Placement of Antibiotic Powder in Wounds During the Emergency Room
Lay 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.
Category
- Emergency Medicine
- Wounds and Injuries
- IRB Number
- 20180520HU
- NCT Number
- NCT03765567
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
Arm Groups
Study Contact
Stephanie Perez
210-450-8973
perezs11@uthscsa.edu
Principal Investigator
Robert Delorenzo