Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Mammoplasty Clinical Trial

Official title:

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213249
• Other study ID #: 201704134
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2017
• Est. completion date: September 26, 2018

Study information

• Verified date: February 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 26, 2018
• Est. primary completion date: September 26, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Implant Infection
• Mammoplasty

Intervention

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.
• Bilateral skin- or nipple-sparing mastectomies
Standard of care

Device:
• Tissue expander
Standard of care
• 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
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	The Plastic Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of tissue expander(s) removed due to patient preference		Up to 1 year
Secondary	Duration of implantation		Up to 1 year
Secondary	Duration the drain was in		Up to 1 year
Secondary	Incidence of development of an infection or a wound		Up to 1 year
Secondary	Incidence of capsular contracture		Up to 1 year

External Links

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