RecruitingPhase 2NCT05020574

Microbiome and Association With Implant Infections

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

Sponsor

University of California, San Francisco

Enrollment

200 participants

Start Date

Sep 28, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Female Genetic Predisposition to Disease

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether the bacteria living on the skin (the microbiome) are linked to infections around breast implants after mastectomy surgery. The goal is to understand why some patients develop implant infections while others do not. **You may be eligible if...** - You have been diagnosed with breast cancer or carry a genetic mutation that increases your risk of breast cancer - You are 18 or older - You are scheduled for mastectomy with immediate placement of tissue expanders or breast implants - You completed chemotherapy or radiation therapy at least 4 weeks before surgery **You may NOT be eligible if...** - You have significant medical conditions or lab abnormalities that make participation unsafe - You recently completed chemotherapy or radiation (less than 4 weeks ago) - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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