drugset / Trial / NCT03213249

Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy

NCT03213249

RandomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

Start
2017-07-25
Primary completion
2018-09-26
Completion
2018-09-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bacitracin Unknown 50000 iu Other
Comparator Cefazolin Small molecule 1 g Intravenous
Comparator Gentamicin Small molecule 80 mg Other

Indications