POWDER: Placement of Antibiotic Powder in Wounds During the Emergency Room

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Recruiting

CT.gov ID

NCT03765567

Collaborator

United States Army Institute of Surgical Research (U.S. Fed), San Antonio Military Medical Center (U.S. Fed)

200

Enrollment

Locations

Arms

26.9

Anticipated Duration (Months)

100

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Fracture	Drug: Vancomycin	Phase 4

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

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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: Control Arm 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 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.

Arm

Intervention/Treatment

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: Control Arm

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

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.

Outcome Measures

Primary Outcome Measures

Deep-space infection rate at prophylaxis site [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 Outcome Measures

Superficial infection rate requiring post-operative medical intervention [Within one year of injury date]
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 [Within one year of injury date]
The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
Readmission rate for open fracture infection [Within one year of injury date]
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 [Within one year of injury date]
The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.