Prophylactic treatment of breast implants with a solution of gentamicin, vancomycin and cefazolin antibiotics for women undergoing breast reconstructive surgery: a randomized controlled trial (The BREAST-AB trial)
Breast reconstruction surgery can help women rebuild their shape after breast cancer or other conditions. However, infections around implants can cause pain and sometimes mean the implant has to be removed completely. The BREAST-AB trial is testing a new way to protect implants during surgery. Surgeons will rinse the implant in either a salt-water wash containing three strong antibiotics (gentamicin, vancomycin, and cefazolin) or a standard salt-water wash alone. The aim is to find out if the antibiotic rinse reduces deep infections, prevents the need for extra corrective operations, and stops implants from having to be removed in the first six months to a year after surgery. This could make reconstructive surgery safer for future patients.
At a glance
What is this study about?
Having breast reconstruction surgery using implants is a major step for many women, particularly after treatment for breast cancer. While these operations are usually very successful, an infection around the new implant can be a difficult complication. If a deep infection develops, antibiotics given by mouth or drip may not always clear it, and surgeons sometimes have to remove the implant entirely to let the body heal.
In this study, called the BREAST-AB trial, researchers are testing whether washing the implant with a liquid mix of three different antibiotics just before putting it into the body makes a difference. The antibiotics used are gentamicin, vancomycin, and cefazolin. By coating the implant with these medicines during the operation, doctors hope to stop bacteria from sticking to the surface and causing trouble later on.
Women taking part will be put into one of two groups by chance. One group will have their implant rinsed with the antibiotic liquid, while the other group will have the standard salt-water wash. The surgical team will then closely monitor both groups over the following year to see whether the antibiotic rinse successfully reduces infections, lowers the need for repeat operations, and helps women keep their implants safely.
Key takeaways
- The BREAST-AB trial tests whether washing breast implants in three antibiotics prevents infections.
- It aims to reduce the need for repeat surgery or implant removal within 6 to 12 months.
- Participation happens during your planned breast reconstruction surgery under anaesthetic.
- A computer decides by chance whether your implant gets the antibiotic rinse or standard salt water.
- Joining is entirely voluntary and will not affect the quality of your ongoing NHS care.
Who may be eligible?
This trial is open to adult women aged 18 and older who are scheduled to have breast reconstruction surgery using an implant. This may be an immediate reconstruction done at the same time as a mastectomy, or a planned operation done later.
Because this is a study looking specifically at breast implants, it is only suitable for women having implant-based reconstruction. You might not be able to take part if you have known allergies to any of the antibiotics being tested, such as gentamicin, vancomycin, or cefazolin, or if you have certain existing medical conditions that make these medicines unsuitable for you.
Your surgical team will check your full medical history and planned procedure to confirm whether you can safely join the study. Taking part is completely voluntary.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a woman aged 18 or older.
- I am scheduled to have breast reconstructive surgery using an implant.
- I do not have a known allergy to gentamicin, vancomycin, or cefazolin.
- I am able to attend routine follow-up visits over the next 12 months.
What does participation involve?
If you decide to take part, the main difference will happen quietly during your planned reconstruction surgery. While you are asleep under general anaesthetic, your surgeon will rinse your breast implant in either the antibiotic wash or a standard salt-water wash. A computer chooses which wash is used at random, and neither you nor your care team will usually know which one you received.
After your operation, your recovery will follow standard NHS hospital care. You will attend your regular follow-up clinic appointments so doctors can check how your wounds are healing and look out for any signs of swelling, redness, or infection.
The study team will track your progress for up to one year. In particular, they will check how you are doing at 180 days (about six months) and at 12 months after surgery to see if you have needed any antibiotics or extra operations. You will not need to take any new medicines at home purely for the study.
Potential risks and benefits
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Common questions
Will I know if my implant was washed with antibiotics?
No. To keep the test fair, the treatment is chosen by chance by a computer, and both you and your doctors will not know which wash was used until the study finishes.
Will taking part change my operation date?
No, taking part will not delay your surgery. The trial takes place during your already scheduled breast reconstruction operation.
What happens if I get an infection after surgery?
You will receive immediate, standard medical care just like any other patient. This may include antibiotics or further surgery if needed to keep you safe.
Do I have to take extra tablets at home?
No. The trial medicines are used only as a wash in the operating theatre. You will only take medicines at home that your doctor normally prescribes for your recovery.
Can I leave the study if I change my mind?
Yes, you can step down from the study at any time. Doing so will not change your relationship with your surgical team or affect your future NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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