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RECRUITINGPHASE4

Placement of Antibiotic Powder in Wounds During the Emergency Room

Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study

NCT03765567•The University of Texas Health Science Center at San Antonio

Summary

This is the first prospective controlled study to determine whether the topical application of vancomycin powder reduces infection-related complications when applied to open fracture injuries in the acute emergency department setting.

Detailed Description

Open fracture injuries are highly susceptible to infection and infection-related complications. The current routine treatment for these injuries includes the use of systemic IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing the amount of antibiotic that reaches the target tissue while increasing risk of injury to non-target organs. This trial aims to evaluate the effectiveness of early application of a topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual treatment, in reducing the risk of infection seen in these injuries.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

University Hospital

San Antonio, Texas, United States

San Antonio Military Medical Center

San Antonio, Texas, United States

Key Dates

Start Date

October 5, 2020

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2027

Last Updated

August 1, 2025

Enrollment

200

ESTIMATED participants

Conditions

Open Fracture

Interventions

Vancomycin

DRUG

Contacts

Robert A De Lorenzo, MD

CONTACT

210-567-0056 DeLorenzo@uthscsa.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Placement of Antibiotic Powder in Wounds During the Emergency Room

Inclusion Criteria

Exclusion Criteria

Powdered Intrawound Vancomycin in Open Fractures Trial

Evaluate Clinical and Radiological Outcomes After Limb Reconstruction Using Monorail Fixator Over Intramedullary Nailing in Tibial Open Fractures With Bone Loss

Role of Vacuum in Open Fracture Tibia Grade III Type B

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