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

B
Brian Mullis, MD

Primary Investigator

Enrolling By Invitation
18-80 years
All
Phase 3
1900 participants needed
1 Location

Brief description of study

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 ofbial plateau and tibial pilon fractures at high risk of infection (collectively consideredhe "study injuries").

Detailed description of study

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the studyjury within 365 days of definitive fracture fixation surgery in patients allocated tove a combination of local Vancomycin and Tobramycin powders compared to patientsd to local Vancomycin powder.
Sensitivity Analyses: A series of sensitivity analyses will be conducted to look atve measures of deep SSI under Specific Aim 1. These sensitivity analyses willder the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culturegative 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 antibiotich arm.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Post Operative Surgical Site Infection
  • Age: Between 18 Years - 80 Years
  • Gender: All

Inclusion Criteria:
  1. Tibial plateau or tibial pilon fractures that is treated operatively with plate andw fixation AND at least one of the following characteristics indicative of higherk of infection:
    1. Initially treated with an external fixation and treated definitively more than 3days later after swelling has resolved.
    2. Any open type I, II, or IIIA fracture, regardless of timing of definitive.
    3. Tibia fracture is associated with ipsilateral leg compartment syndrome andy 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 timejury, those who are intellectually challenged without adequate family support, orunwilling to provide phone and address contact information).
  7. Patients with allergies, drug administration reactions, or other sensitivities toVancomycin (such as a history of Redman's Syndrome).
  8. Patients with allergies, drug administration reactions, or other sensitivities toTobramycin or other aminoglycosides.

Updated on 01 Aug 2024. Study ID: W81XWH-19-1-0848
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