Exploring the link between breast microbiome and implant infections after mastectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the relationship between the breast microbiome and the risk of implant-related infections in patients undergoing mastectomy with immediate reconstruction. Participants will be randomized into two groups: one receiving postoperative antibiotics and the other receiving no antibiotics unless an infection is clinically evident. The study aims to assess the feasibility of microbiome sampling and to compare the gut and breast microbiomes of those who develop infections versus those who do not. Follow-up will occur over a 90-day period to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
2. Age \>= 18 years
3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
4. Ability to understand a written informed consent document, and the willingness to sign it
5. At least 4 weeks post-completion of chemotherapy or radiation therapy.

Exclusion Criteria:

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
2. Pregnant or breastfeeding
3. Patients who have taken antibiotics within 90 days of the consent date
4. Patients who have taken probiotics within 90 days of the consent date
5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
6. Male patients

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Merisa Piper, MD — University of California, San Francisco
• Study coordinator: Laura Barnes, MD
• Email: Laura.Barnes@ucsf.edu
• Phone: (415) 502-1259

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.