<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/NCT04502914</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #: L20-067</org_study_id>
    <nct_id>NCT04502914</nct_id>
  </id_info>
  <brief_title>The Study on Bacterial Load Following Open-to-air Management in Burn Patients.</brief_title>
  <official_title>The Study on Bacterial Load Following Open-to-air Management in Burn Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burns are one of the common forms of trauma and are a cause of unintentional death and&#xD;
      injury. Management of burns becomes complex due to multiple associated complications, for&#xD;
      instance, secondary infection of burn wounds is the most common complication associated with&#xD;
      burn injuries. Treatment of bacterial infections with antibiotics is becoming more&#xD;
      challenging due to the development of multidrug-resistance. Hence, there is a critical need&#xD;
      to investigate and establish non-antibiotic approaches to prevent colonization, control&#xD;
      growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial&#xD;
      effects of open-to-air strategies on wound healing. Based on the evidence, the investigators&#xD;
      hypothesize that bacterial load in burn wounds will be lowered when treated with an&#xD;
      open-to-air strategy compared to the traditional closed wound approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Burns are one of the common forms of trauma and are a cause of unintentional death and injury&#xD;
      in the world as well as in the United States (US). Management of burns becomes complex due to&#xD;
      multiple associated complications, which result in short-term and long-term disability.&#xD;
      Secondary infection of burn wounds is the most common complication associated with burn&#xD;
      injuries. Approximately 10,000 people die in the US due to burn-related infections. For&#xD;
      instance, gram-negative Pseudomonas aeruginosa is an opportunistic organism commonly found in&#xD;
      burn wounds. Bacterial infections cause prolonged hospital stay, increase morbidity, and&#xD;
      mortality of burn patients. Treatment of bacterial infections with antibiotics is becoming&#xD;
      more challenging due to the development of multidrug-resistance. Hence, current antibiotic&#xD;
      regimens and wound care are not always successful in eliminating bacterial infections. As&#xD;
      such, there is a critical need to investigate and establish non-antibiotic approaches to&#xD;
      prevent colonization, control growth, and eliminate bacteria from burn wounds.&#xD;
&#xD;
      Recent studies have explored the beneficial effects of open-to-air strategies on wound&#xD;
      healing, especially in the presence of necrotizing infections. In an open-to air strategy,&#xD;
      the wound is left open to the external environment with a heat lamp placed at 6 feet to&#xD;
      promote drying. However, the spritz of a topical solution will be applied to avoid excessive&#xD;
      drying. Based on current evidence, the investigators hypothesize that bacterial load in burn&#xD;
      wounds will be lowered when treated with an open-to-air strategy compared to the traditional&#xD;
      closed wound approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of subjects enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 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>
    <intervention_model_description>The experimental group will consist of wounds treated with the open-to-air strategy. The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The bacterial load at baseline for each treatment</measure>
    <time_frame>At baseline</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained at baseline (i.e., the 0-time point before implementing any the tested wound care management option) from both wound sites of each patient.&#xD;
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The bacterial load on day 1 for each treatment</measure>
    <time_frame>On day 1</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained on day 1 (about 24 hours after obtaining samples for baseline measurement) from both wound sites of each patient.&#xD;
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The bacterial load on day 2 for each treatment</measure>
    <time_frame>On day 2</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained on day 2 (about 48 hours after obtaining samples for baseline measurement) from both wound sites of each patient.&#xD;
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in change in bacterial load for day 1</measure>
    <time_frame>Change in bacterial load from baseline and day 1</time_frame>
    <description>Change in bacterial load from baseline and day 1 and compared between treatment and control groups.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in change in bacterial load for day 2</measure>
    <time_frame>Change in bacterial load from baseline and day 2</time_frame>
    <description>Change in bacterial load from baseline and day 2 and compared between treatment and control groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of bacterial species at baseline for each treatment</measure>
    <time_frame>At baseline</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained at baseline from both wound sites of each patient.&#xD;
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of bacterial species on day 1 for each treatment</measure>
    <time_frame>On day 1</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained at baseline on day 1 from both wound sites of each patient.&#xD;
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of bacterial species on day 1 for each treatment</measure>
    <time_frame>On day 2</time_frame>
    <description>Scrapings of the superficial wound exudate and debris will be obtained on day 2 from both wound sites of each patient.&#xD;
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Burns</condition>
  <condition>Infection Wound</condition>
  <condition>Bacterial Infections</condition>
  <arm_group>
    <arm_group_label>The experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will consist of wounds treated with the open-to-air strategy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open-to-air strategy</intervention_name>
    <description>In open-to-air management, the wound will be washed with a chlorhexidine solution and leave the wound open, or portion of the wound assigned to OTA, to the environment. An electric heat lamp (model no. 53103, 250W, Brandt Industries LLC, Bronx, NY) will be placed at as close to 1 yard (0.91 m) as possible from the wound after daily wound care for 24 hours (+/- 6 hours) to promote drying. However, to prevent excessive drying an hourly spritz of topical solution, e.g., DuoDERM® Hydroactive® gel (ConvaTec Oklahoma City, OK) will be used at the bedside.</description>
    <arm_group_label>The experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional closed-wound management</intervention_name>
    <description>In traditional closed-wound management, once a day the wound will be washed with a chlorhexidine solution and closed with a non-adherent dressing such as ADAPTIC® (Acelity, San Antonio, TX) soaked in topical antimicrobial solutions, ointments, and creams designed to promote wound healing.</description>
    <arm_group_label>The control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 89&#xD;
&#xD;
          2. Burn patients with TBSA≥ 20%&#xD;
&#xD;
          3. Any suspicion of skin colonization or infection based on a positive result of&#xD;
             microbiologic testing. Testing would only be performed if the attending surgeon&#xD;
             treating the patient had a clinical suspicion of wound infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Children&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Yang D, Davies A, Burge B, Watkins P, Dissanaike S. Open-to-Air Is a Viable Option for Initial Wound Care in Necrotizing Soft Tissue Infection that Allows Early Detection of Recurrence without Need for Painful Dressing Changes or Return to Operating Room. Surg Infect (Larchmt). 2018 Jan;19(1):65-70. doi: 10.1089/sur.2017.080. Epub 2017 Dec 6.</citation>
    <PMID>29211657</PMID>
  </results_reference>
  <results_reference>
    <citation>Dai T, Gupta A, Huang YY, Yin R, Murray CK, Vrahas MS, Sherwood ME, Tegos GP, Hamblin MR. Blue light rescues mice from potentially fatal Pseudomonas aeruginosa burn infection: efficacy, safety, and mechanism of action. Antimicrob Agents Chemother. 2013 Mar;57(3):1238-45. doi: 10.1128/AAC.01652-12. Epub 2012 Dec 21.</citation>
    <PMID>23262998</PMID>
  </results_reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
    <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/NCT04502914
org study id: IRB #: L20-067
nct id: NCT04502914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Burns are one of the common forms of trauma and are a cause of unintentional death and
      injury. Management of burns becomes complex due to multiple associated complications, for
      instance, secondary infection of burn wounds is the most common complication associated with
      burn injuries. Treatment of bacterial infections with antibiotics is becoming more
      challenging due to the development of multidrug-resistance. Hence, there is a critical need
      to investigate and establish non-antibiotic approaches to prevent colonization, control
      growth, and eliminate bacteria from burn wounds. Recent studies have explored the beneficial
      effects of open-to-air strategies on wound healing. Based on the evidence, the investigators
      hypothesize that bacterial load in burn wounds will be lowered when treated with an
      open-to-air strategy compared to the traditional closed wound approach.
Burns are one of the common forms of trauma and are a cause of unintentional death and injury
      in the world as well as in the United States (US). Management of burns becomes complex due to
      multiple associated complications, which result in short-term and long-term disability.
      Secondary infection of burn wounds is the most common complication associated with burn
      injuries. Approximately 10,000 people die in the US due to burn-related infections. For
      instance, gram-negative Pseudomonas aeruginosa is an opportunistic organism commonly found in
      burn wounds. Bacterial infections cause prolonged hospital stay, increase morbidity, and
      mortality of burn patients. Treatment of bacterial infections with antibiotics is becoming
      more challenging due to the development of multidrug-resistance. Hence, current antibiotic
      regimens and wound care are not always successful in eliminating bacterial infections. As
      such, there is a critical need to investigate and establish non-antibiotic approaches to
      prevent colonization, control growth, and eliminate bacteria from burn wounds.

      Recent studies have explored the beneficial effects of open-to-air strategies on wound
      healing, especially in the presence of necrotizing infections. In an open-to air strategy,
      the wound is left open to the external environment with a heat lamp placed at 6 feet to
      promote drying. However, the spritz of a topical solution will be applied to avoid excessive
      drying. Based on current evidence, the investigators hypothesize that bacterial load in burn
      wounds will be lowered when treated with an open-to-air strategy compared to the traditional
      closed wound approach.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The experimental group will consist of wounds treated with the open-to-air strategy. The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.
primary purpose: Treatment
masking: None (Open Label)
measure: The bacterial load at baseline for each treatment
time frame: At baseline
description: Scrapings of the superficial wound exudate and debris will be obtained at baseline (i.e., the 0-time point before implementing any the tested wound care management option) from both wound sites of each patient.
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
measure: The bacterial load on day 1 for each treatment
time frame: On day 1
description: Scrapings of the superficial wound exudate and debris will be obtained on day 1 (about 24 hours after obtaining samples for baseline measurement) from both wound sites of each patient.
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
measure: The bacterial load on day 2 for each treatment
time frame: On day 2
description: Scrapings of the superficial wound exudate and debris will be obtained on day 2 (about 48 hours after obtaining samples for baseline measurement) from both wound sites of each patient.
The colony-forming units (CFUs) will be enumerated and CFUs/g will be calculated for treatment and control.
measure: Difference in change in bacterial load for day 1
time frame: Change in bacterial load from baseline and day 1
description: Change in bacterial load from baseline and day 1 and compared between treatment and control groups.
measure: Difference in change in bacterial load for day 2
time frame: Change in bacterial load from baseline and day 2
description: Change in bacterial load from baseline and day 2 and compared between treatment and control groups.
measure: Prevalence of bacterial species at baseline for each treatment
time frame: At baseline
description: Scrapings of the superficial wound exudate and debris will be obtained at baseline from both wound sites of each patient.
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.
measure: Prevalence of bacterial species on day 1 for each treatment
time frame: On day 1
description: Scrapings of the superficial wound exudate and debris will be obtained at baseline on day 1 from both wound sites of each patient.
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.
measure: Prevalence of bacterial species on day 1 for each treatment
time frame: On day 2
description: Scrapings of the superficial wound exudate and debris will be obtained on day 2 from both wound sites of each patient.
Debridement samples will be homogenized and serially diluted.The dilutions will be spot plated on selective agar.
arm group label: The experimental group
arm group type: Experimental
description: The experimental group will consist of wounds treated with the open-to-air strategy.
arm group label: The control group
arm group type: Other
description: The control group will consist of wounds treated with traditional closed-wound management with dressings soaked in topical antimicrobial solutions.
intervention type: Procedure
intervention name: Open-to-air strategy
description: In open-to-air management, the wound will be washed with a chlorhexidine solution and leave the wound open, or portion of the wound assigned to OTA, to the environment. An electric heat lamp (model no. 53103, 250W, Brandt Industries LLC, Bronx, NY) will be placed at as close to 1 yard (0.91 m) as possible from the wound after daily wound care for 24 hours (+/- 6 hours) to promote drying. However, to prevent excessive drying an hourly spritz of topical solution, e.g., DuoDERM® Hydroactive® gel (ConvaTec Oklahoma City, OK) will be used at the bedside.
arm group label: The experimental group
intervention type: Procedure
intervention name: Traditional closed-wound management
description: In traditional closed-wound management, once a day the wound will be washed with a chlorhexidine solution and closed with a non-adherent dressing such as ADAPTIC® (Acelity, San Antonio, TX) soaked in topical antimicrobial solutions, ointments, and creams designed to promote wound healing.
arm group label: The control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
facility: 
country: United States
citation: Yang D, Davies A, Burge B, Watkins P, Dissanaike S. Open-to-Air Is a Viable Option for Initial Wound Care in Necrotizing Soft Tissue Infection that Allows Early Detection of Recurrence without Need for Painful Dressing Changes or Return to Operating Room. Surg Infect (Larchmt). 2018 Jan;19(1):65-70. doi: 10.1089/sur.2017.080. Epub 2017 Dec 6.
PMID: 29211657
citation: Dai T, Gupta A, Huang YY, Yin R, Murray CK, Vrahas MS, Sherwood ME, Tegos GP, Hamblin MR. Blue light rescues mice from potentially fatal Pseudomonas aeruginosa burn infection: efficacy, safety, and mechanism of action. Antimicrob Agents Chemother. 2013 Mar;57(3):1238-45. doi: 10.1128/AAC.01652-12. Epub 2012 Dec 21.
PMID: 23262998
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Burns
sharing ipd: No