Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
Purpose
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").
Condition
- Post Operative Surgical Site Infection
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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: 1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved. 2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. 3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds. 2. Patients ages 18 through 80 years.
Exclusion Criteria
- Study injury is already infected at time of study enrollment. 2. Definitive fixation of the study injury prior to enrollment in the study. 3. The patient never receives study fixation. 4. Massive myonecrosis from ipsilateral leg compartment syndrome. 5. Currently pregnant. 6. 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). 7. Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome). 8. Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Control |
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. |
|
|
Experimental Treatment |
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. |
|
Recruiting Locations
University of Alabama Heersink School of Medicine
Birmingham, Alabama 35205
Birmingham, Alabama 35205
Keck School of Medicine of USC
Los Angeles, California 90033
Los Angeles, California 90033
Stanford University
Redwood City, California 94063
Redwood City, California 94063
_University of California, San Francisco
San Francisco, California 94110
San Francisco, California 94110
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
Aurora, Colorado 80045
St Mary's University/Tenent Health
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Loyola University Chicago
Chicago, Illinois 60153
Chicago, Illinois 60153
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
Indiana University/Eskenazi Health
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
University of Kentucky
Lexington, Kentucky 40506
Lexington, Kentucky 40506
University of Maryland Shock Trauma Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Contact:
Robert O'Toole
Robert O'Toole
University of Maryland Shock Trauma/Capitol Regions
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Core Well Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
University of Mississippi Medical Center
Jackson, Mississippi 39216
Jackson, Mississippi 39216
New York Presbyterian/Hospital for Special Surgery
New York, New York 10021
New York, New York 10021
Jamaica Hospital Medical Center
Queens, New York 11418
Queens, New York 11418
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
Chapel Hill, North Carolina 27514
Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute
Charlotte, North Carolina 28203
Charlotte, North Carolina 28203
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Ohio State University Wexner Medical Center
Columbus, Ohio 43201
Columbus, Ohio 43201
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Penn State College of Medicine
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania 19106
Philadelphia, Pennsylvania 19106
Temple University
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Rhode Island Hospital/Brown University
Providence, Rhode Island 02905
Providence, Rhode Island 02905
Medical University of South Carolina -
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Vanderbilt University
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Baylor Scott & White Research Institute
Dallas, Texas 75246
Dallas, Texas 75246
UTHealth/McGovern Medical School
Houston, Texas 77030
Houston, Texas 77030
UT Health San Antonio
San Antonio, Texas 78229
San Antonio, Texas 78229
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
Inova Fairfax MEdical Campus
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298
Richmond, Virginia 23298
University of Wisconsin
Madison, Wisconsin 53705
Madison, Wisconsin 53705
More Details
- NCT ID
- NCT04597008
- Status
- Recruiting
- Sponsor
- Major Extremity Trauma Research Consortium
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.