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

CompletedPhase 3

Sponsor: Major Extremity Trauma Research Consortium

Conditions: Post Operative Surgical Site Infection

Interventions: Treatment group, Control group

Countries: United States

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").

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.
* Patients ages 18 through 80 years.

Exclusion Criteria:

* 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.

Locations (41)

Birmingham, Alabama, United States
Los Angeles, California, United States
Redwood City, California, United States
San Francisco, California, United States
West Hollywood, California, United States
Aurora, Colorado, United States
West Palm Beach, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Jackson, Mississippi, United States
Lebanon, New Hampshire, United States
New York, New York, United States
Queens, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
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