<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/NCT03026270</url>
  </required_header>
  <id_info>
    <org_study_id>13386/2011</org_study_id>
    <nct_id>NCT03026270</nct_id>
  </id_info>
  <brief_title>Effect of Therapeutical Paraffin in the Malleability of Burned Skin</brief_title>
  <official_title>Effect of Therapeutical Paraffin Wax Bath in the Malleability of Burned Skin</official_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>
      Effect of therapeutical paraffin wax bath in the malleability of burned skin&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The altered biomechanical properties of the skin entail limitation of movement, it have been&#xD;
      important the statement of resources aimed at increasing skin suppleness. The objective of&#xD;
      the study is to evaluate the effect of therapeutic paraffin in biophysical characteristics of&#xD;
      the burned skin with or without scar hypertrophic. For this, 60 volunteers will be evaluated&#xD;
      in the age group of 18-60 years, of both sexes, with deep second degree and third degree&#xD;
      burns and evaluated areas submitted to therapeutic procedures, divided evenly into scar areas&#xD;
      and normal skin. Applications will be set randomly by lot, with cross design (cross-over),&#xD;
      and a minimum interval of seven days (wash-out) of the activities. The biophysical and&#xD;
      biomechanical parameters of the skin will be assessed noninvasively by Cutometer of the model&#xD;
      (MPA) 580, device to measure elasticity of the upper skin layer using negative pressure, and&#xD;
      the durometer, measure hardness of the skin, before, immediately after 0, 10, 20 and 30&#xD;
      minutes of intervention with therapeutic paraffin in different procedures (number of layers&#xD;
      and thermal insulation). Sociodemographic, clinical and surgical data of the volunteers will&#xD;
      be evaluated by SPSS 15 (Statistical Analysis Software). The normality of the data will be&#xD;
      verified by the Shapiro-Wilk test, and the effect of therapeutic procedures over time&#xD;
      evaluated by the Friedman test (intragroup) and the test Kruskal-Wallis post hoc Dunn for&#xD;
      comparisons between different funds (intergroup), p &lt;0.05, will evaluated by software SPSS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distensibility of burned hypertrophic scar</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>Will be evaluated through the Cutometer®-MPA 580 of the intervention with therapeutic paraffin, being constituted by a small probe with diameter of 4 mm coupled in the equipment. The mechanism of action consists of deformation of the skin caused by suction, ie negative pressure giving a measured value. Once applied to the skin, an infrared light and a sensor located inside the probe perform the measurement of the distension of the skin during the period of continuous suction, followed by the phase of off where there is no suction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hardness of burned hypertrophic scar before, immediately after 0, 10, 20 and 30 minutes.</measure>
    <time_frame>up to 30 minutes</time_frame>
    <description>The instrument was used immediately after 0, 10, 20 and 30 minutes of therapeutic paraffin intervention, always in a position perpendicular to the surface of the skin to minimize errors due to the inclination of the device and repeated three times , To obtain an average of values, intervals for 10 seconds between evaluations (Klinger, et al., 2013)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Burn</condition>
  <arm_group>
    <arm_group_label>seven layers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ten layers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Paraffin</intervention_name>
    <description>The application of paraffin wax will be performed with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide), will spend several layers with the brush into two distinct groups, seven or ten layers depending on the outcome of randomisation, in the region of interest of the upper limb, being scarred, surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded</description>
    <arm_group_label>seven layers</arm_group_label>
    <arm_group_label>ten layers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Will be included in the study individuals who were victims of 2 deep burns or 3rd&#xD;
             grade being subjected to grafting autogenous procedures, with or without the presence&#xD;
             of hypertrophic scar, normal skin of individuals, ie without tissue damage and to&#xD;
             agree to sign the term free and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They will be included in this study individuals with diseases or deformities that&#xD;
             affect the structure and function of the skin.&#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_contact>
    <last_name>Elaine Guirro</last_name>
    <phone>55(16)3315-0215</phone>
    <email>ecguirro@fmrp.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thais Amaral</last_name>
    <phone>55(16)3315-0215</phone>
    <email>thais.pescarolo.amaral@usp.br</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</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 Doctor postgraduation Program in Rehabilitation and Functional Performance</investigator_title>
  </responsible_party>
  <keyword>Physiotherapy</keyword>
  <keyword>Paraffin</keyword>
  <keyword>Burn</keyword>
  <keyword>Contracture</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03026270
org study id: 13386/2011
nct id: NCT03026270
lead sponsor: 
has dmc: Yes
Effect of therapeutical paraffin wax bath in the malleability of burned skin
The altered biomechanical properties of the skin entail limitation of movement, it have been
      important the statement of resources aimed at increasing skin suppleness. The objective of
      the study is to evaluate the effect of therapeutic paraffin in biophysical characteristics of
      the burned skin with or without scar hypertrophic. For this, 60 volunteers will be evaluated
      in the age group of 18-60 years, of both sexes, with deep second degree and third degree
      burns and evaluated areas submitted to therapeutic procedures, divided evenly into scar areas
      and normal skin. Applications will be set randomly by lot, with cross design (cross-over),
      and a minimum interval of seven days (wash-out) of the activities. The biophysical and
      biomechanical parameters of the skin will be assessed noninvasively by Cutometer of the model
      (MPA) 580, device to measure elasticity of the upper skin layer using negative pressure, and
      the durometer, measure hardness of the skin, before, immediately after 0, 10, 20 and 30
      minutes of intervention with therapeutic paraffin in different procedures (number of layers
      and thermal insulation). Sociodemographic, clinical and surgical data of the volunteers will
      be evaluated by SPSS 15 (Statistical Analysis Software). The normality of the data will be
      verified by the Shapiro-Wilk test, and the effect of therapeutic procedures over time
      evaluated by the Friedman test (intragroup) and the test Kruskal-Wallis post hoc Dunn for
      comparisons between different funds (intergroup), p <0.05, will evaluated by software SPSS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Distensibility of burned hypertrophic scar
time frame: up to 30 minutes
description: Will be evaluated through the Cutometer®-MPA 580 of the intervention with therapeutic paraffin, being constituted by a small probe with diameter of 4 mm coupled in the equipment. The mechanism of action consists of deformation of the skin caused by suction, ie negative pressure giving a measured value. Once applied to the skin, an infrared light and a sensor located inside the probe perform the measurement of the distension of the skin during the period of continuous suction, followed by the phase of off where there is no suction.
measure: Hardness of burned hypertrophic scar before, immediately after 0, 10, 20 and 30 minutes.
time frame: up to 30 minutes
description: The instrument was used immediately after 0, 10, 20 and 30 minutes of therapeutic paraffin intervention, always in a position perpendicular to the surface of the skin to minimize errors due to the inclination of the device and repeated three times , To obtain an average of values, intervals for 10 seconds between evaluations (Klinger, et al., 2013)
arm group label: seven layers
arm group type: Other
description: Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)
arm group label: ten layers
arm group type: Other
description: Volunteers will be submitted to the application of seven layers therapy paraffin surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded. .The Application will be made with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide)
intervention type: Other
intervention name: Paraffin
description: The application of paraffin wax will be performed with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide), will spend several layers with the brush into two distinct groups, seven or ten layers depending on the outcome of randomisation, in the region of interest of the upper limb, being scarred, surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded
arm group label: seven layers
arm group label: ten layers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Elaine Guirro
phone: 55(16)3315-0215
email: ecguirro@fmrp.usp.br
last name: Thais Amaral
phone: 55(16)3315-0215
email: thais.pescarolo.amaral@usp.br
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Elaine Caldeira de Oliveira Guirro
investigator title: Professor Doctor postgraduation Program in Rehabilitation and Functional Performance
sharing ipd: Undecided