<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/NCT04412759</url>
  </required_header>
  <id_info>
    <org_study_id>MC-2015</org_study_id>
    <nct_id>NCT04412759</nct_id>
  </id_info>
  <brief_title>PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS</brief_title>
  <official_title>PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL 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>
      The purpose of this study was to compare two wound dressing products for partial thickness&#xD;
      burns in adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study, all patients that had given written informed consent&#xD;
      underwent screening. If eligible study participants were randomized to be treated wih either&#xD;
      the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within&#xD;
      72 hours after burn injury. Evaluation was done in an open manner due to the specific&#xD;
      characteristics of the dressings. Study particpants were followed weekly until complete wound&#xD;
      closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">November 2019</completion_date>
  <primary_completion_date type="Actual">November 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to complete healing of the burn</measure>
    <time_frame>Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months</time_frame>
    <description>Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Burn wound infection</measure>
    <time_frame>Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months</time_frame>
    <description>Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria:&#xD;
(based on the American Burn Association definition of burn wound infection)&#xD;
Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site.&#xD;
Positive bacterial culture growth of the surface wound swab.&#xD;
Signs of systemic infection indicated by a rise in CRP concentration (reference range &lt; 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burn wound pain</measure>
    <time_frame>Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months</time_frame>
    <description>The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay (LOS)</measure>
    <time_frame>From admission until discharge, up to 6 months</time_frame>
    <description>All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burn scar outcome</measure>
    <time_frame>Evaluated at six and 12 months after injury</time_frame>
    <description>Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Burns</condition>
  <condition>Burn Scar</condition>
  <condition>Burn Second Degree</condition>
  <arm_group>
    <arm_group_label>Porcine xenograft</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microbial cellulose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>microbial cellulose</intervention_name>
    <description>polymer dressing synthesized in abundance with Acetobacter Xylinum</description>
    <arm_group_label>Microbial cellulose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study participants admitted within 72 hours of injury&#xD;
&#xD;
          -  partial-thickness burns requiring a temporary skin cover&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe coexisting cutaneous trauma&#xD;
&#xD;
          -  chronic or current skin disease,&#xD;
&#xD;
          -  severe cognitive dysfunction or psychiatric disorder&#xD;
&#xD;
          -  pregnant or breast feeding women were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 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 in burn care</investigator_title>
  </responsible_party>
  <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/NCT04412759
org study id: MC-2015
nct id: NCT04412759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study was to compare two wound dressing products for partial thickness
      burns in adults.
After being informed about the study, all patients that had given written informed consent
      underwent screening. If eligible study participants were randomized to be treated wih either
      the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within
      72 hours after burn injury. Evaluation was done in an open manner due to the specific
      characteristics of the dressings. Study particpants were followed weekly until complete wound
      closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to complete healing of the burn
time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
description: Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.
measure: Burn wound infection
time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
description: Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria:
(based on the American Burn Association definition of burn wound infection)
Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site.
Positive bacterial culture growth of the surface wound swab.
Signs of systemic infection indicated by a rise in CRP concentration (reference range < 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded.
measure: Burn wound pain
time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
description: The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable.
measure: Duration of hospital stay (LOS)
time frame: From admission until discharge, up to 6 months
description: All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay.
measure: Burn scar outcome
time frame: Evaluated at six and 12 months after injury
description: Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants.
arm group label: Porcine xenograft
arm group type: No Intervention
description: porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre
arm group label: Microbial cellulose
arm group type: Experimental
description: Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed).
intervention type: Other
intervention name: microbial cellulose
description: polymer dressing synthesized in abundance with Acetobacter Xylinum
arm group label: Microbial cellulose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Linkoeping
investigator full name: Folke Sjoberg
investigator title: Professor in burn care
mesh term: Burns
sharing ipd: No