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.
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.
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.
Parallel
Vancomycin
Drug2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
Deep-space infection rate at prophylaxis site
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
Superficial infection rate requiring post-operative medical intervention
The percentage of participants who develop an infection of the study open fracture that requires post-operative medical intervention, including addition or change of antibiotic, bedside application of incision \& drainage, needle aspiration, and bedside application of a drain.
Unplanned repeat visit rate
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Readmission rate for open fracture infection
The percentage of participants who are readmitted to the hospital due to infection or complication of the study open fracture. Included in this assessment is sepsis and sepsis-related conditions arising from an open fracture infection.
Death rate
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
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The University of Texas Health Science Center at San Antonio
Lead sponsor
United States Army Institute of Surgical Research
Collaborator
San Antonio Military Medical Center
Collaborator
