<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/NCT03040882</url>
  </required_header>
  <id_info>
    <org_study_id>0014868</org_study_id>
    <nct_id>NCT03040882</nct_id>
  </id_info>
  <brief_title>Cotton Sock in Pediatric Patients With Leg-foot Splint</brief_title>
  <official_title>Effectiveness of Cotton Sock in Pediatric Patients With Leg-foot Splint After Surgery for Correction of the Foot, in Reducing the Incidence of Cutaneous Lesions. Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Rizzoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Rizzoli</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 post-operative treatment of pediatric patients operated for the correction of flat foot,&#xD;
      sees today the use of preformed leg-foot splint (Walker) as an alternative to the application&#xD;
      of plaster casts. The change of the immobilization system has led to the appearance of&#xD;
      problems of tolerability in particular in the skin. The problems persist also after placing a&#xD;
      polyurethane foam dress at the heel in the immediate postoperative period. The aim of this&#xD;
      study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in&#xD;
      children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous&#xD;
      lesions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">January 30, 2017</completion_date>
  <primary_completion_date type="Actual">January 30, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heel Pressure Sores</measure>
    <time_frame>every day until discharge (expected average of 3 days).</time_frame>
    <description>• Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>up to the first 3 days post intervention</time_frame>
    <description>Pain Score on the &quot;Numeric Rating Scale&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Flat Foot</condition>
  <arm_group>
    <arm_group_label>cotton sock</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Elastic Compression Wraps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cotton sock</intervention_name>
    <description>Application of a cotton sock in the immediate postoperative period before applied the Walker</description>
    <arm_group_label>cotton sock</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elastic Compression Wraps</intervention_name>
    <description>Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)</description>
    <arm_group_label>Elastic Compression Wraps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged &gt; 3 years&#xD;
&#xD;
          -  Treated for flat foot&#xD;
&#xD;
          -  Children with intact skin at the heel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caregivers who cannot speak Italian&#xD;
&#xD;
          -  Those who refuse to give their consent to take part in the study&#xD;
&#xD;
          -  Patients with lower limb casts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caterina Guerra, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Ortopedico Rizzoli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Flatfoot</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/NCT03040882
org study id: 0014868
nct id: NCT03040882
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The post-operative treatment of pediatric patients operated for the correction of flat foot,
      sees today the use of preformed leg-foot splint (Walker) as an alternative to the application
      of plaster casts. The change of the immobilization system has led to the appearance of
      problems of tolerability in particular in the skin. The problems persist also after placing a
      polyurethane foam dress at the heel in the immediate postoperative period. The aim of this
      study is to evaluate the effectiveness of a cotton sock applied inside the leg-foot splint in
      children operated vs the Elastic Compression Wraps in reducing the incidence of cutaneous
      lesions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Heel Pressure Sores
time frame: every day until discharge (expected average of 3 days).
description: • Numbers of Participants With Heel Pressure Sores of all grade Detected According to the Classification of the Scale of the National Pressure Ulcer Advisory Panel -N.P.U.A.P.
measure: Pain
time frame: up to the first 3 days post intervention
description: Pain Score on the "Numeric Rating Scale"
arm group label: cotton sock
arm group type: Experimental
arm group label: Elastic Compression Wraps
arm group type: Active Comparator
intervention type: Other
intervention name: cotton sock
description: Application of a cotton sock in the immediate postoperative period before applied the Walker
arm group label: cotton sock
intervention type: Other
intervention name: Elastic Compression Wraps
description: Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
arm group label: Elastic Compression Wraps
criteria: 
gender: All
minimum age: 4 Years
maximum age: 18 Years
healthy volunteers: No
last name: Caterina Guerra, RN
role: Principal Investigator
affiliation: Istituto Ortopedico Rizzoli
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Flatfoot
sharing ipd: No