Open FractureBioburdenNCT01496014
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
An observational study of Open Fracture, run by Major Extremity Trauma Research Consortium at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Open Fracture
- How many people
- 646 participants
- Where
- 40 sitesUnited States
- Study dates
- Sep 2011to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Particiapting METRC Trauma Centers across the country.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Emory University Dept of Orthopaedics
Atlanta, Georgia, 30303
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Walter Reed Military Medical Center
Bethesda, Maryland, 20889
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Boston Medical Center
Boston, Massachusetts, 02118
Carolinas Medical Center
Charlotte, North Carolina, 28232
University of Virginia
Charlottesville, Virginia, 22908
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio State University Medical Center
Columbus, Ohio, 43210
Grant Medical Center
Columbus, Ohio, 43215
Denver Health and Hospital Authority
Denver, Colorado, 80204
Duke University Hospital
Durham, North Carolina, 27710
San Antonio Miliary Medical Center
Fort Sam Houston, Texas, 78234-6315
Orthopaedic Associates of Michigan, Spectrum Health
Grand Rapids, Michigan, 49503
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030
OrthoIndy at St Vincent
Indianapolis, Indiana, 46260
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Miami Ryder Trauma Center
Miami, Florida, 33101
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Louisiana State University
New Orleans, Louisiana, 70112
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny General Hosptial
Pittsburgh, Pennsylvania, 15212
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905
University of Rochester
Rochester, New York, 14642
Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah
Salt Lake City, Utah, 84108
Naval Medical Center San Diego
San Diego, California, 92134
UCSF Medical Center
San Francisco, California, 94115
Harborview Medical Center
Seattle, Washington, 98104
Barnes Jewish Hospital
St Louis, Missouri, 63110
St. Louis Medical Center
St Louis, Missouri, 63110
Florida Orthopaedic Institute
Tampa, Florida, 33606
Scott and White Memorial Hospital
Temple, Texas, 76508
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1070
About this study
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
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.
Read the detailed 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.
- Conditions
- Open Fracture
- Keywords
- open fracture wounds, infections, tibia fractures, antibiotic therapies in severe fractures, All severe open fracture of the tibia bone
- Medical subject headings
- Fractures, Open, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe open fractures of the tibia bone | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2016
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- Major Extremity Trauma Research Consortium
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Michael J Bosse, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496014
- Sponsor's protocol ID
- A-15737.5a
- Acronym
- Bioburden
- Status last verified
- Jul 2022
- First submitted
- 7 Nov 2011
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01496014
- Acronym / sponsor ID
- Bioburden / A-15737.5a
- Conditions
- Open Fracture
- Keywords
- open fracture wounds, infections, tibia fractures, antibiotic therapies in severe fractures, All severe open fracture of the tibia bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- Major Extremity Trauma Research ConsortiumUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe open fractures of the tibia bone | – | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Particiapting METRC Trauma Centers across the country.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infection
Time frame: 1 year
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 secondary outcome
Classification of Appropriate Antibiotic Care
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Bosse, MD principal investigator
Carolinas Medical Center
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Fracture, run by Major Extremity Trauma Research Consortium at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.