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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Cephalexin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Laura Barnes, MD
Laura.Barnes@ucsf.edu
(415) 502-1259
Time Frame
Start Date: 2021-09-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 200
Treatments
Experimental: Cohort A: Standard antibiotics
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
No_intervention: Cohort B: No antibiotics
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: The Plastic Surgery Foundation

This content was sourced from clinicaltrials.gov