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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: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT03213249 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT03213249 record still lists
NCT03213249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which Cefazolin is the first listed.
NCT03213249 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03213249's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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