Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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").

Official Title

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

Details

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.

Keywords

Post Operative Surgical Site Infection, Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities, Infections, Communicable Diseases, Surgical Wound Infection, Treatment group

Eligibility

You can join if…

Open to people ages 18-80

  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.

You CAN'T join if...

  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.

Locations

  • _University of California, San Francisco accepting new patients
    San Francisco California 94110 United States
  • Stanford University accepting new patients
    Redwood City California 94063 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Major Extremity Trauma Research Consortium
ID
NCT04597008
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 1900 study participants
Last Updated