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New study tests if metal plates beat wires for heart surgery recovery

NCT ID NCT06660186

Disease control Sponsor: University Hospitals Cleveland Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two methods for closing the breastbone after open-heart surgery: rigid plate fixation (using a metal plate and screws) versus traditional wire cerclage (using stainless steel wires). The trial will enroll 250 adults at high risk for wound complications, such as those with diabetes, obesity, or steroid use. The goal is to see which technique leads to better bone healing and fewer complications like infections or wound separation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rigid Sternal Fixation (SternalPlate system) or Wire Cerclage
What this could lead to
If rigid plate fixation works better, it could reduce serious wound complications and improve recovery after open-heart surgery in high-risk patients.
What could go wrong
This is a single-center trial with 250 participants, so results may not apply to all patients. Both techniques are already used, so the difference may be small.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

heart disorder Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospitals

    RECRUITING

    Cleveland, Ohio, 44106, United States

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