Placement of Antibiotic Powder in Wounds During the Emergency Room

Study Overview
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Brief Summary
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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
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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.

Official Title
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Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study

Conditions
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Open Fracture

Intervention / Treatment
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* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>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<br>* 2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.<br>* Other names: Vancomycin powder;|
| No Intervention: Control Arm<br>Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician. | |
| No Intervention: Observational Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within one year of injury date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within one year of injury date | 
| Unplanned repeat visit rate | The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection. | Within one year of injury date | 
| 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. | Within one year of injury date | 
| Death rate | The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means. | Within one year of injury date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, vancomycin, topical antibiotic, antibiotic prophylaxis