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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03765567
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : March 2, 2022
Sponsor:
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

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.

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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

Resource links provided by the National Library of Medicine


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.



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.



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765567


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

Locations
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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
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Principal Investigator: Robert A De Lorenzo, MD University of Texas
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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    Key Record Dates
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.

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