Fractures: Topical Antibiotic Therapy to Reduce Infection

Summary

This study focuses on adults (18-80 years old) who have a severe lower leg/ankle fracture that will be treated with a screw and plate procedure. The purpose of the study is to help identify the best treatment for severe lower leg injuries. Researchers aim to determine whether a combination of antibiotic drugs called vancomycin and tobramycin is better than vancomycin alone at preventing infection after surgery to fix severe lower leg or ankle fractures. Previous studies have shown that using antibiotics like vancomycin and tobramycin in a powder form sprinkled in the site of surgery can lead to a smaller risk for infection later. The Food and Drug Administration (FDA) has permitted the use of these drugs in powder form. Participants will be randomly assigned to 1 of 2 groups. One group will receive vancomycin powder only, and the other will receive a mix of vancomycin with tobramycin powders sprinkled into the surgical incision. All participants will receive standard-of-care treatment for their injury.


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.
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

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

Details
Disease Type/Condition

Other

Principal Investigator

Moon, Charles

Co-Investigators

Carol Lin

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001900

ClinicalTrials.gov ID

NCT04597008

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Other

Principal Investigator

Moon, Charles

Age Group

Adult

Phase

N/A

IRB Number

W81XWH-19-1-0848

ClinicalTrials.gov ID

NCT04597008

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?