Clinical trial NCT03765567: Placement of Antibiotic Powder in Wounds During the Emergency Room
Official title: Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Open Fracture
Keywords: infection
vancomycin
topical antibiotic
antibiotic prophylaxis
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Army Institute of Surgical Research
name: San Antonio Military Medical Center
First posted: 2018-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Deep-space infection rate at prophylaxis site
timeFrame: Within one year of injury date
Secondary outcomes:
measure: Superficial infection rate requiring post-operative medical intervention
timeFrame: Within one year of injury date
measure: Unplanned repeat visit rate
timeFrame: Within one year of injury date
measure: Readmission rate for open fracture infection
timeFrame: Within one year of injury date
measure: Death rate
timeFrame: Within one year of injury date
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: University of Texas
name: Robert A De Lorenzo, MD
role: PRINCIPAL_INVESTIGATOR
References: