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Microbiome and Association With Implant Infections

RecruitingPhase 2Ages 18 Years - anyFemaleUniversity of California, San Francisco
NCT05020574 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Cephalexin
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Where

1 site
University of California, San Francisco
San Francisco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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