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Microbiome and Association With Implant Infections
Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
The most common tissue expander-related infections are from Staphylococcus and Pseudomonas species. In addition, from breast tissue microbiome studies, Staphylococcus and Pseudomonas show variable abundance across samples. The investigator hypothesizes that participants undergoing mastectomy with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.
What is being tested
- Cephalexin (drug)
Sponsor: University of California, San Francisco · Participants: 200 · Started: Sep 28, 2021
Contact the study team
- Laura Barnes, MD · Phone: (415) 502-1259
Official record on ClinicalTrials.gov — NCT05020574
Locations in the U.S.
| California | University of California, San Francisco, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.