Microbiome and Association With Implant Infections
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cephalexin
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Francisco
Lead sponsor
The Plastic Surgery Foundation
Collaborator
Source ClinicalTrials.gov