N/A
N=142
BBOT: Bacterial Burden in Ortho Trauma Procedures
Orthopaedic Trauma Infections
Bottom Line
View on ClinicalTrials.gov: NCT03126448 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays — 10; 24; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Highly Sensitive Assays (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tissue Samples Identified With Bacterial DNA According to Highly Sensitive Bacterial Assays |
10; 24; 20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03126448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.