Microbiome and Association With Implant Infections

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: Female

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 breast cancer patients undergoing reconstructive surgery with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: The Plastic Surgery Foundation
• Treatments: Cephalexin

Criteria

Inclusion Criteria:

1. Patients must have histologically confirmed breast malignancy

2. Age >= 18 years

3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders

4. Ability to understand a written informed consent document, and the willingness to sign it

5. At least 4 weeks post-completion of chemotherapy

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