy
BITA grafting
CPB time ≥120 minutes
Transverse sternal fracture

Exclusion Criteria15

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
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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Interventions

DEVICERigid Sternal Fixation

The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.

DEVICEWire Cerclage

The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.