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

Description

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").

Conditions

Post Operative Surgical Site Infection

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Study Overview

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Study Details

Study overview

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").

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures At High Risk of Infection: TOBRA - a Multicenter Randomized Controlled Trial

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

Condition
Post Operative Surgical Site Infection
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Heersink School of Medicine, Birmingham, Alabama, United States, 35205

Los Angeles

Keck School of Medicine of USC, Los Angeles, California, United States, 90033

Redwood City

Stanford University, Redwood City, California, United States, 94063

San Francisco

_University of California, San Francisco, San Francisco, California, United States, 94110

West Hollywood

Cedars Sinai, West Hollywood, California, United States, 90069

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

West Palm Beach

St Mary's University/Tenent Health, West Palm Beach, Florida, United States, 33407

Chicago

Loyola University Chicago, Chicago, Illinois, United States, 60153

Indianapolis

Indiana University School of Medicine - Methodist Hospital, Indianapolis, Indiana, United States, 46202

Indianapolis

Indiana University/Eskenazi Health, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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.
  • 1. 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Major Extremity Trauma Research Consortium,

Robert V O'Toole, MD, MS, PRINCIPAL_INVESTIGATOR, University of Maryland, Department of Orthopaedic Trauma

Renan C Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health

Anthony R Carlini, MS, STUDY_DIRECTOR, Johns Hopkins Bloomberg School of Public Health

Study Record Dates

2026-12-31