Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

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.

Study Overview

• Status: Completed
• Conditions: Breast Implant Infection; Mammoplasty
• Intervention / Treatment: Other: Normal saline; Procedure: Skin biopsy; Procedure: Bilateral skin- or nipple-sparing mastectomies; Device: Tissue expander; Device: Breast implant; Procedure: Autologous flap; Other: Acellular dermal matrix sling; Drug: Cefazolin; Drug: Gentamicin; Drug: Bacitracin

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Normal saline; Intraoperative pocket irrigation with normal saline; Other Names: NS; 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
Active Comparator: 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	Other: Normal saline; Intraoperative pocket irrigation with normal saline; Other Names: NS; 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: 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; Other Names: Ancef; 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; Other Names: Garamycin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Up to 1 year
Incidence of capsular contracture	Up to 1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: The Plastic Surgery Foundation

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): September 26, 2018
• Study Completion (Actual): September 26, 2018

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins; Cefazolin; Bacitracin
• Other Study ID Numbers: 201704134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No