<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/NCT03279549</url>
  </required_header>
  <id_info>
    <org_study_id>KY20140709-1</org_study_id>
    <nct_id>NCT03279549</nct_id>
  </id_info>
  <brief_title>Research on the Key Technology of Burn Wound Treatment</brief_title>
  <official_title>A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xijing Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Jishuitan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Hospitals affiliated to the China PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xijing Hospital</source>
  <oversight_info>
    <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 common injuries in the daily life and wars. With the development of medical&#xD;
      techniques, the mortality has been significantly reduced. However, the deformity and&#xD;
      disability caused by hypertrophic scar have not been improved effectively since the wound&#xD;
      repair technology is limited and controversial, especially on the early treatment of deep&#xD;
      second degree burns. The prognosis of burns is of great difference. In recent years, the&#xD;
      promotion of wound repairing technologies provides a new opportunity for improving the&#xD;
      quality of wound healing and solving the problem of scar formation. Although some new methods&#xD;
      and techniques have shown significant efficacy in clinic, clinical researches with large&#xD;
      samples conducted in multiple centers are still deficient, impeding the evaluation of their&#xD;
      superiority. Therefore, the current protocol focuses on the repair of deep second degree&#xD;
      burns based on previous researches. There are four types of treatment protocols for wounds.&#xD;
      Patients were divided into four groups randomly, including regular dressing change group,&#xD;
      controlled debridement + biological dressing covering group (xenogeneic acellular dermal&#xD;
      matrix), controlled debridement + epidermal cell cultivation group, controlled debridement +&#xD;
      bFGF treatment group. The wound healing rate, healing time and scar formation were observed.&#xD;
      The availability and security were evaluated. Further more, treatment guidelines and expert&#xD;
      consensuses on deep second degree burn wounds were concluded. Above studies are important to&#xD;
      promote the treatment of deep second degree burns to be scientific, standardized and&#xD;
      professional in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 1, 2018</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Wound healing time</measure>
    <time_frame>21 days after treatment</time_frame>
    <description>Healing time is the number of days when the wound healed completely after management.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing rate</measure>
    <time_frame>21 days after treatment</time_frame>
    <description>Wound healing rate =（area before management - area after management）/ area before management×100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scar formation</measure>
    <time_frame>6 months after treatment</time_frame>
    <description>Vancouver scar score</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Burn</condition>
  <arm_group>
    <arm_group_label>dressing change group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine dressing change group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dermal matrix dressing group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Limited debridement &amp; Acellular dermal matrix dressing group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epidermal cell spraying group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Limited debridement &amp; Epidermal cell spraying group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BFGF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Limited debridement &amp; Basic fibroblast growth factor group</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Routine dressing change</intervention_name>
    <description>Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.</description>
    <arm_group_label>dressing change group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limited debridement &amp; Acellular dermal matrix dressing</intervention_name>
    <description>In the removal of necrotic dermis in the &quot;rather not deep&quot; principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.</description>
    <arm_group_label>Dermal matrix dressing group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limited debridement &amp; Epidermal cell spraying</intervention_name>
    <description>In the removal of necrotic dermis in the &quot;rather not deep&quot; principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site.</description>
    <arm_group_label>Epidermal cell spraying group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limited debridement &amp; Basic fibroblast growth factor</intervention_name>
    <description>In the removal of necrotic dermis in the &quot;rather not deep&quot; principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds.</description>
    <arm_group_label>BFGF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Area of deep second burn wound &gt;=10cm×10cm，total burn area ≤50% TBSA.&#xD;
&#xD;
          2. Within 96 hours after burns and could be managed within 24 hours after included.&#xD;
&#xD;
          3. Ages from 18 to 60.&#xD;
&#xD;
          4. No serious breathing, circulation and other systemic diseases, no surgical&#xD;
             contraindications.&#xD;
&#xD;
          5. Agrees to participate in this trial and has signed an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have severe inhalation injury or shock, or acute respiratory failure；&#xD;
&#xD;
          2. There are serious heart (especially the recent myocardial infarction, myocardial&#xD;
             damage, etc.), brain, liver, kidney, lung and other organ disease;&#xD;
&#xD;
          3. Susceptible to allergies；&#xD;
&#xD;
          4. Islamic believers&#xD;
&#xD;
          5. Pregnant women&#xD;
&#xD;
          6. Other cases that are not suitable for study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xie Songtao, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xijing Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hu Dahai, Doctor</last_name>
    <phone>029-84775293</phone>
    <email>hudhai@fmmu.edu.cn</email>
  </overall_contact>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xijing Hospital</investigator_affiliation>
    <investigator_full_name>Hu Dahai</investigator_full_name>
    <investigator_title>Director of Burn Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
  </intervention_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/NCT03279549
org study id: KY20140709-1
nct id: NCT03279549
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Burns are common injuries in the daily life and wars. With the development of medical
      techniques, the mortality has been significantly reduced. However, the deformity and
      disability caused by hypertrophic scar have not been improved effectively since the wound
      repair technology is limited and controversial, especially on the early treatment of deep
      second degree burns. The prognosis of burns is of great difference. In recent years, the
      promotion of wound repairing technologies provides a new opportunity for improving the
      quality of wound healing and solving the problem of scar formation. Although some new methods
      and techniques have shown significant efficacy in clinic, clinical researches with large
      samples conducted in multiple centers are still deficient, impeding the evaluation of their
      superiority. Therefore, the current protocol focuses on the repair of deep second degree
      burns based on previous researches. There are four types of treatment protocols for wounds.
      Patients were divided into four groups randomly, including regular dressing change group,
      controlled debridement + biological dressing covering group (xenogeneic acellular dermal
      matrix), controlled debridement + epidermal cell cultivation group, controlled debridement +
      bFGF treatment group. The wound healing rate, healing time and scar formation were observed.
      The availability and security were evaluated. Further more, treatment guidelines and expert
      consensuses on deep second degree burn wounds were concluded. Above studies are important to
      promote the treatment of deep second degree burns to be scientific, standardized and
      professional in China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Wound healing time
time frame: 21 days after treatment
description: Healing time is the number of days when the wound healed completely after management.
measure: Wound healing rate
time frame: 21 days after treatment
description: Wound healing rate =（area before management - area after management）/ area before management×100%.
measure: Scar formation
time frame: 6 months after treatment
description: Vancouver scar score
arm group label: dressing change group
arm group type: Active Comparator
description: Routine dressing change group
arm group label: Dermal matrix dressing group
arm group type: Experimental
description: Limited debridement & Acellular dermal matrix dressing group.
arm group label: Epidermal cell spraying group
arm group type: Experimental
description: Limited debridement & Epidermal cell spraying group
arm group label: BFGF group
arm group type: Experimental
description: Limited debridement & Basic fibroblast growth factor group
intervention type: Procedure
intervention name: Routine dressing change
description: Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.
arm group label: dressing change group
intervention type: Procedure
intervention name: Limited debridement & Acellular dermal matrix dressing
description: In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.
arm group label: Dermal matrix dressing group
intervention type: Procedure
intervention name: Limited debridement & Epidermal cell spraying
description: In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site.
arm group label: Epidermal cell spraying group
intervention type: Procedure
intervention name: Limited debridement & Basic fibroblast growth factor
description: In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds.
arm group label: BFGF group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xie Songtao, Doctor
role: Principal Investigator
affiliation: Xijing Hospital
last name: Hu Dahai, Doctor
phone: 029-84775293
email: hudhai@fmmu.edu.cn
responsible party type: Principal Investigator
investigator affiliation: Xijing Hospital
investigator full name: Hu Dahai
investigator title: Director of Burn Center
mesh term: Burns
mesh term: Mitogens
sharing ipd: No