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| Name | Class |
|---|---|
| The Plastic Surgery Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Intraoperative pocket irrigation with NS | Active Comparator |
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| Arm 2: Intraoperative pocket irrigation with NS + antibiotics | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Other | Intraoperative pocket irrigation with normal saline |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terence M Myckatyn, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Cefazolin | Drug | 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 |
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| Skin biopsy | Procedure | Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange. |
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| Bilateral skin- or nipple-sparing mastectomies | Procedure | Standard of care |
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| Tissue expander | Device | Standard of care |
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| Breast implant | Device |
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| Autologous flap | Procedure |
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| Acellular dermal matrix sling | Other | Standard of care |
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| Gentamicin | Drug | 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 |
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| Bacitracin | Drug | 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 |
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| Up to 1 year |
| Incidence of capsular contracture | Up to 1 year |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D002437 | Cefazolin |
| D015625 | Tissue Expansion Devices |
| D018427 | Breast Implants |
| D005839 | Gentamicins |
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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