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Can a gel stop infections after heart surgery? new study aims to find out

NCT ID NCT07275307

Prevention Sponsor: IRCCS Policlinico S. Donato 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study tests whether applying Prontosan Wound Gel X during heart surgery can reduce the chance of wound infections. About 456 adults having planned heart surgery will receive the gel, and researchers will track infection rates during their hospital stay. The goal is to see if this simple addition to surgery can improve recovery and shorten hospital stays.

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.

Participants

About 456 people

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

Started

Feb 2026

Expected to finish

Dec 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.

Who is studied

The study population consists of adult patients (≥18 years) undergoing elective cardiac surgery via median sternotomy at IRCCS Policlinico San Donato, a high-volume cardiovascular center performing over 1,000 adult cardiac surgeries annually. Eligible participants are consecutively enrolled and represent typical real-world cardiac surgery patients undergoing procedures such as coronary artery bypass grafting, valve repair or replacement, or aortic surgery. All participants receive the intraoperative application of Prontosan Wound Gel X as part of standard wound management. The population excludes patients undergoing urgent or emergency procedures, those with contraindications to the gel, or those enrolled in interventional trials.

Ages

18 years and older

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: * Scheduled for elective cardiac surgery requiring median sternotomy (e.g., CABG, valve surgery, aortic surgery) * Ability to provide informed consent * Independent clinical decision by the treating surgeon to apply Prontosan Wound Gel X during surgery, irrespective of study enrollment Exclusion Criteria: * Urgent or emergency surgery * Concurrent enrollment in interventional clinical trials * Known hypersensitivity to components of Prontosan Wound Gel X * Local skin conditions or infections at the planned incision site that preclude safe use of topical antiseptic products

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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 after major surgery

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

  • IRCCS Policlinico San Donato

    RECRUITING

    San Donato Milanese, Michigan, 20097, Italy

More trials for these conditions

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