Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT04597008 · View on ClinicalTrials.gov ↗

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").

Interventions

  • DRUG Treatment group
  • DRUG Control group

Study Locations (20)

California

  • Keck School of Medicine of USC — Los Angeles
  • Stanford University — Redwood City
  • _University of California, San Francisco — San Francisco
  • Cedars Sinai — West Hollywood

Indiana

  • Indiana University School of Medicine - Methodist Hospital — Indianapolis
  • Indiana University/Eskenazi Health — Indianapolis

Maryland

  • University of Maryland Shock Trauma Center — Baltimore
  • University of Maryland Shock Trauma/Capitol Regions — Baltimore

Alabama

  • University of Alabama Heersink School of Medicine — Birmingham

Colorado

  • University of Colorado Anschutz Medical Campus — Aurora

Florida

  • St Mary's University/Tenent Health — West Palm Beach

Illinois

  • Loyola University Chicago — Chicago

Kentucky

  • University of Kentucky — Lexington

Trial Details

FieldValue
Enrollment Target 1,550 participants
Start Date 2021-05-11
Est. Completion 2025-07-30
Phase Phase 3

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04597008

The ClinicalTrials.gov registry entry for NCT04597008 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,550 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Post Operative Surgical Site Infection appearing as the primary indexed condition, and to 2 interventions — of which Treatment group is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04597008 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Indiana, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04597008 about?

NCT04597008 is a clinical study titled "Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA". 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").

What is the current status of trial NCT04597008?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,550 participants. The study started on 2021-05-11. Estimated completion is 2025-07-30.

What conditions does trial NCT04597008 study?

This clinical trial studies the following conditions: Post Operative Surgical Site Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04597008?

The interventions under investigation include: Treatment group (DRUG), Control group (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04597008?

This trial is sponsored by Major Extremity Trauma Research Consortium, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04597008 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial