Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

Completed · Phase 3

Conditions studied: Post Operative Surgical Site Infection

In brief

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").

Key facts

Study ID

NCT04597008

Run by

Major Extremity Trauma Research Consortium

People needed

1660

Starts

2021-06-18

Expected to finish

2025-07-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Alabama Heersink School of Medicine — Birmingham, Alabama, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Stanford University — Redwood City, 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
• 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

Full record on ClinicalTrials.gov

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