Placement of Antibiotic Powder in Wounds During the Emergency Room

Open Fracture Clinical Trial

— POWDER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03765567
• Other study ID #: HSC20180520H
• Secondary ID: W81XWH-18-2-0074
• Status: Recruiting
• Phase: Phase 4
• Start date: October 5, 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Robert A De Lorenzo, MD
• Phone: 210-567-0056
• Email: DeLorenzo[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Fractures, Open
• Open Fracture

Intervention

Drug:
• Vancomycin
2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center	San Antonio	Texas
United States	University Hospital	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	San Antonio Military Medical Center, United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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