BBOT: Bacterial Burden in Ortho Trauma Procedures

Completed · Not applicable

Conditions studied: Orthopaedic Trauma Infections

In brief

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.

Key facts

Study ID

NCT03126448

Run by

University of Maryland, Baltimore

People needed

142

Starts

2015-12-21

Expected to finish

2018-08-15

Last updated by the study team

2020-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Closed fracture undergoing open reduction internal fixation, intramedullary nailing (IMN) where the fracture site is accessible, or staged treatment of a pilon or plateau that was initially treated by joint spanning external fixation.
• Plate and screw removal without clinical evidence of infection
• Index procedure for fracture nonunion

You may not qualify if…

• Index fracture surgery for an open fracture or intramedullary nailing with fracture site not accessible
• Hardware removal if fracture not already healed
• Index nonunion surgery being bone grafting of a 'critical' defect
• Pregnant females

Where it is running

• University of Maryland, Shock Trauma Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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