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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for closing the breastbone after open-heart surgery: rigid plates (Rigid Sternal Fixation, SternalPlate system) and stainless steel wires (Wire Cerclage). The researchers aim to determine which method better reduces post-surgery complications. Individuals with heart disease who have two or more risk factors, such as diabetes, severe lung issues, or heavy alcohol use, and are scheduled for open-heart surgery may be suitable candidates for this trial. Participants will contribute to research that could improve recovery after heart surgery. As an unphased trial, this study offers a unique opportunity to advance innovative research that may enhance surgical outcomes for future patients.

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 prior data suggests that these sternal closure techniques are safe for heart surgery patients?

Studies have shown that the rigid sternal fixation method, which uses a SternalPlate system to close the breastbone, is generally well-tolerated. Research indicates that patients usually experience low pain levels and better breastbone stability after surgery. In rare cases, about 2.4% of patients needed the plate removed, typically among those at higher risk.

For the wire cerclage method, which uses stainless steel wires to hold the breastbone together, the sources provided do not specify negative effects. Both methods have been used in many surgeries, and the choice often depends on the patient's specific needs and the surgeon's expertise.

Overall, both methods are considered safe, with rigid sternal fixation showing some advantages in recovery and healing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these sternal closure techniques because they offer potentially better outcomes for patients recovering from heart surgery. Rigid Sternal Fixation uses the SternalPlate system, which consists of implants designed to provide more stable and secure closure of the breastbone compared to traditional methods. This could lead to faster recovery and less pain. On the other hand, Wire Cerclage, the current standard of care, uses stainless steel wires, which are effective but may not offer the same level of stability. By comparing these two methods, researchers hope to find out if Rigid Sternal Fixation can improve surgical results and patient comfort.

What evidence suggests that these sternal closure techniques are effective for heart disease surgery?

This trial will compare two sternal closure techniques: Rigid Sternal Fixation and Wire Cerclage. Research has shown that rigid sternal fixation can be more effective than wire cerclage for closing the breastbone after heart surgery. Specifically, only about 2.1% of patients with rigid fixation developed serious infections requiring surgery, which is a positive outcome. Rigid fixation often leads to quicker healing and shorter hospital stays compared to wire cerclage. Patients also tend to experience less pain after surgery with rigid fixation. These findings suggest that rigid sternal fixation could be a more reliable option for reducing complications after breastbone surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Marc Pelletier, MD

Principal Investigator

University Hospitals

Rakesh Arora, MD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

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

Involvement in another interventional clinical trial (non-registry)

I currently have cancer.

Compliance concern

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11468325/

Effectiveness of rigid plate fixation for sternal closure in ... Among the 48 patients, 1 (2.1%) developed DSWI requiring surgical treatment. Sternal fusion improved over time, with significant progression ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1443950625002100

Wire Cerclage Versus Rigid Plate Fixation: A Retrospective ... This study aimed to compare the incidence of sternal complications between patients receiving rigid plate fixation vs wire cerclage and thereby assess the cost ...

3. journals.lww.com journals.lww.com/annals-of-medicine-and-surgery/fulltext/2025/05000/outcomes_of_rigid_fixation_compared_to_wire.49.aspx

Outcomes of rigid fixation compared to wire closure after... Rigid fixation was found to be superior to the wire cerclage in regard to shorter hospital stay duration, sternal healing scores, postoperative pain up to 3 ...

4. opencardiovascularmedicinejournal.com opencardiovascularmedicinejournal.com/VOLUME/5/PAGE/148/FULLTEXT/

Rigid Sternal Fixation Improves Postoperative Recovery This retrospective study showed rigid sternal fixation was more frequently used in low risk young male patients, or high risk obese patients. Among these ...

5. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(24)00568-X/fulltext

Rigid Sternal Fixation and Enhanced Recovery for Opioid ... This single-center, retrospective, case-cohort study compared outcomes between median sternotomy patients (all comers) who underwent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11673957/

First Report on Rigid Plate Fixation for Enhanced Sternal ... Our findings are consistent with existing literature, with confirmed improved sternal stability and low pain scores after RPF in full sternotomy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1522294221001495

Adult Rigid Plate Fixation for Sternal Closure Earlier results from our study1 suggest that sternal plating system had to be removed in 2.4% of high-risk patients needing rigid sternal fixation with plating ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01317095

A Study of Sternal Closure After Open Heart Surgery: Rigid ... The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method ...

9. annalsthoracicsurgery.org annalsthoracicsurgery.org/article/S0003-4975(12)01863-2/fulltext

Sternal Closure With Rigid Plate Fixation Versus Wire ... Sternal healing was superior in rigid plate fixation patients at both 3 and 6 months. Mean computed tomography scores in the rigid plate fixation and wire ...