Microbiome and Association With Implant Infections

NCT05020574 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 217510NCI-2021-08985
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast Cancer Female; Genetic Predisposition to Disease

Keywords

Post-Surgical Antibiotics; Breast Implant Infections; Breast Microbiome; Breast Reconstruction; Mastectomy

Outcome Measures

Primary Outcomes (6)

• 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.

  90 days

• 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.

  90 days

• 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.

  90 days

• 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.

  90 days

• Proportion of any samples successfully producing microbiome data

  Feasibility based off of the success rates in producing microbiome data from tissue or aspirate samples in each patient will be measured as a binary outcome (successful or not successful) and will be reported.

  90 days

• Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)

  The investigators will analyze the microbiomes between groups, between microbiome environments (gut v. breast, inter-individual). The correlate of change in breast microbiome over time will be compared to the total duration of antibiotics for Cohort A only. The measure of association ranges from +1 to -1, with a value of zero equal to no association.

  90 days

Secondary Outcomes (3)

• Proportion of participants with post-operative infection

  90 days

• Shannon Diversity Index Score for species of microbiome

  90 days

• Number of overall identified microbes

  90 days

Study Arms (2)

Cohort A: Standard antibiotics

EXPERIMENTAL

Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively

Drug: Cephalexin

Cohort B: No antibiotics

NO INTERVENTION

Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection

Interventions

Cephalexin DRUG

Given orally (PO)

Also known as: Keflex

Cohort A: Standard antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Plastic Surgery Foundation: collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Genetic Predisposition to Disease

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Merisa Piper, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Barnes, MD

CONTACT

(415) 502-1259; Laura.Barnes@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 25, 2021
• Study Start: September 28, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)