<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/NCT03227146</url>
  </required_header>
  <id_info>
    <org_study_id>TBRU-dS-BA-PIIb</org_study_id>
    <nct_id>NCT03227146</nct_id>
  </id_info>
  <brief_title>Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents</brief_title>
  <official_title>A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CUTISS AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wyss Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Julius Clinical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sintesi Research Srl</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Zürich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CUTISS AG</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>
      This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)&#xD;
      in comparison to meshed STSG in adults and adolescents with partial deep dermal and full&#xD;
      thickness burns.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicentre phase IIb clinical trial will target adults and adolescents with severe&#xD;
      burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the&#xD;
      patient group with the highest mortality rates. Particular emphasis, apart from safety, will&#xD;
      be placed on efficacy, including the ratio of covered surface area to harvested surface area&#xD;
      and scar quality, in comparison to meshed STSG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface</measure>
    <time_frame>4 weeks post grafting</time_frame>
    <description>Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection</measure>
    <time_frame>4-11 days post grafting and 21 +/-2 days post grafting</time_frame>
    <description>Evaluation of clinical signs of infection at experimental area and control area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection</measure>
    <time_frame>4-11 days post grafting and 21 +/-2 days post grafting</time_frame>
    <description>Evaluation of microbiologic signs of infection at experimental area and control area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)</measure>
    <time_frame>1 year +/-30 days post grafting</time_frame>
    <description>Assessment of elasticity of experimental area and control area using Cutometer(R)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of General scar quality using POSAS assessment tool</measure>
    <time_frame>1 year +/-30 days post grafting</time_frame>
    <description>Assessment of general scar Quality of experimental area and control area using POSAS assessment tool</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>EHSG-KF and STSG Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EHSG-KF</intervention_name>
    <description>Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area</description>
    <arm_group_label>EHSG-KF and STSG Transplantation</arm_group_label>
    <other_name>denovoSkin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>STSG</intervention_name>
    <description>Transplantation of autologous split-thickness skin graft to the control area</description>
    <arm_group_label>EHSG-KF and STSG Transplantation</arm_group_label>
    <other_name>Split-thickness skin graft</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: ≥12 years of age&#xD;
&#xD;
          -  Deep partial thickness and/or full thickness burns requiring surgical wound coverage&#xD;
&#xD;
          -  Expected that ≥90 cm2 of wound (not counting the head and neck area for study patients&#xD;
             in The Netherlands) will remain open at 4 weeks post burn despite proceeding with&#xD;
             treatment in accordance with the standard of care. &gt;20% TBSA burns can be taken as&#xD;
             guideline, but TBSA is not an inclusion criterion.&#xD;
&#xD;
          -  Signed Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients tested positive for HBV, HCV, syphilis or HIV&#xD;
&#xD;
          -  Patients with known underlying or concomitant medical conditions that may interfere&#xD;
             with normal wound healing (e.g. systemic skin and connective tissue diseases, any kind&#xD;
             of congenital defect of metabolism including insulin-dependent diabetes mellitus,&#xD;
             Cushing syndrome or disease, scurvy, chronic hypothyroidism, congenital or acquired&#xD;
             immunosuppressive condition, chronic renal failure, or chronic hepatic dysfunction&#xD;
             (Child-Pugh class B or C), severe malnutrition, or other concomitant illness which, in&#xD;
             the opinion of the Investigator, has the potential to significantly delay wound&#xD;
             healing)&#xD;
&#xD;
          -  Severe drug and alcohol abuse&#xD;
&#xD;
          -  Pre-existing coagulation disorders as defined by INR outside its normal value, PTT&#xD;
             &gt;ULN and fibrinogen &lt;LLN prior to the current hospital admission and / or at the&#xD;
             Investigator's discretion&#xD;
&#xD;
          -  Patients with known allergies to amphotericin B, gentamicin, penicillin, streptomycin,&#xD;
             or bovine collagen&#xD;
&#xD;
          -  Previous enrolment of the patient into the current phase II study&#xD;
&#xD;
          -  Participation of the patient in another study with conflicting endpoints within 30&#xD;
             days preceding and during the present study&#xD;
&#xD;
          -  Patients expected not to comply with the study protocol (including patients with&#xD;
             severe cognitive dysfunction/impairment and severe psychiatric disorders)&#xD;
&#xD;
          -  Pregnant or breast feeding females&#xD;
&#xD;
          -  Intention to become pregnant during the clinical course of the study (12 months)&#xD;
&#xD;
          -  Wounds in the head and neck area as study target area (only applicable for study&#xD;
             patients in The Netherlands)&#xD;
&#xD;
          -  Enrolment of the Investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clemens Schiestl, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>University Children's Hospital, Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unità di Chirurgia Plastica e Ustioni Ospedale Santobono</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O.C. Grandi Ustionati Azienda Ospedale Università Padova</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Città della Salute</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Chirurgia Plastica e Centro Ustioni Azienda Ospedaliera Universitaria Integrata Verona</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rode Kruis Ziekenhuis</name>
      <address>
        <city>Beverwijk</city>
        <zip>1940</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstad Ziekenhuis</name>
      <address>
        <city>Rotterdam</city>
        <zip>3079</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Burns</keyword>
  <keyword>Scar</keyword>
  <keyword>Skin</keyword>
  <keyword>Wound healing</keyword>
  <keyword>Tissue Engineering</keyword>
  <keyword>Dermis</keyword>
  <keyword>Epidermis</keyword>
  <keyword>Thermal Injuries</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/NCT03227146
org study id: TBRU-dS-BA-PIIb
nct id: NCT03227146
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin)
      in comparison to meshed STSG in adults and adolescents with partial deep dermal and full
      thickness burns.
This multicentre phase IIb clinical trial will target adults and adolescents with severe
      burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the
      patient group with the highest mortality rates. Particular emphasis, apart from safety, will
      be placed on efficacy, including the ratio of covered surface area to harvested surface area
      and scar quality, in comparison to meshed STSG.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface
time frame: 4 weeks post grafting
description: Efficacy of EHSG-KF in comparison to meshed STSG based on ratio of covered surface area to biopsy site/donor site surface area
measure: Safety of EHSG-KF in comparison to meshed STSG based on clinical signs of infection
time frame: 4-11 days post grafting and 21 +/-2 days post grafting
description: Evaluation of clinical signs of infection at experimental area and control area
measure: Safety of EHSG-KF in comparison to meshed STSG based on microbiological signs of infection
time frame: 4-11 days post grafting and 21 +/-2 days post grafting
description: Evaluation of microbiologic signs of infection at experimental area and control area
measure: Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by measurement of the elasticity using Cutometer(R)
time frame: 1 year +/-30 days post grafting
description: Assessment of elasticity of experimental area and control area using Cutometer(R)
measure: Efficacy of EHSG-KF in comparison to meshed STSG based on evaluation of scar quality by assessment of General scar quality using POSAS assessment tool
time frame: 1 year +/-30 days post grafting
description: Assessment of general scar Quality of experimental area and control area using POSAS assessment tool
arm group label: EHSG-KF and STSG Transplantation
arm group type: Experimental
description: Transplantation of EHSG-KF to the experimental area and transplantation of STSG (split-thickness skin graft) to the control area
intervention type: Biological
intervention name: EHSG-KF
description: Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
arm group label: EHSG-KF and STSG Transplantation
other name: denovoSkin
intervention type: Biological
intervention name: STSG
description: Transplantation of autologous split-thickness skin graft to the control area
arm group label: EHSG-KF and STSG Transplantation
other name: Split-thickness skin graft
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Clemens Schiestl, Prof.
role: Study Chair
affiliation: University Children's Hospital, Zurich
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: Netherlands
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Burns
sharing ipd: No