BBOT: Bacterial Burden in Ortho Trauma Procedures
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | December 21, 2015 |
| End Date: | August 15, 2018 |
Prospective Evaluation of Bacterial Burden in Orthopaedic Trauma Procedures Using Highly Sensitive Assays
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.
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.
Infected, broken bones that do not heal are a difficult clinical problem that significantly
affect patient quality of life. Current methodology for detecting bacteria (growth in
laboratory cultures) is inadequate to detect infections caused by bacteria existing in a
biofilm, which is the layer of "slime" found in the presence of foreign bodies (eg, implanted
metal devices to fix broken bones). Advances in molecular biology have allowed development of
highly sensitive tests to detect bacteria in the biofilm state. However, the limited prior
research has not included control groups or compared the performance of different highly
sensitive tests. To address these limitations and further define the role of highly sensitive
bacterial tests in clinical practice, the investigators hypothesize that there will be
increasing bacterial burden when comparing clean broken bone surgery (1st surgery) to
implanted metal device removal (2nd surgery, bone healed) to index nonunion surgery
(subsequent surgery, bone not healed) as measured by percentage of cases being positive for
bacteria using highly sensitive bacterial tests. Further, the highly sensitive bacterial
tests (Illumina MiSeq system and Ibis T5000 biosensor) will have similar ability to quantify
the number of bacteria and differentiate bacterial species. Eligible patients will consist of
three groups. 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. Tissue
obtained at the time of surgery will be sent to the research laboratory for culture and
performance of the two highly sensitive tests. The tissue samples taken will be tissue
normally removed and discarded in the course of these particular procedures. The rates of
positivity for culture and the highly sensitive tests will be compared amongst the three
groups. Investigators will also compare bacterial count and the distribution of bacterial
species found using the two highly sensitive tests. These data will then undergo statistical
analysis against clinical data gathered from review of the patients' charts. The overall
project goal is to establish the clinical relevance of highly sensitive bacterial tests in
diagnosing infected nonunions. The ability to more accurately identify patients with
infection may lead to a change in clinical decision making with respect to surgical procedure
or antibiotic treatment. This project will develop an improved understanding of the potential
role of highly sensitive bacterial tests in diagnosing infected nonunions compared to the
current standard of care, which is growing bacteria in the laboratory under artificial
conditions.
affect patient quality of life. Current methodology for detecting bacteria (growth in
laboratory cultures) is inadequate to detect infections caused by bacteria existing in a
biofilm, which is the layer of "slime" found in the presence of foreign bodies (eg, implanted
metal devices to fix broken bones). Advances in molecular biology have allowed development of
highly sensitive tests to detect bacteria in the biofilm state. However, the limited prior
research has not included control groups or compared the performance of different highly
sensitive tests. To address these limitations and further define the role of highly sensitive
bacterial tests in clinical practice, the investigators hypothesize that there will be
increasing bacterial burden when comparing clean broken bone surgery (1st surgery) to
implanted metal device removal (2nd surgery, bone healed) to index nonunion surgery
(subsequent surgery, bone not healed) as measured by percentage of cases being positive for
bacteria using highly sensitive bacterial tests. Further, the highly sensitive bacterial
tests (Illumina MiSeq system and Ibis T5000 biosensor) will have similar ability to quantify
the number of bacteria and differentiate bacterial species. Eligible patients will consist of
three groups. 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. Tissue
obtained at the time of surgery will be sent to the research laboratory for culture and
performance of the two highly sensitive tests. The tissue samples taken will be tissue
normally removed and discarded in the course of these particular procedures. The rates of
positivity for culture and the highly sensitive tests will be compared amongst the three
groups. Investigators will also compare bacterial count and the distribution of bacterial
species found using the two highly sensitive tests. These data will then undergo statistical
analysis against clinical data gathered from review of the patients' charts. The overall
project goal is to establish the clinical relevance of highly sensitive bacterial tests in
diagnosing infected nonunions. The ability to more accurately identify patients with
infection may lead to a change in clinical decision making with respect to surgical procedure
or antibiotic treatment. This project will develop an improved understanding of the potential
role of highly sensitive bacterial tests in diagnosing infected nonunions compared to the
current standard of care, which is growing bacteria in the laboratory under artificial
conditions.
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
We found this trial at
1
site
Baltimore, Maryland
Principal Investigator: Robert O'Toole, MD
Phone: 410-706-6823
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