Purpose

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

IRB Number
20180520HU
NCT Number
NCT03765567
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Robert Delorenzo

Stephanie Perez
210-450-8973
perezs11@uthscsa.edu



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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)
Condition
  • Open Fracture

    • Arm Groups

    ArmDescriptionIntervention
    No Intervention

    Control Arm

    		Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
    Experimental

    Intervention Arm

    		Subjects randomized to the Intervention Arm will receive usual care plus two (2) grams of Vancomycin powder administered topically. In the emergency room prior to surgical intervention, a qualified member of the study team or clinical team member will apply 2 grams of vancomycin powder directly to the open fracture site such that all visible surfaces of the wound are completely and uniformly covered, including bone edges.
  • Drug: Vancomycin

    2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.

    Other names:

    • NDC (National Drug Code) 67457-340-01
    • Topical vancomycin
    • Vancomycin powder

    • No Intervention

    Observational Arm

    		Subjects who otherwise meet the criteria to be included in the study but are not able to provide consent, either themselves or through a Legally Authorized Representative, will be placed in the Observational Arm and receive usual care with no experimental intervention.