Can antibiotic powder stop infections in open fractures?

NCT ID NCT04872400

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether putting antibiotic powder (vancomycin or tobramycin) directly into open fracture wounds right after injury can prevent infections. Twenty adults with severe open fractures of the arm or leg took part. The goal was to see if this simple step reduces surgical site infections and helps bones heal properly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Vancomycin or Tobramycin powder applied directly to the wound
What this could lead to: If it works, this could provide a simple way to reduce infections after severe open fractures, potentially shortening hospital stays and lowering costs.
What could go wrong: This is a very small, completed Phase 4 trial with only 20 participants, so results may not apply to everyone. The approach is already used in practice, so major breakthroughs are unlikely.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

20 people

The number who actually took part.

Started

Jun 2021

Finished

Sep 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject or proxy willing and able to provide written informed consent. * Age between 18 years and 80 years (inclusive), with an upper or lower extremity Gustilo Type II, IIIA, or IIIB open fractures requiring debridement and internal fixation. * Open extremity fractures * Time from injury to study intervention 24 hours or less Exclusion Criteria: * Individuals under the age of 18 years or over 80 years * Type I or IIIC open fractures * Over 24 hours from time of injury * Subjects who have received acute operative care of the open fracture at an outside facility prior to presenting at the Emergency Department. * Open fractures distal to the wrist and midfoot * History of chronic infection in the extremity involved. * Subjects who are currently pregnant * Subjects who are Prisoners * Subjects with a known allergy to vancomycin or tobramycin * Subjects with a condition or social circumstances that would reduce adherence and follow-up. * Subjects Participating in other clinical research involving investigational antimicrobial products within 30 days of randomization.

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Open Infections injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-bacterial agents Extremity fracture lower Extremity fractures upper Fractures, bone Fractures, open Wounds and injuries--infections

Can antibiotic powder stop infections in open fractures?

What the study statuses mean