Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
a study on Open Fracture
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.
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
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.
Open Fracture open fracture wounds infections tibia fractures antibiotic therapies in severe fractures All severe open fracture of the tibia bone Fractures, Open
You can join if…
Open to people ages 18–64
- 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
You CAN'T join if...
- 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
- UCSF Medical Center
San Francisco, California, 94115, United States
- Naval Medical Center San Diego
San Diego, California, 92134, United States
- University of Utah
Salt Lake City, Utah, 84108, United States
- Harborview Medical Center
Seattle, Washington, 98104, United States
- Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
- University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
- San Antonio Miliary Medical Center
Ft. Sam Houston, Texas, 78234-6315, United States
- Scott and White Memorial Hospital
Temple, Texas, 76508, United States
- University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
- UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030, United States
- Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415, United States
- Regions Hospital
St Paul, Minnesota, 55101, United States
- University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
- Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
- St. Louis Medical Center
St. Louis, Missouri, 63110, United States
- University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
- Louisiana State University
New Orleans, Louisiana, 70112, United States
- OrthoIndy at St Vincent
Indianapolis, Indiana, 46260, United States
- Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
- Orthopaedic Associates of Michigan, Spectrum Health
Grand Rapids, Michigan, 49503, United States
- Ohio State University Medical Center
Columbus, Ohio, 43210, United States
- Grant Medical Center
Columbus, Ohio, 43215, United States
- Emory University Dept of Orthopaedics
Atlanta, Georgia, 30303, United States
- MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
- Allegheny General Hosptial
Pittsburgh, Pennsylvania, 15212, United States
- Carolinas Medical Center
Charlotte, North Carolina, 28232, United States
- Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1070, United States
- Florida Orthopaedic Institute
Tampa, Florida, 33606, United States
- University of Rochester
Rochester, New York, 14642, United States
- University of Virginia
Charlottesville, Virginia, 22908, United States
- Duke University Hospital
Durham, North Carolina, 27710, United States
- Walter Reed Military Medical Center
Bethesda, Maryland, 20889, United States
- Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
- Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
- University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
- Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
- Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
- University of Miami Ryder Trauma Center
Miami, Florida, 33101, United States
- Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905, United States
- Boston Medical Center
Boston, Massachusetts, 02118, United States
- in progress, not accepting new patients
- Start Date
- Completion Date
- Major Extremity Trauma Research Consortium
- Study Type
- Last Updated
- December 22, 2016