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New implant may stop deadly infections after heart surgery

NCT ID NCT07470112

Prevention Sponsor: Zagazig University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether placing a gentamicin-soaked collagen sponge inside the chest during heart surgery can prevent surgical site infections in high-risk patients. About 142 people at high risk for infection (older adults, those with diabetes, obesity, or other conditions) took part. The implant is meant to reduce infections and improve healing of the breastbone.

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

142 people

The number who actually took part.

Started

May 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

20 to 70 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.

Inclusion Criteria:. Old age \> 60 years old. * Uncontrolled hypertension and diabetes mellitus patients. * Obesity (BMI\>30 kg/m2). * Female gender. * Osteoporosis of the sternum. * Chronic Obstructive Pulmonary Disease (COPD). * Steroid therapy or immunosuppression. * Intraoperative intra-aortic balloon pump (IABP) use. * Re-exploration for bleeding. * Long time of cardiopulmonary bypass (\>180 minutes). * Redo cardiac surgery operation (elective ) Exclusion Criteria: * o Patients with known allergies to gentamicin. * Patients less than 18 years old. * Off-pump cardiac surgery. * Minimal invasive cardiac surgery. * Elevated serum creatinine level. * Emergent cases * Harvesting of Bilateral internal thoracic artery.

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Conditions

The condition(s) this trial relates to.

Surgical Wound Infection

As listed by the trial registrant

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

Surgical site infection (SSI)

Contacts and locations

Locations

  • cardiothorathic surgery department -faculty of medecine-zagazig univeristy- Egypt

    Zagazig, Sharqia Province, 44519, Egypt

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Other studies related to the condition(s) this trial covers.