NCT03213249

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Implant Infection
• Mammoplasty

Interventions

Type	Name	Description
OTHER	Normal saline	Intraoperative pocket irrigation with normal saline
DRUG	Cefazolin	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
PROCEDURE	Skin biopsy	Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.
PROCEDURE	Bilateral skin- or nipple-sparing mastectomies	Standard of care
DEVICE	Tissue expander	Standard of care
DEVICE	Breast implant	* Standard of care * Either breast implant or autologous flap
PROCEDURE	Autologous flap	* Standard of care * Either breast implant or autologous flap
OTHER	Acellular dermal matrix sling	Standard of care
DRUG	Gentamicin	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
DRUG	Bacitracin	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

Timeline

• Start date: 2017-07-25
• Primary completion: 2018-09-26
• Completion: 2018-09-26
• First posted: 2017-07-11
• Last updated: 2019-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study