<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765567</url>
  </required_header>
  <id_info>
    <org_study_id>HSC20180520H</org_study_id>
    <secondary_id>W81XWH-18-2-0074</secondary_id>
    <nct_id>NCT03765567</nct_id>
  </id_info>
  <brief_title>Placement of Antibiotic Powder in Wounds During the Emergency Room</brief_title>
  <acronym>POWDER</acronym>
  <official_title>Placement of Antibiotic Powder in Wounds During the Emergency Room (POWDER) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Army Institute of Surgical Research</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>San Antonio Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the first prospective controlled study to determine whether the topical application&#xD;
      of vancomycin powder reduces infection-related complications when applied to open fracture&#xD;
      injuries in the acute emergency department setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open fracture injuries are highly susceptible to infection and infection-related&#xD;
      complications. The current routine treatment for these injuries includes the use of systemic&#xD;
      IV antibiotics. However, open fracture injuries often have compromised blood supply, reducing&#xD;
      the amount of antibiotic that reaches the target tissue while increasing risk of injury to&#xD;
      non-target organs. This trial aims to evaluate the effectiveness of early application of a&#xD;
      topical vancomycin antibiotic powder on open fracture wounds, in combination with the usual&#xD;
      treatment, in reducing the risk of infection seen in these injuries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2020</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Deep-space infection rate at prophylaxis site</measure>
    <time_frame>Within one year of injury date</time_frame>
    <description>The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Superficial infection rate requiring post-operative medical intervention</measure>
    <time_frame>Within one year of injury date</time_frame>
    <description>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 &amp; drainage, needle aspiration, and bedside application of a drain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned repeat visit rate</measure>
    <time_frame>Within one year of injury date</time_frame>
    <description>The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rate for open fracture infection</measure>
    <time_frame>Within one year of injury date</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death rate</measure>
    <time_frame>Within one year of injury date</time_frame>
    <description>The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Open Fracture</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
    <other_name>NDC (National Drug Code) 67457-340-01</other_name>
    <other_name>Topical vancomycin</other_name>
    <other_name>Vancomycin powder</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject or Legal Authorized Representative (LAR) is willing and able to provide&#xD;
             written informed consent.&#xD;
&#xD;
          -  Adult 18 years of age or older.&#xD;
&#xD;
          -  Open fracture of the humerus, radius, ulna, femur, tibia, and/or fibula.&#xD;
&#xD;
          -  24 hours or less has elapsed from the estimated time of injury to study intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Time from injury &gt; 24 hours.&#xD;
&#xD;
          -  Subjects who have received acute operative care (e.g., washout in the operating room&#xD;
             or fixation) of the open fracture at an outside facility.&#xD;
&#xD;
          -  Subject or LAR speaks neither English nor Spanish. Note that subjects that are unable&#xD;
             to participate in the consent process (e.g. intoxication, poly-trauma, will be&#xD;
             enrolled into the observational arm where passive data collection will occur).&#xD;
&#xD;
          -  High-potency antibiotic powder or solution applied to the wound prior to enrollment.&#xD;
             Simple ointment (i.e., bacitracin ointment) or antibiotic-impregnated dressings will&#xD;
             be permitted.&#xD;
&#xD;
          -  Documented allergies or serious reactions to vancomycin. History of uncomplicated &quot;red&#xD;
             man syndrome&quot; will not be considered a reason for exclusion.&#xD;
&#xD;
          -  Pregnant subjects. If the subject is a female of childbearing potential, and she&#xD;
             states that she is likely to be pregnant, a pregnancy test will be performed; if&#xD;
             negative, the subject will be eligible for enrollment.&#xD;
&#xD;
          -  Prisoners.&#xD;
&#xD;
          -  Participation in other clinical research involving investigational antimicrobial&#xD;
             products within 30 days of randomization.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert A De Lorenzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robert A De Lorenzo, MD</last_name>
    <phone>210-567-0056</phone>
    <email>DeLorenzo@uthscsa.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert DeLorenzo, MD</last_name>
      <phone>210-567-4292</phone>
      <email>delorenzo@uthscsa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Stephanie Martinez</last_name>
      <phone>210 450-8566</phone>
      <email>martinezs13@uthscsa.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Robert A De Lorenzo, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Steven G Schauer, DO</last_name>
      <email>steven.g.schauer.mil@mail.mil</email>
    </contact>
    <investigator>
      <last_name>Steven G Schauer, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infection</keyword>
  <keyword>vancomycin</keyword>
  <keyword>topical antibiotic</keyword>
  <keyword>antibiotic prophylaxis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Fractures, Open</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data will be made available within one year of study completion.</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765567
org study id: HSC20180520H
secondary id: W81XWH-18-2-0074
nct id: NCT03765567
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Deep-space infection rate at prophylaxis site
time frame: Within one year of injury date
description: The percentage of participants who develop an infection of the study open fracture requiring post-operative surgical intervention within one year of injury.
measure: Superficial infection rate requiring post-operative medical intervention
time frame: Within one year of injury date
description: 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.
measure: Unplanned repeat visit rate
time frame: Within one year of injury date
description: The percentage of participants who experience an unscheduled medical encounter related to open fracture-site infection.
measure: Readmission rate for open fracture infection
time frame: Within one year of injury date
description: 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.
measure: Death rate
time frame: Within one year of injury date
description: The rate of death among participants from presumed or documented open fracture site infection, determined by documentation through reliable diagnostic means.
arm group label: Intervention Arm
arm group type: Experimental
description: 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.
arm group label: Control Arm
arm group type: No Intervention
description: Subjects randomized to the Control Arm will receive usual care for open long bone fracture as determined by the treating physician.
arm group label: Observational Arm
arm group type: No Intervention
description: 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.
intervention type: Drug
intervention name: Vancomycin
description: 2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
arm group label: Intervention Arm
other name: NDC (National Drug Code) 67457-340-01
other name: Topical vancomycin
other name: Vancomycin powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Robert A De Lorenzo, MD
role: Principal Investigator
affiliation: University of Texas
last name: Robert A De Lorenzo, MD
phone: 210-567-0056
email: DeLorenzo@uthscsa.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Fractures, Open
mesh term: Vancomycin
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data will be made available within one year of study completion.
ipd 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.