Breast Implant Infection, Mammoplasty
Conditions
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.
Interventions
OTHERNormal saline
Intraoperative pocket irrigation with normal saline
DRUGCefazolin
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
PROCEDURESkin biopsy
Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.
PROCEDUREBilateral skin- or nipple-sparing mastectomies
Standard of care
DEVICETissue expander
Standard of care
DEVICEBreast implant
* Standard of care * Either breast implant or autologous flap
PROCEDUREAutologous flap
* Standard of care * Either breast implant or autologous flap
OTHERAcellular dermal matrix sling
Standard of care
DRUGGentamicin
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
DRUGBacitracin
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
Sponsors
The Plastic Surgery Foundation
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Male
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of tissue expander(s) removed due to infection | Up to 1 year | 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. |
| Number of tissue expander(s) removed due to patient preference | Up to 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed