NCT05020574

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine the feasibility of breast microbiome sampling using the study techniques SECONDARY OBJECTIVES: I. To define the differences in the gut and breast microbiomes between participants undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not. II. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction. OUTLINE: Participants are randomized to 1 of 2 cohorts. COHORT A: Participants receive postoperative antibiotics to take for at least 7 days post-operatively. COHORT B: Participants receive no antibiotics post-operatively in the absence of clinical evidence of infection. Participants are followed up for 90 days.

Conditions

• Breast Cancer
• Breast Cancer Female
• Genetic Predisposition to Disease

Interventions

Type	Name	Description
DRUG	Cephalexin	Given orally (PO)

Timeline

• Start date: 2021-09-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-08-25
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study