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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Open Fracture
• Intervention / Treatment: Drug: Vancomycin

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Robert A De Lorenzo, MD; Phone Number: 210-567-0056; Email: DeLorenzo@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University Hospital
      • Contact: Robert DeLorenzo, MD; Phone Number: 210-567-4292; Email: delorenzo@uthscsa.edu
      • Contact: Stephanie Martinez; Phone Number: 210 450-8566; Email: martinezs13@uthscsa.edu
      • Principal Investigator: Robert A De Lorenzo, MD
    • San Antonio, Texas, United States, 78234
      • Not yet recruiting
      • San Antonio Military Medical Center
      • Principal Investigator: Steven G Schauer, DO
      • Contact: Steven G Schauer, DO; Email: steven.g.schauer.mil@mail.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: San Antonio Military Medical Center; United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Robert A De Lorenzo, MD, University of Texas

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: infection; vancomycin; antibiotic prophylaxis; topical antibiotic
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Disease Attributes; Emergencies; Fractures, Open; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: HSC20180520H; W81XWH-18-2-0074 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared through the use of the REDCap Web-based distributed data collection system. All sharing of data will conform to currently established DOD HRPO (Department of Defense Human Research Protection Office) human subject protection practices and will be in compliance with all appropriate state and federal confidentiality requirements and privacy guidelines.
• IPD Sharing Time Frame: Data will be made available within one year of study completion.
• IPD Sharing Access Criteria: Research data obtained through this study will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. While data will be provided in a timely fashion, the actual timelines of availability of requested data will be specific to the data requested and any special sensitivity of the requested data set.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No