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Microbiome and Association With Implant Infections

RECRUITINGPhase 2Sponsored by University of California, San Francisco
Actively Recruiting
PhasePhase 2
SponsorUniversity of California, San Francisco
Started2021-09-28
Est. completion2026-12-31
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

Summary

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions4

Breast CancerBreast Cancer FemaleCancerGenetic Predisposition to Disease

Locations1 site

University of California, San Francisco
San Francisco, California, 94143
Laura Barnes, MD415-502-1259Laura.Barnes@ucsf.edu

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