Clinical trial NCT05020574: Microbiome and Association With Implant Infections
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Breast Cancer Female
Genetic Predisposition to Disease
Keywords: Post-Surgical Antibiotics
Breast Implant Infections
Breast Microbiome
Breast Reconstruction
Mastectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: The Plastic Surgery Foundation
First posted: 2021-08-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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: 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

Primary outcomes:
measure: Proportion of tissue samples obtained successfully over time
timeFrame: 90 days
measure: Proportion of aspirate samples obtained successfully overall
timeFrame: 90 days
measure: Proportion of tissue samples successfully producing microbiome data
timeFrame: 90 days
measure: Proportion of aspirate samples successfully producing microbiome data
timeFrame: 90 days
measure: Proportion of any samples successfully producing microbiome data
timeFrame: 90 days
measure: Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of participants with post-operative infection
timeFrame: 90 days
measure: Shannon Diversity Index Score for species of microbiome
timeFrame: 90 days
measure: Number of overall identified microbes
timeFrame: 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Merisa Piper, MD
role: PRINCIPAL_INVESTIGATOR
References: