Using vancomycin powder to prevent infections in open fractures in the emergency room

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of applying topical vancomycin powder to open fracture wounds in the emergency department to reduce infection-related complications. Open fractures are particularly vulnerable to infections, and traditional systemic IV antibiotics may not adequately reach the affected tissues due to compromised blood supply. By administering vancomycin powder directly to the wound, the study aims to enhance antibiotic delivery and improve patient outcomes. This is the first prospective controlled study of its kind, focusing on the acute treatment of open fractures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject or Legal Authorized Representative (LAR) is willing and able to provide written informed consent.
* Adult 18 years of age or older.
* Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.
* 24 hours or less has elapsed from the estimated time of injury to study intervention.

Exclusion Criteria:

* Time from injury \> 24 hours.
* Subjects who have received acute operative care (e.g., washout in the operating room or fixation) of the open fracture at an outside facility.
* Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable to participate in the consent process (e.g. intoxication, poly-trauma, will be enrolled into the observational arm where passive data collection will occur).
* High-potency antibiotic powder or solution applied to the wound prior to enrollment. Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will be permitted.
* Documented allergies or serious reactions to vancomycin. History of uncomplicated "red man syndrome" will not be considered a reason for exclusion.
* Pregnant subjects. If the subject is a female of childbearing potential, and she states that she is likely to be pregnant, a pregnancy test will be performed; if negative, the subject will be eligible for enrollment.
* Prisoners.
* Participation in other clinical research involving investigational antimicrobial products within 30 days of randomization.

Where it's running

• University Hospital
  San Antonio, Texas, United States Recruiting
• San Antonio Military Medical Center
  San Antonio, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Robert A De Lorenzo, MD — University of Texas
• Study coordinator: Robert A De Lorenzo, MD
• Email: DeLorenzo@uthscsa.edu
• Phone: 210-567-0056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.