Placement of Antibiotic Powder in Wounds During the Emergency Room
Recruiting now · Phase 4
Conditions studied: Open Fracture
In brief
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.
Key facts
- Study ID
- NCT03765567
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 200
- Starts
- 2020-10-05
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-08-01
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- University Hospital — San Antonio, Texas, United States (enrolling)
- San Antonio Military Medical Center — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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