Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
Bioburden
1 other identifier
observational
646
1 country
40
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 5, 2026
July 1, 2022
5 years
November 7, 2011
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
Classification of Appropriate Antibiotic Care
1 year
Study Arms (1)
severe open fractures of the tibia bone
Eligibility Criteria
Particiapting METRC Trauma Centers across the country.
You may qualify if:
- 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 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Naval Medical Center San Diego
San Diego, California, 92134, United States
UCSF Medical Center
San Francisco, California, 94115, United States
Denver Health and Hospital Authority
Denver, Colorado, 80204, United States
University of Miami Ryder Trauma Center
Miami, Florida, 33101, United States
Florida Orthopaedic Institute
Tampa, Florida, 33606, United States
Emory University Dept of Orthopaedics
Atlanta, Georgia, 30303, United States
OrthoIndy at St Vincent
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Louisiana State University
New Orleans, Louisiana, 70112, United States
University of Maryland, R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
Walter Reed Military Medical Center
Bethesda, Maryland, 20889, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Orthopaedic Associates of Michigan, Spectrum Health
Grand Rapids, Michigan, 49503, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, 55415, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
St. Louis Medical Center
St Louis, Missouri, 63110, United States
University of Rochester
Rochester, New York, 14642, United States
Carolinas Medical Center
Charlotte, North Carolina, 28232, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157-1070, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Penn State University M.S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hosptial
Pittsburgh, Pennsylvania, 15212, United States
Brown University/Rhode Island Hospital
Providence, Rhode Island, 02905, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
San Antonio Miliary Medical Center
Fort Sam Houston, Texas, 78234-6315, United States
UT Health: The University of Texas Health Science Center at Houston Medical School
Houston, Texas, 77030, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
University of Utah
Salt Lake City, Utah, 84108, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Biospecimen
Tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Bosse, MD
Carolinas Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
December 21, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2016
Study Completion
June 30, 2022
Last Updated
May 5, 2026
Record last verified: 2022-07