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Can wound bacteria predict infection after severe leg fractures?

NCT ID NCT01496014

Knowledge-focused Sponsor: Major Extremity Trauma Research Consortium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examined bacteria in severe leg wounds of 646 adults (ages 18-64) with open tibia fractures or traumatic amputations. Researchers took samples at the time of wound closure to see if certain bacteria led to deep infections within 30 days to one year. The goal was to better understand infection risks and guide antibiotic use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

646 people

The number who actually took part.

Start date

Sep 2011

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Particiapting METRC Trauma Centers across the country.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Open Infections tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Open fracture

Contacts and locations

Locations

  • Allegheny General Hosptial

    Pittsburgh, Pennsylvania, 15212, United States

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Brown University/Rhode Island Hospital

    Providence, Rhode Island, 02905, United States

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232, United States

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204, United States

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

  • Emory University Dept of Orthopaedics

    Atlanta, Georgia, 30303, United States

  • Florida Orthopaedic Institute

    Tampa, Florida, 33606, United States

  • Grant Medical Center

    Columbus, Ohio, 43215, United States

  • Harborview Medical Center

    Seattle, Washington, 98104, United States

  • Hennepin County Medical Center / Minneapolis

    Minneapolis, Minnesota, 55415, United States

  • Louisiana State University

    New Orleans, Louisiana, 70112, United States

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109, United States

  • Naval Medical Center Portsmouth

    Portsmouth, Virginia, 23708, United States

  • Naval Medical Center San Diego

    San Diego, California, 92134, United States

  • Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • OrthoIndy at St Vincent

    Indianapolis, Indiana, 46260, United States

  • Orthopaedic Associates of Michigan, Spectrum Health

    Grand Rapids, Michigan, 49503, United States

  • Penn State University M.S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Regions Hospital

    Saint Paul, Minnesota, 55101, United States

  • San Antonio Miliary Medical Center

    Fort Sam Houston, Texas, 78234-6315, United States

  • Scott and White Memorial Hospital

    Temple, Texas, 76508, United States

  • St. Louis Medical Center

    St Louis, Missouri, 63110, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • UCSF Medical Center

    San Francisco, California, 94115, United States

  • UT Health: The University of Texas Health Science Center at Houston Medical School

    Houston, Texas, 77030, United States

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Maryland, R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201, United States

  • University of Miami Ryder Trauma Center

    Miami, Florida, 33101, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1070, United States

  • Walter Reed Military Medical Center

    Bethesda, Maryland, 20889, United States

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889, United States

More trials for these conditions

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