Sternal Closure Techniques for Heart Disease

Overseen By Stacey Mazzurco

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marc Pelletier

Must not be taking: Chronic narcotics

Disqualifiers: Active malignancy, NYHA Class IV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 10 days

250 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using chronic narcotics, you may not be eligible to participate.

What data supports the effectiveness of the treatment Rigid Sternal Fixation, Wire Cerclage for heart disease?

Research shows that using rigid plate fixation for closing the breastbone after heart surgery can lead to better healing and fewer complications compared to traditional wire cerclage. This method has been found to improve patient outcomes and is cost-effective over time. ^{1 2 3 4 5}

Is sternal closure using rigid fixation or wire cerclage safe?

Research shows that rigid sternal fixation may be safer than traditional wire cerclage, as it reduces the risk of complications like poor sternal healing and wound issues. However, rigid fixation has its own set of potential complications that need to be considered. ^{1 2 3 5 6}

How does the treatment Rigid Sternal Fixation differ from Wire Cerclage for sternal closure?

Rigid Sternal Fixation uses plates to hold the sternum (breastbone) together after surgery, which can lead to better healing and fewer complications compared to the traditional method of using wire cerclage. This approach is particularly beneficial for high-risk patients and has been shown to be cost-neutral over time. ^{1 2 3 4 6}

Research Team

Marc Pelletier, MD

Principal Investigator

University Hospitals

Rakesh Arora, MD

Principal Investigator

University Hospitals

Eligibility Criteria

This trial is for adults over 18 with heart disease who are scheduled for open-heart surgery and at high risk of sternal wound complications. Specific eligibility details were not provided, so interested individuals should inquire further about inclusion and exclusion criteria.

Inclusion Criteria

I have had or will have BITA grafting.

I am having heart surgery and have two or more specific health issues.

My chest was opened in a way that did not split my breastbone down the middle.

Exclusion Criteria

I currently have cancer.

Involvement in another interventional clinical trial (non-registry)

Compliance concern

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo open heart surgery with either rigid plate fixation or wire cerclage for sternal closure

Up to 10 days

In-hospital stay

Follow-up

Participants are monitored for sternal healing, adverse events, and quality of life changes

6 months

Multiple visits including postoperative days 1, 3, discharge, 1 month, and 6 months

Treatment Details

Interventions

• Rigid Sternal Fixation
• Wire Cerclage

Trial Overview The study compares two methods of closing the sternum after open-heart surgery: Rigid Sternal Fixation using a Sternal Plate versus Wire Cerclage. The goal is to evaluate which technique better prevents sternal wound complications.

Participant Groups

Group I: Rigid Sternal Fixation Experimental Treatment 1 Intervention

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.

Group II: Wire Cerclage Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Marc Pelletier

Lead Sponsor

Trials

3

Recruited

270+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Stryker Nordic

Industry Sponsor

Trials

35

Recruited

4,400+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Rigid Plate Fixation Versus Wire Cerclage for Sternotomy After Cardiac Surgery: A Meta-Analysis. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Rigid Plate Fixation Versus Wire Cerclage: Patient-Reported and Economic Outcomes From a Randomized Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Use of longitudinal rigid sternal fixation in prevention and treatment of wound complications among high-risk patients after cardiac surgery. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized, multicenter trial comparing sternotomy closure with rigid plate fixation to wire cerclage. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Kryptonite bone cement prevents pathologic sternal displacement. [2010]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Surgical outcomes of sternal rigid plate fixation from 2005 to 2016 using the American College of Surgeons-National Surgical Quality Improvement Program database. [2020]