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

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What is this study about?

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 antibioticsgentamicin, 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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Aalborg University Hospital Aalborg Denmark
Rigshospitalet Copenhagen Denmark
Hxsyja Hhajsvzp Herlev Denmark
Ankkyc Uyuxoxfhsn Hfsbvmpg Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
15.01.2021

Trial locations

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.

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 ID:
2024-517672-38-00
Protocol code:
BREAST-AB-01
NCT ID:
NCT04731025
Trial Phase:
Therapeutic confirmatory (Phase III)

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