Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
- Conditions
- Post Operative Surgical Site Infection
- Interventions
- Drug: Control groupDrug: Treatment group
- Registration Number
- NCT04597008
- Lead Sponsor
- Major Extremity Trauma Research Consortium
- Brief Summary
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").
- Detailed Description
Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 182 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder.
Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.
Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1900
-
Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:
- Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.
- Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
- Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.
-
Patients ages 18 through 80 years.
- Study injury is already infected at time of study enrollment.
- Definitive fixation of the study injury prior to enrollment in the study.
- The patient never receives study fixation.
- Massive myonecrosis from ipsilateral leg compartment syndrome.
- Currently pregnant.
- Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information).
- Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
- Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Control group Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure. Treatment Treatment group Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.
- Primary Outcome Measures
Name Time Method Deep Surgical Site Infection (SSI) within 182 days of definitive fracture fixation surgery Compare the proportion of deep SSIs of the study injury within 182 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
University of Alabama Heersink School of Medicine
🇺🇸Birmingham, Alabama, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
_University of California, San Francisco
🇺🇸San Francisco, California, United States
Cedars Sinai
🇺🇸West Hollywood, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Stanford University
🇺🇸Redwood City, California, United States
St Mary's University/Tenent Health
🇺🇸West Palm Beach, Florida, United States
Loyola University Chicago
🇺🇸Chicago, Illinois, United States
Indiana University School of Medicine - Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Indiana University/Eskenazi Health
🇺🇸Indianapolis, Indiana, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
LSU Health Sciences
🇺🇸New Orleans, Louisiana, United States
University of Maryland Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
University of Maryland Shock Trauma/Capitol Regions
🇺🇸Baltimore, Maryland, United States
Harvard/Mass General/Brigham Hospitals
🇺🇸Boston, Massachusetts, United States
Core Well Health
🇺🇸Grand Rapids, Michigan, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Dartmouth Hitchcock
🇺🇸Lebanon, New Hampshire, United States
New York Presbyterian/Hospital for Special Surgery
🇺🇸New York, New York, United States
Jamaica Hospital Medical Center
🇺🇸Queens, New York, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute
🇺🇸Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
METROHealth
🇺🇸Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
University of Pennsylvania Perelman School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital/Brown University
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina -
🇺🇸Charleston, South Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
UTHealth/McGovern Medical School
🇺🇸Houston, Texas, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax MEdical Campus
🇺🇸Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
🇺🇸Richmond, Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States