CompletedPhase 3

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

United States1,550 participantsStarted 2021-05-11

Plain-language 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").

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Deep Surgical Site Infection (SSI)

Timeframe: within 182 days of definitive fracture fixation surgery

Trial details

NCT IDNCT04597008

SponsorMajor Extremity Trauma Research Consortium

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Post Operative Surgical Site Infection trials