Microbiome and Implant Infections in Breast Cancer Patients
This study is looking at the connection between the body's natural bacteria (microbiome) and infections that can happen after breast cancer surgery with implants. Researchers want to see if certain bacteria, like Staphylococcus and Pseudomonas, increase the chance of infection. You might be able to join if you are a woman, at least 18 years old, have breast cancer or a high risk for it, and are having a mastectomy (breast removal surgery) with immediate implant placement. The study will test how well they can collect samples for microbiome analysis. You will either receive the antibiotic Cephalexin after surgery or no antibiotics unless an infection occurs. The study is currently unclear on its recruitment status and plans to enroll 200 participants.
- Study design
- This is an interventional study that plans to enroll 200 participants. Participants will be randomly assigned to one of two groups.
- What's involved
- Participants will be followed for 90 days. You will provide samples and may receive antibiotics after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed up for 90 days after their surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Microbiome and Association With Implant Infections
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Merisa Piper, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Proportion of tissue samples obtained successfully over time90 days
The feasibility of success in obtaining samples from breast tissue will be measured as a binary outcome (successful or not successful) over time (intra-operatively, week 1, week 2, week 3, and week 4). The investigators will assess and document success in obtaining a tissue sample immediately at the time of sampling of each participant.
- Proportion of aspirate samples obtained successfully overall90 days
The feasibility of success in obtaining samples from the tissue expander aspiration ports will be measured as a binary outcome (successful or not successful) over time (intra-operatively, week 1, week 2, week 3, and week 4). The investigators will assess and document success in obtaining a aspirate sample immediately at the time of sampling of each participant.
- Proportion of tissue samples successfully producing microbiome data90 days
Feasibility based off of the success rates in producing microbiome data from tissue samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
- Proportion of aspirate samples successfully producing microbiome data90 days
Feasibility based off of the success rates in producing microbiome data from tissue samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
- Proportion of any samples successfully producing microbiome data90 days
Feasibility based off of the success rates in producing microbiome data from tissue or aspirate samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.
- Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)90 days
The investigators will analyze the microbiomes between groups, between microbiome environments (gut v. breast, inter-individual). The correlate of change in breast microbiome over time will be compared to the total duration of antibiotics for Cohort A only. The measure of association ranges from +1 to -1, with a value of zero equal to no association.