<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/NCT02185950</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1146-7342</org_study_id>
    <nct_id>NCT02185950</nct_id>
  </id_info>
  <brief_title>The Effects of Therapeutic Resources on Structure and Function of Normal and Burned Skin</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Burning produces changes in the biomechanical properties of the skin causing limitation of&#xD;
      movement. The increase in skin suppleness is very important in the rehabilitation process,&#xD;
      since its increase makes therapeutic interventions aimed at increasing the range of motion,&#xD;
      thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80&#xD;
      years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão&#xD;
      Preto. There will be a traditional physical therapy evaluation as well as evaluation of the&#xD;
      specific characteristics of the burn and scar. The temperature of the region will be assessed&#xD;
      by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and&#xD;
      their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10,&#xD;
      20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous&#xD;
      application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep&#xD;
      second degree burn or third degree, and the application time of 2 minutes for each effective&#xD;
      radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of&#xD;
      application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between&#xD;
      100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will&#xD;
      be set by random draw (design crusader cross-over) with an interval of 7 days between&#xD;
      applications (wash-out). The data will be submitted to analysis of normality by the&#xD;
      Shapiro-Wilk test, and the behavior of the effect between groups and pre-and&#xD;
      post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or&#xD;
      Friedman, p &lt;0.05&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">January 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Elasticity of skin and scar</measure>
    <time_frame>3 years</time_frame>
    <description>The measurement of skin and scar elasticity will be measured by the used a noninvasive assessment equipment, Cutometer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Erythema of skin and scar</measure>
    <time_frame>3 years</time_frame>
    <description>The measurement of skin and scar erythema will be measured by the probe accessory Cutometer, Mexameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fiber direction of skin and scar</measure>
    <time_frame>3 years</time_frame>
    <description>The measurement of skin and scar fiber direction will be measured by the probe accessory Cutometer, Reviscometer.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Burn</condition>
  <condition>Skin Graft</condition>
  <arm_group>
    <arm_group_label>Ultrasound group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm, and the application parameters with a matched control side of the patient, in a region with contralateral uninjured skin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group paraffin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound group + endermotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm. The application of endermotherapy will be held shortly after the therapeutic ultrasound in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group paraffin + endermotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.The application of endermotherapy will be held shortly after the paraffin therapy in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound</intervention_name>
    <arm_group_label>Ultrasound group</arm_group_label>
    <arm_group_label>Ultrasound group + endermotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>paraffin</intervention_name>
    <arm_group_label>Group paraffin</arm_group_label>
    <arm_group_label>Group paraffin + endermotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endermotherapy</intervention_name>
    <arm_group_label>Group paraffin + endermotherapy</arm_group_label>
    <arm_group_label>Ultrasound group + endermotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Victims of deep second degree burns and third degree with a length of at least 1% of&#xD;
             body surface area burned&#xD;
&#xD;
          -  Postoperative graft skin (4 and 6 months)&#xD;
&#xD;
          -  Anywhere in the body that has area to uninjured contralateral control&#xD;
&#xD;
          -  Good state of physical and mental health&#xD;
&#xD;
          -  Aged between 20 and 80 years&#xD;
&#xD;
          -  Both genders&#xD;
&#xD;
          -  Irrespective of race, class or social group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers with illnesses or deformities that may interfere with evaluation and&#xD;
             procedures&#xD;
&#xD;
          -  Volunteers which do not accept signing the Instrument of Consent and do not meet the&#xD;
             inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elaine Guirro, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elaine Guirro, PhD</last_name>
    <phone>+551536024584</phone>
    <email>ecguirro@fmrp.usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of São Paulo</name>
      <address>
        <city>RibeirãoPreto</city>
        <state>São paulo</state>
        <zip>14049-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elaine Guirro, PhD</last_name>
      <phone>+551636024584</phone>
      <email>ecguirro@fmrp.usp.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.fmrp.usp.br</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 15, 2013</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Elaine Caldeira de Oliveira Guirro</investigator_full_name>
    <investigator_title>Professor, PT, PhD</investigator_title>
  </responsible_party>
  <keyword>Burn</keyword>
  <keyword>Skin graft</keyword>
  <keyword>Elasticity</keyword>
  <keyword>Skin</keyword>
  <keyword>Physical therapy modalities</keyword>
  <!-- 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/NCT02185950
org study id: U1111-1146-7342
nct id: NCT02185950
lead sponsor: 
has dmc: Yes
Burning produces changes in the biomechanical properties of the skin causing limitation of
      movement. The increase in skin suppleness is very important in the rehabilitation process,
      since its increase makes therapeutic interventions aimed at increasing the range of motion,
      thus improving functional pattern. Will be evaluated 60 volunteers of both sexes aged 20-80
      years seen at the Burns Unit of the Clinical Hospital of the Faculty of Medicine of Ribeirão
      Preto. There will be a traditional physical therapy evaluation as well as evaluation of the
      specific characteristics of the burn and scar. The temperature of the region will be assessed
      by thermography, and biophysical parameters and biomechanical skin evaluated by Cutometer and
      their accessory probes (mexameter, reviscometer, sebometer) before, immediately after and 10,
      20 and 30 minutes of application of therapeutic resources. Volunteers will undergo continuous
      application of ultrasound with 3 MHz and intensity of 1 W/cm2 in the region due to scar deep
      second degree burn or third degree, and the application time of 2 minutes for each effective
      radiation area of the head (ERA) in a predetermined region of 9X5 cm a total of 4 minutes of
      application, therapy paraffin 20 minutes and 4 minutes endermology negative pressure between
      100 and 200mmHg, in a continuous mode with glass head (1.5cm in diameter .) Applications will
      be set by random draw (design crusader cross-over) with an interval of 7 days between
      applications (wash-out). The data will be submitted to analysis of normality by the
      Shapiro-Wilk test, and the behavior of the effect between groups and pre-and
      post-intervention will be evaluated by two-way ANOVA followed by post-hoc (Bonferroni) or
      Friedman, p <0.05
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Elasticity of skin and scar
time frame: 3 years
description: The measurement of skin and scar elasticity will be measured by the used a noninvasive assessment equipment, Cutometer.
measure: Erythema of skin and scar
time frame: 3 years
description: The measurement of skin and scar erythema will be measured by the probe accessory Cutometer, Mexameter.
measure: Fiber direction of skin and scar
time frame: 3 years
description: The measurement of skin and scar fiber direction will be measured by the probe accessory Cutometer, Reviscometer.
arm group label: Ultrasound group
arm group type: Experimental
description: Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm, and the application parameters with a matched control side of the patient, in a region with contralateral uninjured skin.
arm group label: Group paraffin
arm group type: Experimental
description: Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.
arm group label: Ultrasound group + endermotherapy
arm group type: Experimental
description: Therapeutic ultrasound, 3 MHz, continuous with intensity 1W/cm2 will be applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) with exposure time of 2 minutes for each effective radiation area head (ERA), a total of 4 minutes of application in an area of 9X5 cm. The application of endermotherapy will be held shortly after the therapeutic ultrasound in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.
arm group label: Group paraffin + endermotherapy
arm group type: Experimental
description: Paraffin therapy is heated with thermostat own equipment, being applied to the selected region (burn scar deep 2nd degree or 3rd degree, grafted) and control (uninjured), with a length of 9X5 cm, at a temperature of 38 ° C with appropriate brush in layers (4 layers), remaining for 20 minutes. After the period of application of paraffin will be removed and discarded, with no reuse.The application of endermotherapy will be held shortly after the paraffin therapy in a timely manner across the surface of the scar, for about 2 seconds per head area with a negative pressure between 100-200 mmHg, a total of 4 minutes application in an area of 9 x 5 cm. The same application parameters will be performed with one hand matched control patient, in a region with contralateral uninjured skin.
intervention type: Device
intervention name: ultrasound
arm group label: Ultrasound group
arm group label: Ultrasound group + endermotherapy
intervention type: Device
intervention name: paraffin
arm group label: Group paraffin
arm group label: Group paraffin + endermotherapy
intervention type: Device
intervention name: endermotherapy
arm group label: Group paraffin + endermotherapy
arm group label: Ultrasound group + endermotherapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Elaine Guirro, PhD
role: Principal Investigator
affiliation: University of São Paulo
last name: Elaine Guirro, PhD
phone: +551536024584
email: ecguirro@fmrp.usp.br
facility: 
status: Recruiting
contact: 
country: Brazil
url: http://www.fmrp.usp.br
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Elaine Caldeira de Oliveira Guirro
investigator title: Professor, PT, PhD