Actively Recruiting
Sternal Plating High Risk
Led by University Hospitals Cleveland Medical Center · Updated on 2026-04-30
250
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
Sponsors
U
University Hospitals Cleveland Medical Center
Lead Sponsor
S
Stryker Nordic
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Sternal Plating High Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 89 years
- Undergoing cardiac surgery through sternotomy
- Having two or more risk factors: diabetes mellitus, severe COPD, chronic steroid use, immunosuppression, redo sternotomy, kidney disease with GFR >30 ml/min/1.73m2, radiation therapy, BMI ≥35, high risk of delirium, or heavy alcohol use
- Off-midline sternotomy
- BITA grafting
- Cardiopulmonary bypass time ≥120 minutes
- Transverse sternal fracture
You will not qualify if you...
- Active malignancy
- Chronic narcotic use
- NYHA Class IV heart failure
- Known nickel metal allergy
- Compliance concerns
- Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
- Participation in another interventional clinical trial (non-registry)
- Any condition preventing use of rigid plate fixation or wire cerclage
- Emergent or salvage surgery
- Non-standard sternotomies
- Sternotomy with bony margin less than 2 mm
- Bleeding or surgical complications
- Delayed sternal closure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
S
Stacey Mazzurco
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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