Skip to main content

Summary

for people ages 18–64 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Details

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.

Keywords

Open Fracture open fracture wounds infections tibia fractures antibiotic therapies in severe fractures All severe open fracture of the tibia bone Fractures, Open

Eligibility

You can join if…

Open to people ages 18–64

  1. 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.
  2. Ages 18 - 64 years inclusive
  3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
  4. Patients may have a traumatic brain injury.
  5. Patients may have other fractures including spine, upper extremity fractures,contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
  6. 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.
  7. 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.
  8. Patients may have co-existing non-tibial infection, with or without antibiotic treatment.
  9. Patients may have an existing infection of the surgical wound under treatment at the time of wound closure.
  10. . Patients may be definitively fixed using any method (nail, plate, ex fix)
  11. . Patients may have a fasciotomy

You CAN'T join if...

  1. Patient speaks neither English nor Spanish
  2. Patient is a prisoner
  3. Patient has been diagnosed with a severe psychiatric condition
  4. Patient is intellectually challenged without adequate family support
  5. Patient lives outside the hospital's catchment area
  6. Patients with planned follow-up at another medical center

Locations

  • 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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT01496014
Study Type
Observational
Last Updated
December 22, 2016