Education and Training
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
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").
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Treatment group
- drug: Control group
Eligibility
Inclusion 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.
Exclusion Criteria:
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 - 80 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting