<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/NCT04410497</url>
  </required_header>
  <id_info>
    <org_study_id>DPS-2014</org_study_id>
    <nct_id>NCT04410497</nct_id>
  </id_info>
  <brief_title>Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds</brief_title>
  <official_title>Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds: A Prospective Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Linkoeping</source>
  <oversight_info>
    <has_dmc>No</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>
      Prospective randomized trial where two dressings has been compared for partial thickness&#xD;
      scald burns in children 6 months to 6 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The aim of this study was to compare two different treatment regimes for children with&#xD;
      partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®,&#xD;
      Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke&#xD;
      Health Care, Gothenburg, Sweden).&#xD;
&#xD;
      Methods: A prospective randomized clinical trial including 58 children admitted between May&#xD;
      2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden.&#xD;
      Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery,&#xD;
      wound infection, length of hospital stay, required dressings changes, and labour time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 11, 2015</start_date>
  <completion_date type="Actual">May 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 8, 2018</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>Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to complete wound closure</measure>
    <time_frame>Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)</time_frame>
    <description>Calculated from the date of injury to the date when the wound bed was assessed as completely reepithelialized with no necessity for further wound dressings other than a protective dressing against shearing, according to both the attending physician and nurse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (at wound site)</measure>
    <time_frame>Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>Pain is to evaluated by staff before, during and after wound dressing Changes using the Face, Legs, Activity, Cry, Consolability, behavioural pain scale (FLACC) is a five-category behavioral instrument where each category is scored on a scale of 0-2, resulting in a result between 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need of surgery</measure>
    <time_frame>Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>Evaluated as yes or no (surgery perfomered according to the medical record)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burn wound infection</measure>
    <time_frame>Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>Children were diagnosed with burn wound infection by the burn surgeon and a consultant physician specialized in infectious diseases if fulfilling at least two of the following criteria based on American Burn Association definition of burn wound infection&#xD;
Clinical signs such as localised pain and swelling, spreading erythema (redness), and heat at the affected site.&#xD;
Surface wound swab culture presenting a minimum of 106 colony-forming units (CFU)/L (equivalent to the ABA definition of 105 CFU/g) [29].&#xD;
Systemic signs of infection indicated as a rise of C-reactive protein (CRP) level (reference range &lt; 10 mg/L for capillary sampling) together with increased body temperature exceeding 38 °C- 48 hours after injury where other sources of infection are excluded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Evaluated after complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>number of days when the child received in hospital care (including readmissions)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of dressing changes required</measure>
    <time_frame>Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>documented in CRF and in medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>any local reaction seen in or around wound during the time when study dressings were used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes needed for application and removal of dressing</measure>
    <time_frame>Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.</time_frame>
    <description>documented in CRF and in medical records</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Burns Scald</condition>
  <arm_group>
    <arm_group_label>Porcine xenograft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silver foam</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Porcine xenograft (wound dressings)</intervention_name>
    <description>commercial porcine xenograft, derived from acellular dermis from porcine.</description>
    <arm_group_label>Porcine xenograft</arm_group_label>
    <other_name>EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Silver foam (wound dressings)</intervention_name>
    <description>commercial silver containing foam dressing</description>
    <arm_group_label>Silver foam</arm_group_label>
    <other_name>Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Partial-thickness scald burns admitted within 72 hours of injury and with burns&#xD;
             suitable for porcine xenograft according to the burn surgeon on duty were eligible and&#xD;
             enrolled after (guardians) consenting to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with other severe concomitant cutaneous trauma, skin disease, or children&#xD;
             with a known hypersensitivity to silver.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johan Thorfinn, Ass.prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoping Burn Centre, University hospital of Linkoping, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Burn Centre at Linköping University Hospital,</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Linkoeping</investigator_affiliation>
    <investigator_full_name>Folke Sjoberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>burns dressings healing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>only if asked for</ipd_description>
  </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/NCT04410497
org study id: DPS-2014
nct id: NCT04410497
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective randomized trial where two dressings has been compared for partial thickness
      scald burns in children 6 months to 6 years.
Aim: The aim of this study was to compare two different treatment regimes for children with
      partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®,
      Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke
      Health Care, Gothenburg, Sweden).

      Methods: A prospective randomized clinical trial including 58 children admitted between May
      2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden.
      Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery,
      wound infection, length of hospital stay, required dressings changes, and labour time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.
primary purpose: Treatment
masking: None (Open Label)
measure: Time to complete wound closure
time frame: Evaluated 2-3 times per week until complete wound closure, approximatley 15-20 days after injury (injury-complete healing)
description: Calculated from the date of injury to the date when the wound bed was assessed as completely reepithelialized with no necessity for further wound dressings other than a protective dressing against shearing, according to both the attending physician and nurse
measure: Pain (at wound site)
time frame: Evaluated before,during and after dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: Pain is to evaluated by staff before, during and after wound dressing Changes using the Face, Legs, Activity, Cry, Consolability, behavioural pain scale (FLACC) is a five-category behavioral instrument where each category is scored on a scale of 0-2, resulting in a result between 0-10
measure: Need of surgery
time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: Evaluated as yes or no (surgery perfomered according to the medical record)
measure: Burn wound infection
time frame: Evaluated at each dressing change; 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: Children were diagnosed with burn wound infection by the burn surgeon and a consultant physician specialized in infectious diseases if fulfilling at least two of the following criteria based on American Burn Association definition of burn wound infection
Clinical signs such as localised pain and swelling, spreading erythema (redness), and heat at the affected site.
Surface wound swab culture presenting a minimum of 106 colony-forming units (CFU)/L (equivalent to the ABA definition of 105 CFU/g) [29].
Systemic signs of infection indicated as a rise of C-reactive protein (CRP) level (reference range < 10 mg/L for capillary sampling) together with increased body temperature exceeding 38 °C- 48 hours after injury where other sources of infection are excluded
measure: Length of hospital stay
time frame: Evaluated after complete wound closure, approximatley 15-20 days after injury.
description: number of days when the child received in hospital care (including readmissions)
measure: number of dressing changes required
time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: documented in CRF and in medical records
measure: adverse events
time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: any local reaction seen in or around wound during the time when study dressings were used
measure: Minutes needed for application and removal of dressing
time frame: Evaluated at dressing changes, performed 2-3 times per week until complete wound closure, approximatley 15-20 days after injury.
description: documented in CRF and in medical records
arm group label: Porcine xenograft
arm group type: Experimental
description: Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care).
arm group label: Silver foam
arm group type: Active Comparator
description: Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise
intervention type: Other
intervention name: Porcine xenograft (wound dressings)
description: commercial porcine xenograft, derived from acellular dermis from porcine.
arm group label: Porcine xenograft
other name: EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden
intervention type: Other
intervention name: Silver foam (wound dressings)
description: commercial silver containing foam dressing
arm group label: Silver foam
other name: Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden
criteria: 
gender: All
minimum age: 6 Months
maximum age: 6 Years
healthy volunteers: No
last name: Johan Thorfinn, Ass.prof.
role: Principal Investigator
affiliation: Linkoping Burn Centre, University hospital of Linkoping, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Folke Sjoberg
investigator title: Professor
sharing ipd: No
ipd description: only if asked for