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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
Infection remains the most common and significant complication following high energy fractures. The strategies used in the prevention of deep infection following severe open fracture wounds have remained constant for the past 20 years.
This project is designed to analyze the microbiology profiles of wounds from severe tibia fractures at closure by comparing two methods: routine microbiology techniques and PCR methods using the Ibis T5000 Biosensor System. The results from both identification methods will be compared to the pathogens associated with deep surgical site infections that occur post closure of the wound. Currently it is unknown which of these methods will yield information that can lower complication rates and better function of the leg. Our goal is to perform a multi-center, prospective cohort study of wound bacterial bioburden and associated antibiotic care in severe open lower extremity fractures.
Primary Aim: In a subset of 60 patients, compare the bioburden, as detected by Ibis technology, from each of three sampling techniques (deep tissue; soft tissue composite; composite of tissue from the length and depth of the wound). Samples obtained using the most effective technique identified in this step will be processed using Ibis in subsequent tissue analysis. Effectiveness is defined as the ability to identify key wound infection-causing pathogens.
Primary Hypothesis: The composite sampling approach will be the most effective technique.
Secondary Aim: Characterize the wound bioburden at the time of definitive wound closure or coverage using the Ibis T5000 Biosensor System PCR technology as compared to standard microbiology techniques.
Hypothesis 2: The Ibis technology will detect more species of pathogens than standard microbiology techniques. The percent of patients for whom Ibis will detect all species identified by standard microbiology will be greater than 95%.
Specific Aim 3: Characterize the wound bioburden in the patients who develop deep infection within one year of wound closure, and determine the association between infecting pathogens with initial wound closure bioburden as measured jointly by Ibis and standard microbiology techniques.
Specific Aim 4: Document the variability in antibiotic selection and duration, and examine the impact of this selection on subsequent deep infection.
Hypothesis 4a: Among patients treated with antibiotic regimens that are appropriate for the pathogens identified by standard microbiology, there will be a lower probability of deep infection than among those patients who received inappropriate antibiotic regimens.
Hypothesis 4b: Among patients treated with antibiotic regimens that are appropriate for the pathogens identified by Ibis, there will be a lower probability of deep infection than among those patients who received inappropriate antibiotic regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe open fractures of the tibia bone |
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| Measure | Description | Time Frame |
|---|---|---|
| Infection | The presence of a deep surgical site infection will be defined by the criteria of the Centers for Disease Control. Deep SSI occurs within 30 days after the operation if no implant is left in place, or within one year if implant is in place and the infection appears to be related to the operation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Classification of Appropriate Antibiotic Care | An expert panel consisting of the study PI, two additional orthopaedic trauma surgeons and at least three infectious disease experts will be convened to develop a classification grid for the most common and/or expected microbial species to be found in this study and the related antibiotic treatment regimens used in the initial care of these patients. For each microbial species, the expert panel will classify a given antibiotic regimen as "appropriate" and "not appropriate", based on the best available published data. |
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Inclusion Criteria:
Exclusion Criteria:
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Particiapting METRC Trauma Centers across the country.
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Bosse, MD | Carolinas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States | ||
| UCSF Medical Center |
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Tissue
| 1 year |
| San Francisco |
| California |
| 94115 |
| United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| University of Miami Ryder Trauma Center | Miami | Florida | 33101 | United States |
| Florida Orthopaedic Institute | Tampa | Florida | 33606 | United States |
| Emory University Dept of Orthopaedics | Atlanta | Georgia | 30303 | United States |
| OrthoIndy at St Vincent | Indianapolis | Indiana | 46260 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Louisiana State University | New Orleans | Louisiana | 70112 | United States |
| University of Maryland, R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| Walter Reed Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Orthopaedic Associates of Michigan, Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Hennepin County Medical Center / Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| St. Louis Medical Center | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1070 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Grant Medical Center | Columbus | Ohio | 43215 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| Penn State University M.S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hosptial | Pittsburgh | Pennsylvania | 15212 | United States |
| Brown University/Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| San Antonio Miliary Medical Center | Fort Sam Houston | Texas | 78234-6315 | United States |
| UT Health: The University of Texas Health Science Center at Houston Medical School | Houston | Texas | 77030 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Naval Medical Center Portsmouth | Portsmouth | Virginia | 23708 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D005597 | Fractures, Open |
| D007239 | Infections |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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