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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