Microbiome and Association With Implant Infections

NCT ID: NCT05020574

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cephalexin

Intervention Type: DRUG

Given orally (PO)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cephalexin

Given orally (PO)

Intervention Type: DRUG

Other Intervention Names

Keflex

Eligibility Criteria

Inclusion Criteria

1. Patients must have histologically confirmed breast malignancy OR genetic predisposition to breast cancer.

2. Age >= 18 years

3. Scheduled to undergo mastectomy with the immediate placement of tissue expanders or implant placement

4. Ability to understand a written informed consent document, and the willingness to sign it

5. At least 4 weeks post-completion of chemotherapy or radiation therapy.

Exclusion Criteria

1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study

2. Pregnant or breastfeeding

3. Patients who have taken antibiotics within 90 days of the consent date

4. Patients who have taken probiotics within 90 days of the consent date

5. Patients who have a documented or reported allergic reaction to the outlined antibiotics to be used in this study

6. Male patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Plastic Surgery Foundation

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merisa Piper, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura Barnes, MD

Role: CONTACT

Laura.Barnes@ucsf.edu

(415) 502-1259

Facility Contacts

Laura Barnes, MD

Role: primary

Laura.Barnes@ucsf.edu

415-502-1259

Role: backup

cancertrials@ucsf.edu

877-827-3222

Other Identifiers

NCI-2021-08985

Identifier Type: REGISTRY

Identifier Source: secondary_id

217510

Identifier Type: -

Identifier Source: org_study_id