Using vancomycin powder to prevent infections in open fractures in the emergency room

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

This study tests whether using vancomycin powder directly on open fracture wounds in the emergency room can help prevent infections better than regular IV antibiotics.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 2 sites (San Antonio, Texas and 1 other locations)
• Trial ID: NCT03765567 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of applying topical vancomycin powder to open fracture wounds in the emergency department to reduce infection-related complications. Open fractures are particularly vulnerable to infections, and traditional systemic IV antibiotics may not adequately reach the affected tissues due to compromised blood supply. By administering vancomycin powder directly to the wound, the study aims to enhance antibiotic delivery and improve patient outcomes. This is the first prospective controlled study of its kind, focusing on the acute treatment of open fractures.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have sustained an open fracture of specific bones within 24 hours of injury.

Not a fit: Patients who have received prior operative care for their open fracture or those with documented allergies to vancomycin may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of infections in patients with open fractures, leading to better recovery outcomes.

How similar studies have performed: While this approach is novel in the context of open fractures, similar studies using topical antibiotics have shown promise in other surgical and trauma settings.

Eligibility criteria

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.

Where this trial is running

San Antonio, Texas and 1 other locations

• University Hospital — San Antonio, Texas, United States (RECRUITING)
• San Antonio Military Medical Center — San Antonio, Texas, United States (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Robert A De Lorenzo, MD — University of Texas
• Study coordinator: Robert A De Lorenzo, MD

Conditions: Open Fracture, infection, vancomycin, topical antibiotic, antibiotic prophylaxis