Microbiome and Association With Implant Infections
Recruiting · NCT05020574 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Francisco
View the official record on ClinicalTrials.gov →Interventions studied
Cephalexin
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.
- Age \>= 18 years
- Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement
- Ability to understand a written informed consent document, and the willingness to sign it
- At least 4 weeks post-completion of chemotherapy or radiation therapy.
Exclusion criteria
- Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Pregnant or breastfeeding
- Patients who have taken antibiotics within 90 days of the consent date
- Patients who have taken probiotics within 90 days of the consent date
- Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study
- Male patients
Where it is running
1 location listed across 1 US state.
- University of California, San Francisco - San Francisco, California, United States