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Microbiome and Association With Implant Infections

Primary Purpose

Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cephalexin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Post-Surgical Antibiotics, Breast Implant Infections, Breast Microbiome, Breast Reconstruction, Mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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
  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

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cohort A: Standard antibiotics

Cohort B: No antibiotics

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
August 20, 2021
Last Updated
November 14, 2022
Sponsor
University of California, San Francisco
Collaborators
The Plastic Surgery Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05020574
Brief Title
Microbiome and Association With Implant Infections
Official Title
Microbiome and Association With Implant Infections: Investigating the Impact of Antibiotics on the Gut and Breast Microbiomes Post-mastectomy With Implant-based Breast Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
The Plastic Surgery Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Female, Genetic Predisposition to Disease
Keywords
Post-Surgical Antibiotics, Breast Implant Infections, Breast Microbiome, Breast Reconstruction, Mastectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: Standard antibiotics
Arm Type
Experimental
Arm Description
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - Prescribed standard postoperative antibiotics to take for at least 7 days post-operatively
Arm Title
Cohort B: No antibiotics
Arm Type
No Intervention
Arm Description
Receive standard pre-incision antibiotics and 24-hour perioperative antibiotics - No antibiotics post-operatively, unless patient develops clinical evidence of infection
Intervention Type
Drug
Intervention Name(s)
Cephalexin
Other Intervention Name(s)
Keflex
Intervention Description
Given orally (PO)
Primary Outcome Measure Information:
Title
Proportion of tissue samples obtained successfully over time
Description
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 days
Title
Proportion of aspirate samples obtained successfully overall
Description
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 days
Title
Proportion of tissue samples successfully producing microbiome data
Description
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 days
Title
Proportion of aspirate samples successfully producing microbiome data
Description
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 days
Title
Proportion of any samples successfully producing microbiome data
Description
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.
Time Frame
90 days
Title
Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only)
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Proportion of participants with post-operative infection
Description
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 days
Title
Shannon Diversity Index Score for species of microbiome
Description
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 days
Title
Number of overall identified microbes
Description
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 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Barnes, MD
Phone
(415) 502-1259
Email
Laura.Barnes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merisa Piper, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Barnes, MD
Phone
415-502-1259
Email
Laura.Barnes@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Merisa Piper, MD
First Name & Middle Initial & Last Name & Degree
Laura Barnes, MD
First Name & Middle Initial & Last Name & Degree
Michael Campbell, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Microbiome and Association With Implant Infections

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