Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
This trial is active, not recruiting.
|Sponsor||Major Extremity Trauma Research Consortium|
|Collaborator||United States Department of Defense|
|Start date||September 2011|
|End date||September 2016|
|Trial size||600 participants|
|Trial identifier||NCT01496014, A-15737.5a|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|San Diego, CA||Naval Medical Center San Diego||no longer recruiting|
|San Francisco, CA||UCSF Medical Center||no longer recruiting|
|Denver, CO||Denver Health and Hospital Authority||no longer recruiting|
|Miami, FL||University of Miami Ryder Trauma Center||no longer recruiting|
|Tampa, FL||Florida Orthopaedic Institute||no longer recruiting|
|Atlanta, GA||Emory University Dept of Orthopaedics||no longer recruiting|
|Indianapolis, IN||OrthoIndy at St Vincent||no longer recruiting|
|Iowa City, IA||University of Iowa Hospitals & Clinics||no longer recruiting|
|Kansas City, KS||University of Kansas Medical Center||no longer recruiting|
|New Orleans, LA||Louisiana State University||no longer recruiting|
|Baltimore, MD||University of Maryland, R Adams Cowley Shock Trauma Center||no longer recruiting|
|Bethesda, MD||Walter Reed Military Medical Center||no longer recruiting|
|Bethesda, MD||Walter Reed National Military Medical Center||no longer recruiting|
|Boston, MA||Boston Medical Center||no longer recruiting|
|Grand Rapids, MI||Orthopaedic Associates of Michigan, Spectrum Health||no longer recruiting|
|Minneapolis, MN||Hennepin County Medical Center / Minneapolis||no longer recruiting|
|St Paul, MN||Regions Hospital||no longer recruiting|
|Jackson, MS||University of Mississippi Medical Center||no longer recruiting|
|St Louis, MO||Barnes Jewish Hospital||no longer recruiting|
|St. Louis, MO||St. Louis Medical Center||no longer recruiting|
|Rochester, NY||University of Rochester||no longer recruiting|
|Charlotte, NC||Carolinas Medical Center||no longer recruiting|
|Durham, NC||Duke University Hospital||no longer recruiting|
|Winston-Salem, NC||Wake Forest University Baptist Medical Center||no longer recruiting|
|Cleveland, OH||MetroHealth Medical Center||no longer recruiting|
|Columbus, OH||Ohio State University Medical Center||no longer recruiting|
|Columbus, OH||Grant Medical Center||no longer recruiting|
|Oklahoma City, OK||University of Oklahoma||no longer recruiting|
|Hershey, PA||Penn State University M.S. Hershey Medical Center||no longer recruiting|
|Philadelphia, PA||Temple University Hospital||no longer recruiting|
|Pittsburgh, PA||Allegheny General Hosptial||no longer recruiting|
|Providence, RI||Brown University/Rhode Island Hospital||no longer recruiting|
|Nashville, TN||Vanderbilt University Medical Center||no longer recruiting|
|Ft. Sam Houston, TX||San Antonio Miliary Medical Center||no longer recruiting|
|Houston, TX||UT Health: The University of Texas Health Science Center at Houston Medical School||no longer recruiting|
|Temple, TX||Scott and White Memorial Hospital||no longer recruiting|
|Salt Lake City, UT||University of Utah||no longer recruiting|
|Charlottesville, VA||University of Virginia||no longer recruiting|
|Portsmouth, VA||Naval Medical Center Portsmouth||no longer recruiting|
|Seattle, WA||Harborview Medical Center||no longer recruiting|
time frame: 1 year
Classification of Appropriate Antibiotic Care
time frame: 1 year
Male or female participants from 18 years up to 64 years old.
- All open Grade III tibia fractures (plateau, shaft, pilon) requiring a second procedure following fixation, or traumatic transtibial amputations requiring delayed primary closure, skin grafting and/ or flap coverage.
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
- Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive fixation was not performed prior to entrance into the study.
- Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
- Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
- Patients may have an existing infection of the surgical wound under treatment at the time of wound closure.
- Patients may be definitively fixed using any method (nail, plate, ex fix)
- Patients may have a fasciotomy
- Patient speaks neither English nor Spanish
- Patient is a prisoner
- Patient has been diagnosed with a severe psychiatric condition
- Patient is intellectually challenged without adequate family support
- Patient lives outside the hospital's catchment area
- Patients with planned follow-up at another medical center
|Official title||Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage: Correlation With Subsequent Post-Closure Deep Wound Infection: Bioburden Study|
|Principal investigator||Michael J Bosse, MD|
|Description||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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