Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-09-26

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.

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Detailed Description

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Conditions

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Breast Implant Infection Mammoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm 1: Intraoperative pocket irrigation with NS

* 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.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type OTHER

Intraoperative pocket irrigation with normal saline

Skin biopsy

Intervention Type PROCEDURE

Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

Bilateral skin- or nipple-sparing mastectomies

Intervention Type PROCEDURE

Standard of care

Tissue expander

Intervention Type DEVICE

Standard of care

Breast implant

Intervention Type DEVICE

* Standard of care
* Either breast implant or autologous flap

Autologous flap

Intervention Type PROCEDURE

* Standard of care
* Either breast implant or autologous flap

Acellular dermal matrix sling

Intervention Type OTHER

Standard of care

Arm 2: Intraoperative pocket irrigation with NS + antibiotics

* 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

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type OTHER

Intraoperative pocket irrigation with normal saline

Cefazolin

Intervention Type 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

Skin biopsy

Intervention Type PROCEDURE

Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

Bilateral skin- or nipple-sparing mastectomies

Intervention Type PROCEDURE

Standard of care

Tissue expander

Intervention Type DEVICE

Standard of care

Breast implant

Intervention Type DEVICE

* Standard of care
* Either breast implant or autologous flap

Autologous flap

Intervention Type PROCEDURE

* Standard of care
* Either breast implant or autologous flap

Acellular dermal matrix sling

Intervention Type OTHER

Standard of care

Gentamicin

Intervention Type 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

Bacitracin

Intervention Type 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

Interventions

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Normal saline

Intraoperative pocket irrigation with normal saline

Intervention Type OTHER

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

Intervention Type DRUG

Skin biopsy

Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.

Intervention Type PROCEDURE

Bilateral skin- or nipple-sparing mastectomies

Standard of care

Intervention Type PROCEDURE

Tissue expander

Standard of care

Intervention Type DEVICE

Breast implant

* Standard of care
* Either breast implant or autologous flap

Intervention Type DEVICE

Autologous flap

* Standard of care
* Either breast implant or autologous flap

Intervention Type PROCEDURE

Acellular dermal matrix sling

Standard of care

Intervention Type OTHER

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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NS Ancef Garamycin

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