Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
1 other identifier
interventional
19
1 country
1
Brief Summary
Breast implants, either cosmetic or reconstructive, are among the most common procedures performed by plastic surgeons. Bacterial infections or biofilms are implicated in the majority of breast implant complications including infection requiring explantation, capsular contracture (CC), and/or breast-implant associated anaplastic large cell lymphoma (BIA-ALCL). The research team, which has already extensively characterized bacterial pathogenesis in the urinary tract and designed non-antibiotic therapeutics to reduce the incidence of catheter-associated urinary tract infections (CAUTIs), and proposal will study bacteria-breast implant interactions and explore further the impact of the breast microbiome. The proposed research provides a greater understanding of which bacteria can colonize breast implants, their source, and how effective antibiotic pocket irrigation is at eliminating them, and begins to examine the mechanisms by which bacteria bind and colonize the implant surface. These insights will set the groundwork for developing new therapeutic agents that can disrupt the binding of certain bacteria to breast implants. Strategies that minimize problems bacteria can cause, while avoiding antibiotics, will reduce bacteria-related implant complications, limit antibiotic-related side effects, and reduce bacterial resistance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2018
CompletedFebruary 8, 2019
February 1, 2019
1.2 years
June 22, 2017
February 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of tissue expander(s) removed due to infection
The bulk of analyses will be to study bacterial biofilm formation on the explanted breast tissue, skin/scar, drain, acellular dermal matrix, tissue expander, and capsule.
Up to 1 year
Number of tissue expander(s) removed due to patient preference
Up to 1 year
Secondary Outcomes (4)
Duration of implantation
Up to 1 year
Duration the drain was in
Up to 1 year
Incidence of development of an infection or a wound
Up to 1 year
Incidence of capsular contracture
Up to 1 year
Study Arms (2)
Arm 1: Intraoperative pocket irrigation with NS
ACTIVE COMPARATOR* 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care saline pocket irrigation will receive 500 cc of normal saline alone per pocket.
Arm 2: Intraoperative pocket irrigation with NS + antibiotics
ACTIVE COMPARATOR* 1 gram cefazolin intravenous before surgical incision * Standard of care bilateral skin- or nipple-sparing mastectomies as determined by breast surgical oncologists * Immediate standard of care breast reconstruction with subpectoral tissue expanders and a 16 x 8 ADM sling * Standard of care antibiotic pocket irrigation will receive 500 cc of normal saline plus 1 gram cefazolin, 80 mg gentamicin, and 50,000 units bacitracin
Interventions
Intraoperative pocket irrigation with normal saline
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.
Standard of care
Standard of care
* Standard of care * Either breast implant or autologous flap
* Standard of care * Either breast implant or autologous flap
Standard of care
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
Eligibility Criteria
You may qualify if:
- Female
- Between 18 and 75 years of age, inclusive
- Undergoing bilateral mastectomy reconstruction with tissue expanders (ipsilateral therapeutic/contralateral prophylactic) planned to be exchanged for breast implants
- Able to understand and willing to sign an IRB-approved written informed consent document
You may not qualify if:
- Male
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terence M Myckatyn, M.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2017
First Posted
July 11, 2017
Study Start
July 25, 2017
Primary Completion
September 26, 2018
Study Completion
September 26, 2018
Last Updated
February 8, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share