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NCT03213249 · ClinicalTrials.gov registry record · Phase 1
Bacterial Biofilms in Reconstructive Breast Prostheses Following Mastectomy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03213249 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 19 participants.
The verdict
NCT03213249, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cefazolin
- DEVICE Tissue expander
- OTHER Normal saline
- PROCEDURE Skin biopsy
- PROCEDURE Bilateral skin- or nipple-sparing mastectomies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2017-07-25 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03213249
The ClinicalTrials.gov registry entry for NCT03213249 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cefazolin is the first listed.
NCT03213249 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03213249 about?
NCT03213249 is a clinical study titled "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...
What is the current status of trial NCT03213249?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2017-07-25. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT03213249?
The interventions under investigation include: Cefazolin (DRUG), Tissue expander (DEVICE), Normal saline (OTHER), Skin biopsy (PROCEDURE), Bilateral skin- or nipple-sparing mastectomies (PROCEDURE).
Who is sponsoring clinical trial NCT03213249?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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