<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/NCT03248154</url>
  </required_header>
  <id_info>
    <org_study_id>16-00244</org_study_id>
    <nct_id>NCT03248154</nct_id>
  </id_info>
  <brief_title>Biofilm Infection in Adults and Children Burn Injury</brief_title>
  <official_title>Burn Biofilm Infection in Adults and Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gayle Gordillo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <brief_summary>
    <textblock>
      The objective of the study is to analyze the different implications (such as graft loss and&#xD;
      conversion of indeterminate depth burns) of biofilm infections in burn patients.&#xD;
      Additionally, it also aims at comparing children's resistance to biofilm infection at wound&#xD;
      site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be recruited from three different age groups: 2-18 years old, 18-49 years old,&#xD;
      and ≥ 50 years old. 150 patients will be enrolled in each age group for arms 1 and 2. Arm 3&#xD;
      consists of all patients enrolled in the study and involves drawing whole blood for analyzing&#xD;
      cytokine response. Subjects will have at day 0, 3, 7, 14, 21, 28 +/- 2 days (as applicable&#xD;
      until graft surgery occurs).At each study visit the following will be collected: burn wound&#xD;
      data [Lund-Brower Chart, TBSA burn size, date of onset, length, width, area, depth of burn&#xD;
      injury (as applicable), Standard of Care (SoC) treatment for burn] will be recorded, SoC labs&#xD;
      since the onset of the burn wounds will be recorded (CBC w/ diff and glucose as applicable),&#xD;
      digital imaging of the burn injury(s), Laser Doppler Imaging (LDI) will also be perfomed.&#xD;
      Biopsies will be collected depending on the size of injury (4 from 2cm² burn size, to 10 from&#xD;
      &gt;8cm² burn size). Blister fluid will be collected by draining the fluid with a needle and&#xD;
      syringe.Subjects in arm 2 will receive their Standard of Care (SoC) dressing prescribed by&#xD;
      their provider or will receive the study dressing, 4x4 Procellera that will be applied to a&#xD;
      specific area of the burn injury.&#xD;
&#xD;
      2 weeks after the grafting surgery, subjects will return for study visits at day 14, 21, 28&#xD;
      post-grafting where the following activities will be completed - burn wound data and&#xD;
      medication review, digital image of the burn injury(s), LDI imaging, HUSD imaging,&#xD;
      trans-epidermal water loss (TEWL) measurement. Whole blood will be collected.&#xD;
&#xD;
      Each subjects' medical chart will be followed for 3 months post completion of the study to&#xD;
      identify patient outcomes (i.e. wound closure data, infection status/type, treatment status,&#xD;
      surgical outcomes/complications - graft loss, patient death as applicable).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    did not receive funding&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of biofilm infection in burns</measure>
    <time_frame>4 weeks</time_frame>
    <description>Tissue biopsies will be tested for presence of bacteria using SEM and culture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessing graft loss as a result of biofilm infection</measure>
    <time_frame>4 weeks post grafting surgery</time_frame>
    <description>TEWL measurement (g/square meter/h) as an indicator of lost barrier function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burn depth measurement</measure>
    <time_frame>4 weeks</time_frame>
    <description>Harmonic Ultrasound &amp; Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Examining children vs adults for biofilm resistance</measure>
    <time_frame>2 weeks post grafting surgery</time_frame>
    <description>TNF-a measurement through cytokine assay (pg/ml)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Thermal Burn</condition>
  <condition>Wound</condition>
  <arm_group>
    <arm_group_label>Immunocompetent with 2-14% TBSA</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness?</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunocompromised with &gt;=20% TBSA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immunocompromised patients with large thermal burn &gt;=20% TBSA. Higher bacterial burden with biofilm infection will result in higher rates of graft loss. Does application of a wireless electroceutical dressing (Procellera) lower biofilm burden compared to burn subjects receiving standard of care therapy?</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peripheral blood - all subjects</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection?</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Procellera</intervention_name>
    <description>burn dressing</description>
    <arm_group_label>Immunocompromised with &gt;=20% TBSA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Aim 3 is included in all criteria):&#xD;
&#xD;
        Aim 1 and 2:&#xD;
&#xD;
          -  Ages 2 yrs. and older&#xD;
&#xD;
        Aim 1:&#xD;
&#xD;
          -  Thermal burns with 2-14% total body surface area (TBSA) injury&#xD;
&#xD;
          -  Patients present within 3 days from the time of thermal burn injury&#xD;
&#xD;
          -  Diagnosed by burn surgeon as having deep partial thickness or indeterminate depth burn&#xD;
             (defined as uncertainty between deep second degree or third degree burns)&#xD;
&#xD;
        Aim 2:&#xD;
&#xD;
          -  Thermal burns with ≥20% TBSA&#xD;
&#xD;
        Exclusion Criteria (Aim 3 is included in all criteria):&#xD;
&#xD;
        Aim 1 and 2:&#xD;
&#xD;
          -  Patients with chemical or electrical burns&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Patient/legal guardian/or next of kin unable to consent&#xD;
&#xD;
        Aim 1:&#xD;
&#xD;
          -  Immunosuppressed&#xD;
&#xD;
          -  Taking immune modifying medications&#xD;
&#xD;
          -  Patients requiring &gt;72 hrs. hospital stay&#xD;
&#xD;
          -  Harmonic Ultrasound &amp; Doppler Imaging (HUSD) will be used to exclude burn wounds with&#xD;
             thrombosed vessels at initial presentation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gayle M Gordillo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital East</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davis Heart and Lung Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University/Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martha Morehouse Medical Plaza 2050 Kenny Road</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>February 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>December 13, 2021</last_update_submitted>
  <last_update_submitted_qc>December 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Gayle Gordillo</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Biofilm</keyword>
  <keyword>Procellera</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03248154
org study id: 16-00244
nct id: NCT03248154
lead sponsor: 
collaborator: 
The objective of the study is to analyze the different implications (such as graft loss and
      conversion of indeterminate depth burns) of biofilm infections in burn patients.
      Additionally, it also aims at comparing children's resistance to biofilm infection at wound
      site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.
Subjects will be recruited from three different age groups: 2-18 years old, 18-49 years old,
      and ≥ 50 years old. 150 patients will be enrolled in each age group for arms 1 and 2. Arm 3
      consists of all patients enrolled in the study and involves drawing whole blood for analyzing
      cytokine response. Subjects will have at day 0, 3, 7, 14, 21, 28 +/- 2 days (as applicable
      until graft surgery occurs).At each study visit the following will be collected: burn wound
      data [Lund-Brower Chart, TBSA burn size, date of onset, length, width, area, depth of burn
      injury (as applicable), Standard of Care (SoC) treatment for burn] will be recorded, SoC labs
      since the onset of the burn wounds will be recorded (CBC w/ diff and glucose as applicable),
      digital imaging of the burn injury(s), Laser Doppler Imaging (LDI) will also be perfomed.
      Biopsies will be collected depending on the size of injury (4 from 2cm² burn size, to 10 from
      >8cm² burn size). Blister fluid will be collected by draining the fluid with a needle and
      syringe.Subjects in arm 2 will receive their Standard of Care (SoC) dressing prescribed by
      their provider or will receive the study dressing, 4x4 Procellera that will be applied to a
      specific area of the burn injury.

      2 weeks after the grafting surgery, subjects will return for study visits at day 14, 21, 28
      post-grafting where the following activities will be completed - burn wound data and
      medication review, digital image of the burn injury(s), LDI imaging, HUSD imaging,
      trans-epidermal water loss (TEWL) measurement. Whole blood will be collected.

      Each subjects' medical chart will be followed for 3 months post completion of the study to
      identify patient outcomes (i.e. wound closure data, infection status/type, treatment status,
      surgical outcomes/complications - graft loss, patient death as applicable).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Detection of biofilm infection in burns
time frame: 4 weeks
description: Tissue biopsies will be tested for presence of bacteria using SEM and culture.
measure: Assessing graft loss as a result of biofilm infection
time frame: 4 weeks post grafting surgery
description: TEWL measurement (g/square meter/h) as an indicator of lost barrier function
measure: Burn depth measurement
time frame: 4 weeks
description: Harmonic Ultrasound & Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit
measure: Examining children vs adults for biofilm resistance
time frame: 2 weeks post grafting surgery
description: TNF-a measurement through cytokine assay (pg/ml)
arm group label: Immunocompetent with 2-14% TBSA
arm group type: No Intervention
description: Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness?
arm group label: Immunocompromised with >=20% TBSA
arm group type: Experimental
description: Immunocompromised patients with large thermal burn >=20% TBSA. Higher bacterial burden with biofilm infection will result in higher rates of graft loss. Does application of a wireless electroceutical dressing (Procellera) lower biofilm burden compared to burn subjects receiving standard of care therapy?
arm group label: Peripheral blood - all subjects
arm group type: No Intervention
description: All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection?
intervention type: Device
intervention name: Procellera
description: burn dressing
arm group label: Immunocompromised with >=20% TBSA
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Gayle M Gordillo, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Gayle Gordillo
investigator title: Associate Professor
mesh term: Burns
sharing ipd: No