NCT05020574PHASE2Recruiting

Microbiome and Association With Implant Infections

University of California, San Francisco

Start Date

9/28/2021

Completion Date

12/31/2026

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.

Detailed Description

PRIMARY OBJECTIVE: I. To determine the feasibility of breast microbiome sampling using the study techniques SECONDARY OBJECTIVES: I. To define the differences in the gut and breast microbiomes between participants undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not. II. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction. OUTLINE: Participants are randomized to 1 of 2 cohorts. COHORT A: Participants receive postoperative antibiotics to take for at least 7 days post-operatively. COHORT B: Participants receive no antibiotics post-operatively in the absence of clinical evidence of infection. Participants are followed up for 90 days.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Cephalexin

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Conditions

Breast CancerBreast Cancer FemaleGenetic Predisposition to Disease

Locations

University of California, San Francisco

San Francisco, California 94143

United States