Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Title: Study of gentamicin, vancomycin and cefazolin antibiotics to prevent infections in women having breast reconstruction surgery with implants

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on preventing infections in women who undergo breast reconstruction surgery with implants. The research evaluates the effectiveness of a combination of three antibiotics - gentamicin, vancomycin, and cefazolin - applied directly to the surgical area during breast reconstruction procedures. These medications are mixed with sodium chloride solution, which is commonly known as saline solution.

The main purpose of this research is to determine if using these antibiotics locally during surgery can reduce the risk of infection and prevent complications that might lead to implant removal. The study involves patients who are having breast reconstruction surgery with implants, whether the reconstruction is done immediately after breast removal or at a later time.

During the surgical procedure, some patients will receive the antibiotic solution treatment applied around the implant, while others will receive standard care. The study will monitor patients for six months after their surgery to track any complications or issues that might develop. This research aims to find better ways to protect patients from developing infections after breast reconstruction surgery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial breast reconstruction surgery

    During the surgery, the breast implant or expander will be treated with a special antibiotic solution containing gentamicin, vancomycin, and cefazolin

    The antibiotics will be applied directly to the implant surface before placement

    This procedure can be performed for immediate or delayed reconstructions, and for single or both breasts

  2. Step 2

    Post-surgery monitoring - first 180 days

    Your recovery will be monitored for the first 180 days (6 months) after surgery

    Medical staff will check for any signs of surgical site infection that might require antibiotic treatment

    The condition of the breast implant will be evaluated regularly

    Any need for additional procedures will be assessed, such as: revision surgery of the tissue capsule around the implant, or exchange of permanent implant to expander implant

  3. Step 3

    Extended monitoring period

    Monitoring will continue for up to one year after the surgery

    The medical team will continue to assess the condition of the implant

    Any complications or need for implant removal will be documented

  4. Step 4

    Final assessment

    A final evaluation will be conducted at the end of the one-year period

    The overall success of the breast reconstruction will be assessed

    The study will conclude with documentation of any complications or additional procedures that occurred during the monitoring period

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must be biologically female
  • Must provide signed informed consent showing agreement to participate in the study
  • Must be scheduled for breast reconstruction surgery using implants or tissue expanders. This includes:
    • Immediate reconstruction (performed at the same time as breast removal)
    • Delayed reconstruction (performed some time after breast removal)
    • Surgery on one breast (unilateral) or both breasts (bilateral)
    • Can include reconstruction with or without additional tissue flap (using patient's own tissue from another part of body)

Who cannot join the trial?

14 criteria

  • Known allergy or hypersensitivity to gentamicin, vancomycin, or cefazolin (these are the antibiotics used in the study)
  • Active infection at the time of surgery
  • Pregnancy or breastfeeding
  • History of previous breast reconstruction surgery with complications
  • Severe immune system disorders (conditions that weaken the body's ability to fight infections)
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Chronic medical conditions that are not well controlled (such as diabetes or heart disease)
  • History of adverse reactions to breast implants
  • Previous radiation therapy to the chest area
  • Blood clotting disorders that could increase surgical risks
  • Mental health conditions that might interfere with following study procedures
  • Inability to attend follow-up appointments
  • Systemic antibiotic treatment (antibiotics that affect the whole body) within 2 weeks before surgery
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Gentamicin is an antibiotic medication used to prevent bacterial infections. In this trial, it is applied locally to the breast implant area during reconstructive surgery to help reduce the risk of post-surgical infections. Vancomycin is a powerful antibiotic that fights serious bacterial infections. In this study, it is used as part of a combination treatment applied directly to breast implants during reconstruction surgery to prevent infection complications. Cefazolin is an antibiotic commonly used to prevent infections during and after surgery. In this trial, it is combined with other antibiotics and applied directly to breast implants during reconstructive surgery to help protect against bacterial infections that could lead to implant loss. The three antibiotics are used together as a prophylactic (preventive) solution that is applied directly to breast implants during reconstructive surgery to reduce the risk of infection and implant loss.

What is already known about the treatment

  • Gentamicin

    An aminoglycoside antibiotic administered through local application during breast implant surgery to prevent infection. This medication works by binding to bacterial ribosomes and blocking protein synthesis, effectively killing bacteria. It is particularly effective against gram-negative organisms and is commonly used in surgical prophylaxis to reduce the risk of postoperative infections.

  • Vancomycin

    A glycopeptide antibiotic applied locally during breast implant procedures to prevent bacterial colonization. It functions by interfering with cell wall synthesis in bacteria, particularly effective against gram-positive organisms including resistant strains like MRSA. This medication is widely recognized in surgical prophylaxis and is often used in combination with other antibiotics for enhanced coverage.

  • Cefazolin

    A first-generation cephalosporin antibiotic used locally during breast reconstruction surgery as a prophylactic agent. It works by disrupting bacterial cell wall synthesis and provides broad-spectrum coverage against many common surgical pathogens. This medication is considered a standard choice for surgical prophylaxis due to its proven safety profile and effectiveness against both gram-positive and gram-negative bacteria.

Investigated diseases

  • Surgical Site Infection

    A condition that develops in or around the surgical wound following a surgical procedure. It typically occurs within days to weeks after surgery and is characterized by redness, swelling, warmth, and pain around the incision site. The infection can affect different layers of tissue, from superficial skin to deeper structures. It may be accompanied by fever and drainage from the wound site.

  • Post-surgical Implant Infection

    A complication that occurs when bacteria colonize the area around a surgical implant. The infection can develop shortly after implant placement or months later, causing localized inflammation and discomfort around the implant site. The condition may lead to the formation of a biofilm on the implant surface. Symptoms typically include persistent pain, swelling, and warmth in the affected area.

  • Capsular Contracture

    A condition where scar tissue forms around a breast implant, creating a hard, constricting capsule. The tissue gradually tightens and squeezes the implant, potentially changing its shape and position. This process can occur gradually over time following breast implant surgery. The condition can cause the breast to feel firm or hard to the touch and may create visible distortion of the breast shape.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517672-38-00Protocol codeBREAST-AB-01Estimated enrolment1 003 patientsSponsorRigshospitalet

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).