Placement of Antibiotic Powder in Wounds During the Emergency Room

Open fracture injuries are highly susceptible to infection and infection-related
complications. The current routine treatment for these injuries includes the use of systemic
IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing
the amount of antibiotic that reaches the target tissue while increasing risk of injury to
non-target organs. This trial aims to evaluate the effectiveness of early application of a
topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual
treatment, in reducing the risk of infection seen in these injuries.

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.