Vancomycin Powder for Open Fractures in the Emergency Room

This study is looking at whether applying vancomycin (an antibiotic powder) directly to open fracture wounds in the emergency room can help reduce infections. Open fractures are breaks in bones where the skin is also broken, making them very prone to infection. Currently, these injuries are treated with antibiotics given through a vein (IV). This study will apply vancomycin powder to the wound in addition to the usual IV antibiotics. Researchers want to see if this topical application lowers the rate of deep-space infections (infections deep within the body) within one year of the injury. You might be able to join if you are 18 or older, have an open fracture of certain bones (like the arm or leg), and the injury happened within the last 24 hours. The study is currently recruiting 200 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your infection rate will be checked within one year of your injury date.

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NCT03765567

Placement of Antibiotic Powder in Wounds During the Emergency Room

Recruiting
PHASE4Ages 18–89InterventionalPrevention
The University of Texas Health Science Center at San Antonio
~200 participants
Updated 2025-08-01 on ClinicalTrials.gov
What's tested:Vancomycin

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Deep-space infection rate at prophylaxis site
Measured over Within one year of injury date
Open Fracture
2 sites across 1 states
Texas2
  • Robert A De Lorenzo, MD · PRINCIPAL_INVESTIGATOR · University of Texas

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Eligibility criteria

Inclusion

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

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.
  • Deep-space infection rate at prophylaxis siteWithin one year of injury date

    The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.