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NCT03765567
Placement of Antibiotic Powder in Wounds During the Emergency Room
Conditions: Open Fracture
Sex: All
Ages: 18 Years – 89 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 200
Sponsor: The University of Texas Health Science Center at San Antonio
Location: University Hospital San Antonio Texas
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.
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.
Source: ClinicalTrials.gov (NCT03765567). StuddyBuddy aggregates publicly available trial information.