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Procedure

Sternal Closure Techniques for Heart Disease

N/A

Waitlist Available

Led By Rakesh Arora, MD

Research Sponsored by Marc Pelletier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BITA grafting

Undergoing cardiac surgery through sternotomy with ≥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

Must not have

Active malignancy

NYHA Class IV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking for volunteers who have heart disease and are scheduled for open heart surgery. The study will compare two techniques used to close the sternum after surgery. Participants must be over 18 and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include issues related to the surgical site such as pain, infection, or poor healing at the bone where the chest was opened. However, specific side effects associated with each method have not been detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had or will have BITA grafting.

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

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

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I have a broken breastbone.

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My heart-lung machine use was 2 hours or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have cancer.

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My heart condition severely limits my physical activity.

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My chest surgery was not through the standard midline cut.

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I had heart surgery with a very narrow chest bone cut.

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I am currently experiencing bleeding.

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I have had complications from surgery.

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My kidney function is severely reduced.

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I need urgent or rescue surgery.

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My chest was not closed immediately after heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of sternal wound complications as measured by patient/physician report

Sternal healing as measured by CT scan

Total cost

+1 more

Secondary study objectives

Change in pain as measured by the Wong-Baker pain scale

Change in prescribed narcotic use as measured by patient report

Change in quality of life as measured by the EuroQol EQ-5D-5L

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Rigid Sternal FixationExperimental Treatment1 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 CerclageActive Control1 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.

0 / 14Eligibility criteria met