Phase
Condition
N/ATreatment
Standard of care
Vancomycin and Tobramycin
Clinical Study ID
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Injury meeting at least one of the following criteria:
Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon)requiring a second procedure for final debridement and definitive coverage /closure following the index stabilization
Gustilo type IIIB ankle fractures (OTA 44)
Gustilo type IIIB calcaneus fractures (OTA 82)
Gustilo type IIIB talus fractures (OTA 81)
Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flapcoverage
Ages 18 - 64 years inclusive
Patients may have risk factors for infection including diabetes, immunosuppressionfrom 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 footinjuries.
Patients may be treated initially at an outside institution prior to transfer to thestudy institution, as long as the definitive wound closure or coverage was notperformed prior to entrance into the study.
Patients with bilateral injuries that meet inclusion criteria may be included, butonly the limb rated as "more severe" by the treating surgeon will be enrolled in thestudy.
Patients may have co-existing non-tibial or hindfoot infection, with or withoutantibiotic treatment.
Patients may be definitively stabilized using any method (nail, plate, ex fix orcast).
Patients may have a fasciotomy.
Exclusion
Exclusion Criteria:
Patient in current therapy for a wound, implant or fracture site infection relatedto the study site.
Patient likely to have difficulty maintaining follow-up, including:
Diagnosis of a severe psychiatric condition
Intellectually challenged without adequate family support
Resides outside of the hospital's catchment area
Planning to follow-up at another medical center
Being a prisoner
Not having a means of contact (address, cell phone, home phone, e-mail)
Study Design
Study Description
Connect with a study center
Stanford University
Redwood City, California 94063
United StatesActive - Recruiting
University of California at San Francisco
San Francisco, California 94110
United StatesActive - Recruiting
_University of California, San Francisco
San Francisco, California 94110
United StatesActive - Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
St Mary's University/Tenent Health
West Palm Beach, Florida 33407
United StatesActive - Recruiting
Emory University School of Medicine
Atlanta, Georgia 30303
United StatesActive - Recruiting
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Indiana University/Eskenazi Health
Indianapolis, Indiana 46202
United StatesActive - Recruiting
University of Kentucky
Lexington, Kentucky 40506
United StatesActive - Recruiting
LSU Health Sciences
New Orleans, Louisiana 70112
United StatesActive - Recruiting
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland 21201
United StatesActive - Recruiting
Walter Reed Military Medical Center
Bethesda, Maryland 20889
United StatesActive - Recruiting
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts 02115
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota 55415
United StatesActive - Recruiting
University of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesActive - Recruiting
Dartmouth Hitchcock
Lebanon, New Hampshire 03766
United StatesActive - Recruiting
Jamaica Hospital Medical Center
Jamaica, New York 11418
United StatesActive - Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28203
United StatesActive - Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
METROHealth
Cleveland, Ohio 44109
United StatesActive - Recruiting
Ohio State University Wexner Medical Center
Columbus, Ohio 43201
United StatesActive - Recruiting
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Temple University
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Brown University/Rhode Island Hospital
Providence, Rhode Island 02905
United StatesActive - Recruiting
Rhode Island Hospital/Brown University
Providence, Rhode Island 02905
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
University of Texas Health Science Center - Houston
Houston, Texas 77030
United StatesActive - Recruiting
Texas Tech University Health Science Center
Lubbock, Texas 79430
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Inova Fairfax MEdical Campus
Falls Church, Virginia 22042
United StatesActive - Recruiting
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298
United StatesActive - Recruiting
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