<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/NCT03039179</url>
  </required_header>
  <id_info>
    <org_study_id>0024520</org_study_id>
    <nct_id>NCT03039179</nct_id>
  </id_info>
  <brief_title>Polyurethane Foam on the Heel for Prevention in Children</brief_title>
  <acronym>SCHIUMABIMB</acronym>
  <official_title>Effectiveness of Polyurethane Foam in Preventing the Onset of Pressure Sores in a Pediatric Orthopedic Population: 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 aim of the study is to assess whether&#xD;
      by placing a polyurethane foam dress at the heel in the immediate postoperative period until&#xD;
      removal of the Walker, the rate of skin lesion and pain is reduced.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2014</start_date>
  <completion_date type="Actual">August 31, 2015</completion_date>
  <primary_completion_date type="Actual">July 31, 2015</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 (Numbers of Participants With 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.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (Score on the &quot;Numeric Rating Scale&quot;)</measure>
    <time_frame>up to the first 3 days post intervention</time_frame>
    <description>Pain Score on the &quot;Numeric Rating Scale&quot; &gt; 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Flat Foot</condition>
  <condition>Pressure Ulcer</condition>
  <arm_group>
    <arm_group_label>Polyurethane foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only application of the Walker in the immediate postoperative period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>polyurethane foam dress</intervention_name>
    <description>Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
    <arm_group_label>Polyurethane foam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged &gt; 3 years underwent surgery 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 after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 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>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>February 1, 2017</results_first_submitted>
  <results_first_submitted_qc>February 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2017</results_first_posted>
  <last_update_submitted>January 22, 2020</last_update_submitted>
  <last_update_submitted_qc>January 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</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>
    <mesh_term>Pressure Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study began on May 2014 and ended in May 2015 when the eighties patient was enrolled.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Polyurethane Foam</title>
          <description>polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
        </group>
        <group group_id="P2">
          <title>Standard Care</title>
          <description>Only application of the Walker in the immediate postoperative period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Polyurethane Foam</title>
          <description>polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
        </group>
        <group group_id="B2">
          <title>Standard Care</title>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.79" spread="1.27"/>
                    <measurement group_id="B2" value="11.64" spread="1.44"/>
                    <measurement group_id="B3" value="11.71" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>type of surgery:Calcaneal Osteotomy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>type of analgesia:peripheral nerve blocks analgesia</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)</title>
        <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.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.</description>
        <time_frame>every day until discharge (expected average of 3 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyurethane Foam</title>
            <description>polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
          </group>
        </group_list>
        <measure>
          <title>Heel Pressure Sores (Numbers of Participants With Heel Pressure Sores)</title>
          <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.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain (Score on the &quot;Numeric Rating Scale&quot;)</title>
        <description>Pain Score on the &quot;Numeric Rating Scale&quot; &gt; 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.</description>
        <time_frame>up to the first 3 days post intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Polyurethane Foam</title>
            <description>polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
          </group>
          <group group_id="O2">
            <title>Standard Care</title>
          </group>
        </group_list>
        <measure>
          <title>Pain (Score on the &quot;Numeric Rating Scale&quot;)</title>
          <description>Pain Score on the &quot;Numeric Rating Scale&quot; &gt; 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Polyurethane Foam</title>
          <description>polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker</description>
        </group>
        <group group_id="E2">
          <title>Standard Care</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Head of the Research Nursing Unit</name_or_title>
      <organization>Istituto Ortopedico Rizzoli</organization>
      <phone>0516366694 ext 0039</phone>
      <email>cristiana.forni@ior.it</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03039179
org study id: 0024520
nct id: NCT03039179
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 aim of the study is to assess whether
      by placing a polyurethane foam dress at the heel in the immediate postoperative period until
      removal of the Walker, the rate of skin lesion and pain is reduced.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Heel Pressure Sores (Numbers of Participants With 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.: Grade 1: Non-blanchable erythema of intact skin. Discoloration of the skin, warmth, oedema, induration or hardness may also be used as indicators, particularly in individuals with darker skin. Grade 2: Partial thickness skin loss involving epidermis, dermis, or both. The ulcer is superficial and presents clinically as an abrasion or blister. Grade 3: Full thickness skin loss involving damage to or necrosis of subcutaneous tissue that may extend down to, but not through, underlying fascia. Grade 4: Extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures with or without full thickness skin loss.
measure: Pain (Score on the "Numeric Rating Scale")
time frame: up to the first 3 days post intervention
description: Pain Score on the "Numeric Rating Scale" > 3. The scale had values from 0 to 10 where zero represented no pain and 10 the worst possible pain. More than 3 means pain.
arm group label: Polyurethane foam
arm group type: Experimental
arm group label: standard care
arm group type: No Intervention
description: Only application of the Walker in the immediate postoperative period.
intervention type: Device
intervention name: polyurethane foam dress
description: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
arm group label: Polyurethane foam
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Caterina Guerra, RN
role: Principal Investigator
affiliation: Istituto Ortopedico Rizzoli
responsible party type: Sponsor
mesh term: Flatfoot
mesh term: Pressure Ulcer
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 