Rigid plate versus wire closure of the breastbone after open-heart surgery for high-risk adults
Official title: Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
Run by University Hospitals Cleveland Medical Center · NCT06660186 · Data updated 2026-11-12
This trial tests whether using a rigid sternal plate instead of traditional wire closure lowers wound complications and pain after open-heart surgery in adults at higher risk for sternal problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | March 12, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT06660186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–89 undergoing sternotomy for cardiac surgery who have at least two risk factors for sternal wound complications (for example diabetes, COPD, obesity, or prior sternotomy) and meet operative criteria are the ideal candidates.
✕Probably not a fit
Patients undergoing emergent surgery, with severe kidney failure (eGFR <30), active malignancy, nickel allergy, chronic narcotic use, or other exclusions that preclude either fixation method are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for open-heart surgery through a sternotomy who have two or more risk factors for sternal wound complications are eligible for enrollment. At the time of surgery participants receive either rigid sternal plate fixation or standard wire cerclage closure and are followed for wound healing, infection, pain, and sternal stability. The protocol excludes emergent operations and patients with conditions that preclude either fixation method such as severe kidney failure, active malignancy, or known metal allergy. All procedures and follow-up visits are conducted at University Hospitals in Cleveland, Ohio.
Why it matters
Potential benefit: If successful, the rigid plate approach could reduce sternal infections, improve chest stability, decrease pain, and speed recovery for high-risk patients.
How similar studies have gone: Prior reports and device registries have suggested rigid sternal fixation can reduce sternal instability and infections in selected high-risk groups, but randomized and consistent evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University Hospitals
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Marc Pelletier, MD — University Hospitals
- Study coordinator: Stacey Mazzurco
- Email: Stacey.Mazzurco@UHhospitals.org
- Phone: 216-844-3130
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.