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

NCT04597008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1550

Last updated 2026-03-04

No results posted yet for this study

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").

Conditions

  • Post Operative Surgical Site Infection

Interventions

DRUG

Treatment group

Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation.

DRUG

Control group

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Major Extremity Trauma Research Consortium

    lead OTHER

Principal Investigators

  • Robert V O'Toole, MD, MS · University of Maryland, Department of Orthopaedic Trauma

  • Renan C Castillo, PhD · Johns Hopkins Bloomberg School of Public Health

  • Anthony R Carlini, MS · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2025-07-30
Completion
2025-07-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597008 on ClinicalTrials.gov