Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Study Overview
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Brief Summary
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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.

Official Title
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Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Conditions
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Breast Implant Infection, Mammoplasty

Intervention / Treatment
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* Other: Normal saline
* Drug: Cefazolin
* Procedure: Skin biopsy
* Procedure: Bilateral skin- or nipple-sparing mastectomies
* Device: Tissue expander
* Device: Breast implant
* Procedure: Autologous flap
* Other: Acellular dermal matrix sling
* Drug: Gentamicin
* Drug: Bacitracin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Intraoperative pocket irrigation with NS<br>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. | Other: Normal saline<br>* Intraoperative pocket irrigation with normal saline<br>* Other names: NS;Procedure: Skin biopsy<br>* Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.<br>Procedure: Bilateral skin- or nipple-sparing mastectomies<br>* Standard of care<br>Device: Tissue expander<br>* Standard of care<br>Device: Breast implant<br>* Standard of care Either breast implant or autologous flap<br>Procedure: Autologous flap<br>* Standard of care Either breast implant or autologous flap<br>Other: Acellular dermal matrix sling<br>* Standard of care<br>|
| Active Comparator: Arm 2: Intraoperative pocket irrigation with NS + antibiotics<br>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 | Other: Normal saline<br>* Intraoperative pocket irrigation with normal saline<br>* Other names: NS;Drug: Cefazolin<br>* 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<br>* Other names: Ancef;Procedure: Skin biopsy<br>* Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.<br>Procedure: Bilateral skin- or nipple-sparing mastectomies<br>* Standard of care<br>Device: Tissue expander<br>* Standard of care<br>Device: Breast implant<br>* Standard of care Either breast implant or autologous flap<br>Procedure: Autologous flap<br>* Standard of care Either breast implant or autologous flap<br>Other: Acellular dermal matrix sling<br>* Standard of care<br>Drug: Gentamicin<br>* 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<br>* Other names: Garamycin;Drug: Bacitracin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |