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Placement of Antibiotic Powder in Wounds During the Emergency Room
RecruitingPhase 4
Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
Who can join
Ages 18 to 89 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Vancomycin (drug)
Sponsor: The University of Texas Health Science Center at San Antonio · Participants: 200 · Started: Oct 5, 2020
Contact the study team
- Robert A De Lorenzo, MD · Phone: 210-567-0056
Official record on ClinicalTrials.gov — NCT03765567
Locations in the U.S.
| Texas | San Antonio Military Medical Center, San Antonio (Not yet recruiting) University Hospital, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.