Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Deep-space infection rate at prophylaxis site
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Vancomycin (Drug)
Outcomes
Primary Outcomes
Deep-space infection rate at prophylaxis site
Time Frame: Within one year of injury date
The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
Secondary Outcomes
- Readmission rate for open fracture infection(Within one year of injury date)
- Death rate(Within one year of injury date)
- Unplanned repeat visit rate(Within one year of injury date)
- Superficial infection rate requiring post-operative medical intervention(Within one year of injury date)