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

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Open Fracture

Treatments: Drug: Vancomycin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03765567

HSC20180520H

W81XWH-18-2-0074 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Drug: Vancomycin

Control Arm

No Intervention group

Description:

Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.

Observational Arm

No Intervention group

Description:

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.