Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Merisa Piper, MD (ucsf)

Description

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.

Official Title

Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction

Details

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.

Keywords

Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease, Post-Surgical Antibiotics, Breast Implant Infections, Breast Microbiome, Breast Reconstruction, Mastectomy, Infections, Breast Neoplasms, Disease Susceptibility, Cephalexin

Eligibility

You can join if…

Open to females ages 18 years and up

  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
  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.

You CAN'T join if...

  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

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UC Cancer

  • Merisa Piper, MD (ucsf)
    Assistant Professor, Surgery, School of Medicine. Authored (or co-authored) 45 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05020574
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated