Rigid plate versus wire closure of the breastbone after open-heart surgery for high-risk adults
Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06660186 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.