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Using antibiotics to prevent infections after surgery for certain fractures

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

Phase 3 Interventional Major Extremity Trauma Research Consortium · NCT04597008

This study is testing whether a mix of two antibiotics can help prevent infections after surgery for certain serious leg fractures.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1900 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorMajor Extremity Trauma Research Consortium Academic / other
Locations41 sites (Birmingham, Alabama and 40 other locations)
Trial IDNCT04597008 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a combination of Vancomycin and Tobramycin powders in reducing the incidence of deep surgical site infections (SSI) following operative treatment of high-risk tibial plateau and tibial pilon fractures. Participants will be randomly assigned to receive either the combination treatment or Vancomycin alone, and the outcomes will be measured over a period of 182 days post-surgery. The study will also assess the safety of the treatments by monitoring antibiotic resistance patterns. Sensitivity analyses will explore various infection types to provide a comprehensive understanding of the treatment's impact.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with tibial plateau or tibial pilon fractures treated operatively and exhibiting characteristics that indicate a higher risk of infection.

Not a fit: Patients with existing infections at the time of enrollment or those who have already undergone definitive fixation of the injury will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of post-operative infections in patients with high-risk fractures.

How similar studies have performed: Other studies have shown promise in using local antibiotic therapies to prevent infections in surgical settings, suggesting a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Post Operative Surgical Site InfectionSurgical site infection risk preventionBacterial species type and antibacterial sensitivities
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.