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

• ClinicalTrials.gov Identifier: NCT03765567
• Recruitment Status: Recruiting
• First Posted: December 5, 2018
• Last Update Posted: March 2, 2022
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: United States Army Institute of Surgical Research; San Antonio Military Medical Center
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Open Fracture	Drug: Vancomycin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: January 2023
• Estimated Study Completion Date: January 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Deep-space infection rate at prophylaxis site [ Time Frame: Within one year of injury date ]
   The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.

Secondary Outcome Measures :

1. Superficial infection rate requiring post-operative medical intervention [ Time Frame: Within one year of injury date ]
   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.
2. Unplanned repeat visit rate [ Time Frame: Within one year of injury date ]
   The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
3. Readmission rate for open fracture infection [ Time Frame: Within one year of injury date ]
   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.
4. Death rate [ Time Frame: Within one year of injury date ]
   The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Robert A De Lorenzo, MD; 210-567-0056; DeLorenzo@uthscsa.edu

Locations

United States, Texas

University Hospital; Recruiting

San Antonio, Texas, United States, 78229

Contact: Robert DeLorenzo, MD 210-567-4292 delorenzo@uthscsa.edu

Contact: Stephanie Martinez 210 450-8566 martinezs13@uthscsa.edu

Principal Investigator: Robert A De Lorenzo, MD

San Antonio Military Medical Center; Not yet recruiting

San Antonio, Texas, United States, 78234

Contact: Steven G Schauer, DO steven.g.schauer.mil@mail.mil

Principal Investigator: Steven G Schauer, DO

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

United States Army Institute of Surgical Research

San Antonio Military Medical Center

Investigators

• Principal Investigator: Robert A De Lorenzo, MD; University of Texas

More Information

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT03765567
• Other Study ID Numbers: HSC20180520H; W81XWH-18-2-0074 ( Other Grant/Funding Number: Department of Defense )
• First Posted: December 5, 2018
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: Data will be made available within one year of study completion.
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The University of Texas Health Science Center at San Antonio:

infection; vancomycin; topical antibiotic; antibiotic prophylaxis

Additional relevant MeSH terms:

Emergencies; Fractures, Open; Disease Attributes; Pathologic Processes; Fractures, Bone; Wounds and Injuries; Vancomycin; Anti-Bacterial Agents; Anti-Infective Agents