Microbiome and Association With Implant Infections

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Aug 20, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how certain bacteria in the breast tissue might be linked to infections that can happen after surgery for breast cancer. Researchers want to find out if women who have higher levels of specific bacteria, namely Staphylococcus and Pseudomonas, at the time of their mastectomy are more likely to develop infections when they receive tissue expanders or implants. This study is important because it could help doctors better understand and prevent infections in patients undergoing breast cancer surgery.

To be eligible for this trial, participants need to be women aged 18 or older who have been diagnosed with breast cancer or have a genetic risk for it. They must be scheduled to have a mastectomy and the immediate placement of tissue expanders or implants, and they should be at least four weeks past any chemotherapy or radiation treatment. Women who are pregnant, breastfeeding, or have taken certain medications recently may not be able to participate. If you join the study, you’ll be asked to provide consent and may undergo some testing related to your breast tissue bacteria. This research could lead to better care and outcomes for patients in the future.

Gender

FEMALE

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