Placement of Antibiotic Powder in Wounds During the Emergency Room

Description

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.

Conditions

Open Fracture

Study Overview

Study Details

Study overview

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.

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

Placement of Antibiotic Powder in Wounds During the Emergency Room

Condition
Open Fracture
Intervention / Treatment

-

Contacts and Locations

San Antonio

University Hospital, San Antonio, Texas, United States, 78229

San Antonio

San Antonio Military Medical Center, San Antonio, Texas, United States, 78234

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Robert A De Lorenzo, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

2025-06