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New study tests antibiotic beads vs discs to save breast implants

NCT ID NCT07339215

Disease control Sponsor: University of California, Davis 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 types of antibiotic carriers placed during tissue expander breast reconstruction to lower infection risk. About 100 women will receive either absorbable antibiotic beads or a non-absorbable disc, both releasing vancomycin and tobramycin. Researchers will measure antibiotic levels in breast fluid and track infections and complications for 90 days. The goal is to find which method better prevents infections that can lead to pain, extra surgeries, or loss of the reconstruction.

What this could mean

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

Active substance
antibiotic-loaded calcium sulfate beads and polymethylmethacrylate antibiotic disc (both containing vancomycin and tobramycin)
What this could lead to
If one method works better, it could reduce infections, pain, and the need for extra surgeries after breast reconstruction.
What could go wrong
This is a small, early-stage study with only 100 patients. It compares two existing methods, so neither may prove clearly better. Results may not apply to all patients.

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 100 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

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.

Ages

18 years and older

Sex

Female participants only

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: 1. Adult females ≥18 years undergoing TE-based breast reconstruction (immediate or delayed). 2. Able to consent and comply with follow-up/aspiration visits. Exclusion Criteria: 1. Allergy to vancomycin, tobramycin, or PMMA components. 2. CKD stage 4-5 (eGFR \<30 mL/min/1.73m²). 3. Chronic immunosuppression (≥10 mg prednisone daily or biologic immunosuppressants). 4. Active systemic infection 5. Pregnancy, planning to become pregnant during the study, or lactation. 6. Lack of capacity to provide consent. 7. Prisoners

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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.

Tissue expander based breast reconstruction

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

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

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