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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 is a NA study of Orthopaedic Trauma Infections that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 142 participants. The trial reports 1 study location across 1 state.

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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.

Interventions

  • DIAGNOSTIC_TEST Highly Sensitive Assays

Study Locations (1)

Maryland

  • University of Maryland, Shock Trauma Center - Baltimore

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2015-12-21
Est. Completion 2018-08-15
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

What the Registry Record Tells You About NCT03126448

The ClinicalTrials.gov registry entry for NCT03126448 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.