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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    1900
  • sponsor
    Major Extremity Trauma Research Consortium
Updated on 11 July 2021

Summary

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").

Description

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 365 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.

Details
Condition Post Operative Surgical Site Infection
Treatment Control group, Treatment group
Clinical Study IdentifierNCT04597008
SponsorMajor Extremity Trauma Research Consortium
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

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
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

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
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