Sternal Plating High Risk

Launched by UNIVERSITY HOSPITALS CLEVELAND MEDICAL CENTER · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to close the breastbone (sternum) after heart surgery, specifically for patients who have heart disease and are at higher risk for complications. After heart surgery, surgeons typically use either a rigid plate or wires to secure the sternum. The goal of the study is to see which method works better for patients at risk of developing problems with their sternal wound.

To participate in this study, you need to be an adult aged 18 to 89 and scheduled for heart surgery that involves opening the sternum. You must also have at least two risk factors, such as diabetes, severe lung disease, or a high body mass index (BMI). If you join the trial, you will receive one of the two methods for closing the sternum, and the researchers will monitor your recovery to see how well you heal. This trial is not yet recruiting participants, but it aims to help improve outcomes for patients undergoing heart surgery in the future.

Gender

ALL

Eligibility 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