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OpenTrials
Completed

NCT Number: NCT03213249

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline

Other

Intraoperative pocket irrigation with normal saline

Other names: NS

Cefazolin

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

Other names: Ancef

skin biopsy

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

Procedure

Standard of care

Tissue expander

Device

Standard of care

Breast implant

Device
  • Standard of care
  • Either breast implant or autologous flap

Autologous flap

Procedure
  • Standard of care
  • Either breast implant or autologous flap

Acellular dermal matrix sling

Other

Standard of care

Gentamicin

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

Other names: Garamycin

Bacitracin

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

Primary outcomes

  1. Number of tissue expander(s) removed due to infection

    Time frame: Up to 1 year

    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.

  2. Number of tissue expander(s) removed due to patient preference

    Time frame: Up to 1 year

Secondary outcomes

  1. Duration of implantation

    Time frame: Up to 1 year

  2. Duration the drain was in

    Time frame: Up to 1 year

  3. Incidence of development of an infection or a wound

    Time frame: Up to 1 year

  4. Incidence of capsular contracture

    Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • The Plastic Surgery Foundation

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2017
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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