Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microbiome and Association With Implant Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05020574
Recruitment Status : Not yet recruiting
First Posted : August 25, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
The Plastic Surgery Foundation
Information provided by (Responsible Party):
University of California, San Francisco

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 breast cancer patients undergoing reconstructive surgery with high initial abundance of Staphylococcus and/or Pseudomonas are more likely to develop subsequent tissue expander-related infections from these respective organisms.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Female Drug: Cephalexin Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

a) To determine the feasibility of breast microbiome sampling using the study techniques

SECONDARY OBJECTIVES:

  1. To define the differences in the gut and breast microbiomes between patients undergoing mastectomy with implant-based reconstruction who develop post-operative implant infection and those who do not.
  2. To determine the effects of post-operative antibiotics on the gut and breast microbiomes after mastectomy with implant-based reconstruction.

Patients are followed-up for 90 days after undergoing implant-based reconstruction.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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
Drug: Cephalexin
Given orally (PO)
Other Name: Keflex

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



Primary Outcome Measures :
  1. Proportion of tissue samples obtained successfully over time [ Time Frame: 90 days ]
    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.

  2. Proportion of aspirate samples obtained successfully overall [ Time Frame: 90 days ]
    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.

  3. Proportion of tissue samples successfully producing microbiome data [ Time Frame: 90 days ]
    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.

  4. Proportion of aspirate samples successfully producing microbiome data [ Time Frame: 90 days ]
    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.

  5. Proportion of any samples successfully producing microbiome data [ Time Frame: 90 days ]
    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.

  6. Correlation of the change in breast microbiome over time with total duration of antibiotics (Cohort A only) [ Time Frame: 90 days ]

    We 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 :
  1. Proportion of participants with post-operative infection [ Time Frame: 90 days ]
    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.

  2. Shanon Index Score for species of microbiome [ Time Frame: 90 days ]
    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.

  3. Number of overall identified microbes [ Time Frame: 90 days ]
    We will evaluate microbial composition by grouping identified microbes into operational taxonomic units at the species, genera and phyla levels. We will compare the relative abundances of these microbes between groups at the species, gene



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have histologically confirmed breast malignancy
  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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05020574


Contacts
Layout table for location contacts
Contact: Laura Barnes, MD (415) 502-1259 Laura.Barnes@ucsf.edu

Locations
Layout table for location information
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Contact: Laura Barnes, MD    415-502-1259    Laura.Barnes@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Merisa Piper, MD         
Sub-Investigator: Laura Barnes, MD         
Sub-Investigator: Michael Campbell, PhD         
Sponsors and Collaborators
University of California, San Francisco
The Plastic Surgery Foundation
Investigators
Layout table for investigator information
Principal Investigator: Merisa Piper, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05020574    
Other Study ID Numbers: 217510
NCI-2021-08985 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University of California, San Francisco:
Post-Surgical Antibiotics
Breast Implant Infections
Breast Microbiome
Breast Reconstruction
Mastectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents