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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cephalexin
DrugGiven orally (PO)
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Standard antibioticsExperimental treatment 1 intervention
Group B: Cohort B: No antibioticsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proportion of tissue samples obtained successfully over time
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.
Time frame
90 days2
Proportion of aspirate samples obtained successfully overall
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.
Time frame
90 days3
Proportion of tissue samples successfully producing microbiome data
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.
Time frame
90 days4
Proportion of aspirate samples successfully producing microbiome data
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.
Time frame
90 daysSecondary outcomes
1
Proportion of participants with post-operative infection
Safety will be assessed by clinically assessing for signs of post-operative infection in each patient at each clinic visit. A post-operative infection is defined by clinical assessment of findings of surgical site erythema, tenderness, edema, and/or purulent drainage +/- fever. Proportion of participants with clinically diagnosed infection will be reported for each group and final diagnosis for analyses will be binary; a participant will either have a post-operative infection in the 90 day post-operative period or not have a post-operative infection in the 90 day post-operative period.
Time frame
90 days2
Shannon Diversity Index Score for species of microbiome
Alpha diversity will be evaluated for species richness by number of operational taxonomic units and for evenness using the Shannon Index. The Shannon diversity index (H) is an index that is commonly used to characterize species diversity in a community and accounts for both abundance and evenness of the species present. The proportion of species (i) relative to the total number of species (pi) is calculated, and then multiplied by the natural logarithm of this proportion (lnpi). The resulting product is summed across species, and multiplied by -1. Shannon's equitability (EH) can be calculated by dividing H by Hmax (here Hmax = lnS). Equitability assumes a value between 0 and 1 with 1 being complete evenness and the overall index score is represented by a percentage of the species.
Time frame
90 days3
Number of overall identified microbes
The investigators will evaluate microbial composition by grouping identified microbes into operational taxonomic units at the species, genera and phyla levels and will compare the relative abundances of these microbes between groups at the species, gene
Time frame
90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
The Plastic Surgery Foundation
Collaborator
Source ClinicalTrials.gov