xml: <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/NCT05977595</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0747</org_study_id>
      <nct_id>NCT05977595</nct_id>
    </id_info>
    <brief_title>Cosmetic and Functional Sequelae in Hand Burns.</brief_title>
    <acronym>AdipoSCAR</acronym>
    <official_title>A Descriptive Study of the Cosmetic and Functional Sequelae of Patients Who Received Releasing Incisions in the Management of Acute Upper Limb Burns.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Although it represents a small percentage of the body surface, the hand is the most exposed&#xD;
        part of the body after the face and neck and is one of the area's most frequently involved in&#xD;
        burns. It has a social function, but above all, a functionnal one. An optimized&#xD;
        reconstruction of this area after the burn allow the patient to recover the best possible&#xD;
        function and increase his chances of returning to professional activity and daily life.&#xD;
        Advances in burn treatment, such as improved resuscitation management, rapid excision of&#xD;
        burns, skin grafting, regular dressings, and improved metabolic support, have reduced the&#xD;
        morbidity and mortality of severe burns. However, significant challenges remain.&#xD;
  &#xD;
        The hand is the most frequently involved area in burns and is affected in 90% of severe&#xD;
        burns. Hand burns requiring releasing incisions are circular, deep burns and represent a&#xD;
        significant functional challenge. In the acute setting, current treatment options must&#xD;
        prevent complications associated with disruption of the skin's protective function. In the&#xD;
        longer term, these treatments should allow the regeneration of fully functional skin.&#xD;
        However, some sequelae may persist in the form of sensory deficits, residual pain, retractile&#xD;
        scars hindering function in this highly mobile area, or even aesthetic sequelae.&#xD;
  &#xD;
        The aim of our study was to perform a descriptive analysis of the aesthetic and functional&#xD;
        sequelae related to hand burns that required acute realeasing incisions using objective and&#xD;
        subjective tools available in the medical records (demographic, clinical and follow-up data&#xD;
        in the context of routine care). This retrospective, non-interventional, data-driven study&#xD;
        would provide an overview of the sequelae of hand burns with current therapies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Functional score</measure>
      <time_frame>Through the completion of study, average 6 months</time_frame>
      <description>Functional recovery at 3 months and 6 months after the burn (functional score, return to activities) Healing time (discontinuation of dressings). Scar quality (hypertrophic, retractile, surgical revision necessary and surgery of sequela).&#xD;
  Burn VAS (1-10) at 3 and 6 months. QuickDASH Score at 3 and 6 months. Scar quality at 6 months. Burn VAS at 3 months and 6 months.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Healing assessment</measure>
      <time_frame>Through the completion of study, average 6 months</time_frame>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hand Burn</condition>
    <arm_group>
      <arm_group_label>Deep hand burns</arm_group_label>
      <description>Adult subjects, who were hospitalized at the Pierre Colson Burn Center with a hand burn that required releasing incisions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries</intervention_name>
      <description>Functional and aesthetic criteria : Quick DASH Score at 3 month and 6 months, Visual Analog Scale at 3 month and 6 months, scar quality (assessment by surgeon), healing (discontinuation of dressings), need for a second surgical procedure.</description>
      <arm_group_label>Deep hand burns</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult subjects, who were hospitalized at the Pierre Colson Burn Center (University&#xD;
          Hospital) with a hand burn that required discharge incisions between January 2019 and June&#xD;
          2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria :&#xD;
  &#xD;
                 -  Adult patients&#xD;
  &#xD;
                 -  Acute burn (less than 3 days)&#xD;
  &#xD;
                 -  Burns of one or both hands or finger burns&#xD;
  &#xD;
                 -  Skin surface burned less than 40% of the body&#xD;
  &#xD;
                 -  Chemical, thermal, or electrical burns of the hand.&#xD;
  &#xD;
                 -  Burn that required a skin graft.&#xD;
  &#xD;
            -  Exclusion Criteria :&#xD;
  &#xD;
                 -  Patient refusal&#xD;
  &#xD;
                 -  Less than 1 month follow-up or death within the first month&#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>Edouard Herriot University hospital</name>
        <address>
          <city>Lyon</city>
          <zip>69003</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Camille BRENAC, Dr</last_name>
        <phone>679992181</phone>
        <phone_ext>+33</phone_ext>
        <email>camille.brenac@chu-lyon.fr</email>
      </contact>
      <contact_backup>
        <last_name>Alain Ali MOJALLAL, Dr</last_name>
        <phone>426732822</phone>
        <phone_ext>+33</phone_ext>
        <email>alain-ali.mojallal@chu-lyon.fr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>burns</keyword>
    <keyword>hands</keyword>
    <keyword>functional outcomes</keyword>
    <keyword>skin graft</keyword>
    <keyword>releasing incisions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burns</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977595
  org study id: 69HCL23_0747
  nct id: NCT05977595
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although it represents a small percentage of the body surface, the hand is the most exposed
        part of the body after the face and neck and is one of the area's most frequently involved in
        burns. It has a social function, but above all, a functionnal one. An optimized
        reconstruction of this area after the burn allow the patient to recover the best possible
        function and increase his chances of returning to professional activity and daily life.
        Advances in burn treatment, such as improved resuscitation management, rapid excision of
        burns, skin grafting, regular dressings, and improved metabolic support, have reduced the
        morbidity and mortality of severe burns. However, significant challenges remain.
  
        The hand is the most frequently involved area in burns and is affected in 90% of severe
        burns. Hand burns requiring releasing incisions are circular, deep burns and represent a
        significant functional challenge. In the acute setting, current treatment options must
        prevent complications associated with disruption of the skin's protective function. In the
        longer term, these treatments should allow the regeneration of fully functional skin.
        However, some sequelae may persist in the form of sensory deficits, residual pain, retractile
        scars hindering function in this highly mobile area, or even aesthetic sequelae.
  
        The aim of our study was to perform a descriptive analysis of the aesthetic and functional
        sequelae related to hand burns that required acute realeasing incisions using objective and
        subjective tools available in the medical records (demographic, clinical and follow-up data
        in the context of routine care). This retrospective, non-interventional, data-driven study
        would provide an overview of the sequelae of hand burns with current therapies.
  observational model: Cohort
  time perspective: Retrospective
  measure: Functional score
  time frame: Through the completion of study, average 6 months
  description: Functional recovery at 3 months and 6 months after the burn (functional score, return to activities) Healing time (discontinuation of dressings). Scar quality (hypertrophic, retractile, surgical revision necessary and surgery of sequela).
  Burn VAS (1-10) at 3 and 6 months. QuickDASH Score at 3 and 6 months. Scar quality at 6 months. Burn VAS at 3 months and 6 months.
  measure: Healing assessment
  time frame: Through the completion of study, average 6 months
  arm group label: Deep hand burns
  description: Adult subjects, who were hospitalized at the Pierre Colson Burn Center with a hand burn that required releasing incisions.
  intervention type: Other
  intervention name: Quick DASH Score Visual Analog Scale Scar quality Healing Number of surgeries
  description: Functional and aesthetic criteria : Quick DASH Score at 3 month and 6 months, Visual Analog Scale at 3 month and 6 months, scar quality (assessment by surgeon), healing (discontinuation of dressings), need for a second surgical procedure.
  arm group label: Deep hand burns
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Burns