Microbiome and Association With Implant Infections
Recruiting now · Phase 2
Conditions studied: Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease
In brief
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.
Key facts
- Study ID
- NCT05020574
- Run by
- University of California, San Francisco
- People needed
- 200
- Starts
- 2021-09-28
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
- Age >= 18 years
- Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
- Ability to understand a written informed consent document, and the willingness to sign it
- At least 4 weeks post-completion of chemotherapy or radiation therapy.
You may not qualify if…
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Pregnant or breastfeeding
- Patients who have taken antibiotics within 90 days of the consent date
- Patients who have taken probiotics within 90 days of the consent date
- Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
- Male patients
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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