Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

The Washington University

Status and phase: Completed; Phase 1

Conditions: Breast Implant Infection; Mammoplasty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03213249

201704134

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Arm 1: Intraoperative pocket irrigation with NS

Active Comparator group

Description:

* 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.

Treatment:

Device: Tissue expander

Procedure: Skin biopsy

Procedure: Bilateral skin- or nipple-sparing mastectomies

Other: Acellular dermal matrix sling

Procedure: Autologous flap

Other: Normal saline

Device: Breast implant

Arm 2: Intraoperative pocket irrigation with NS + antibiotics

Active Comparator group

Description:

* 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

Treatment:

Device: Tissue expander

Procedure: Skin biopsy

Procedure: Bilateral skin- or nipple-sparing mastectomies

Other: Acellular dermal matrix sling

Procedure: Autologous flap

Drug: Gentamicin

Other: Normal saline

Drug: Bacitracin

Drug: Cefazolin

Device: Breast implant