Breast Cancer Clinical Trial
Microbiome and Association With Implant Infections
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 patients 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.
Full Description
PRIMARY OBJECTIVE:
a) To determine the feasibility of breast microbiome sampling using the study techniques
SECONDARY OBJECTIVES:
To define the differences in the gut and breast microbiomes between patients undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not.
To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction.
Patients are followed-up for 90 days after undergoing implant-based reconstruction.
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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
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There is 1 Location for this study
San Francisco California, 94143, United States More Info
Principal Investigator
Sub-Investigator
Sub-Investigator
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