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NCT03126448 · ClinicalTrials.gov registry record · NA
BBOT: Bacterial Burden in Ortho Trauma Procedures
A NA study of Orthopaedic Trauma Infections, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 142
- Enrollment target
- 1
- Study location
NCT03126448: Completed NA study of Orthopaedic Trauma Infections, sponsored by University of Maryland, Baltimore.
NCT03126448 is a NA study of Orthopaedic Trauma Infections that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 142 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03126448, a NA study of Orthopaedic Trauma Infections, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 142 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research project is to improve understanding of the potential role of highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the current standard of care, microbiologic culture (growing bacteria from tissue specimens in the laboratory). In order to understand the validity of the highly sensitive tests, parameters of the test in different groups of patients must be established. This study is examining how two highly sensitive tests compare to each other and to the standard of care (microbiologic culture) in three groups of patients. Group 1 is clean broken bone surgery undergoing plate and screw fixation, intramedullary nailing fixation where the fracture site is accessible, or staged treatment of a broken bones initially treated by joint spanning external fixation device. Group 2 will include patients having a plate and screws removed without clinical evidence of infection. Group 3 will be patients undergoing an initial procedure for fracture nonunion.
Primary Outcome
The objective of this research is to see if highly sensitive bacterial assays are useful for determining whether fracture nonunions are infected
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Highly Sensitive Assays
Study Locations (1)
Maryland
- University of Maryland, Shock Trauma Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2015-12-21 |
| Est. Completion | 2018-08-15 |
| Phase | NA |
What the finished NCT03126448 record still lists
NCT03126448 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Orthopaedic Trauma Infections appearing as the primary indexed condition, and to 1 intervention - of which Highly Sensitive Assays is the first listed.
NCT03126448 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03126448 about?
NCT03126448 is a clinical study titled "BBOT: Bacterial Burden in Ortho Trauma Procedures". The purpose of this research project is to improve understanding of the potential role of highly sensitive bacterial tests in diagnosing infected non-healing fractures compared to the current standard of care, microbiologic culture (growing bacteria from tissue specimens in the laboratory). In orde...
What is the current status of trial NCT03126448?
This trial is currently completed. It is a NA study. The enrollment target is 142 participants. The study started on 2015-12-21. Estimated completion is 2018-08-15.
What conditions does trial NCT03126448 study?
This clinical trial studies the following conditions: Orthopaedic Trauma Infections.
What interventions are being tested in trial NCT03126448?
The interventions under investigation include: Highly Sensitive Assays (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03126448?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03126448 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03126448's enrollment target sits among peer trials
142 711th of 2000 higher than 1,289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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