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Antibiotic wash for breast implants could cut surgery failures

NCT ID NCT04731025

Prevention Sponsor: Mikkel Herly 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Updated 2 times

Summary

This study tests whether rinsing breast implants with a mix of three antibiotics before placing them can reduce the chance of the implant being removed later. About 1,000 women having breast reconstruction after cancer will be randomly assigned to get the antibiotic rinse or a placebo. The goal is to see if this simple step can prevent infections and other problems that lead to implant loss.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,003 people

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

Started

Jan 2021

Expected to finish

Sep 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 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Age ≥ 18 years * Biologically female * Signed informed consent * Scheduled for breast reconstruction with implants or expanders including: 1. Immediate or delayed reconstructions 2. Bilateral or unilateral reconstructions 3. With or without simultaneous flap reconstruction Exclusion Criteria: * Pregnancy * Breast feeding * Known allergy towards Vancomycin, Gentamicin and Cefazolin * Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides * Known allergy towards neomycin * Known impaired renal function with GFR \< 60 mL/min * Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity * Myasthenia Gravis

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Conditions

The condition(s) this trial relates to.

Implant Capsular Contracture prosthesis-related infectious disease

As listed by the trial registrant

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

Antibiotic side effect Implant capsular contracture Implant complication Implant expulsion Implant infection Implant site infection Implant site pocket infection

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus University Hospital

    Aarhus, 8000, Denmark

  • Herlev and Gentofte Hospital

    Herlev, 2730, Denmark

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • South-West Jutland Hospital

    Esbjerg, 6700, Denmark

  • Vejle Hospital

    Vejle, 7100, Denmark

  • Zealand University Hospital

    Roskilde, 4000, Denmark

More trials for these conditions

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