Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

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

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

Sponsors & Collaborators

• The Plastic Surgery Foundation

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Terence M Myckatyn, M.D. · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-25

Primary Completion

2018-09-26

Completion

2018-09-26

FDA Drug

Yes

Countries

• United States

Study Locations