<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/NCT03777891</url>
  </required_header>
  <id_info>
    <org_study_id>P.T.REC/012/001870</org_study_id>
    <nct_id>NCT03777891</nct_id>
  </id_info>
  <brief_title>Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars</brief_title>
  <official_title>Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars: A Single Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Hypertrophic scars and keloids are physically and mentally disturbed, and in addition, can&#xD;
      cause pain and itching. Various treatment is utilized to diminish or counteract scarring. The&#xD;
      purpose of this study was conducted to compare the effect of Silicone gel, Contractubex gel&#xD;
      and Corticosteroid Phonophoresis for Post-burn Hypertrophic Scars. Forty-five patients with&#xD;
      hypertrophic scars after 2 to 4 months post thermal burn, their age groups ranged from 20-45&#xD;
      years. Patients were randomly assigned to three groups; Group A: 15 patients (8 males and 7&#xD;
      females) received phonophoresis with Silicone gel, Group B: 15 patients (8 males and 7&#xD;
      females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6&#xD;
      females) received Corticosteroid phonophoresis. All treatment interventions were applied at a&#xD;
      frequency of 3sessions /week for 24 weeks. Outcome measures were performed through modified&#xD;
      Vancouver scar scale. The assessment was done pretreatment, after 12 weeks and after 24 weeks&#xD;
      of the treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants A convenient sample of forty-five patients, 25 male and 20 female, were&#xD;
      recruited from the Outpatient Clinic Kasr El-Ani hospital to be treated in the Outpatient&#xD;
      Clinic, Faculty of Physical Therapy, Cairo University. They were enrolled and assessed for&#xD;
      their eligibility to participate in the study. To be included in the study, patients had&#xD;
      hypertrophic scars after 2 to 4 months post thermal burn (direct flame or scald) all patients&#xD;
      injury was deep second-degree burn and their age ranged from 20-45 years, they had been free&#xD;
      from any other illness that may affect or impact the results as; skin disease, diabetes,&#xD;
      mental disorders, peripheral vascular diseases, acute viral diseases, open wound, electrical&#xD;
      and chemical burns were excluded.&#xD;
&#xD;
      Randomization Informed consent was obtained from each participant after explaining the&#xD;
      nature, purpose, and benefits of the study, informing them of their right to refuse or&#xD;
      withdraw at any time, and about the confidentiality of any obtained information. Anonymity&#xD;
      was assured through coding of all data. Participants with hypertrophic scar post burn were&#xD;
      randomly assigned into three groups (group A, group B and group C) by a blinded and an&#xD;
      independent research assistant who opened sealed envelopes that contained a&#xD;
      computer-generated randomization card. No subjects dropped out of the study after&#xD;
      randomization.&#xD;
&#xD;
      Interventions Participants were randomly assigned into group A (GA) received Silicone gel&#xD;
      phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was&#xD;
      implemented by the therapist. The ultrasound parameters were set as following, frequency: 1&#xD;
      MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is&#xD;
      Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound&#xD;
      device manufactured by Enraf Holland.&#xD;
&#xD;
      Group B (GB) received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt,&#xD;
      Germany was applied to the scar then the ultrasound was implemented by the therapist. The&#xD;
      ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the&#xD;
      treatment time was 5 minutes.&#xD;
&#xD;
      Group C (GC) received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was&#xD;
      put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe&#xD;
      over the whole scar then the ultrasound was implemented by the therapist. The ultrasound&#xD;
      parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment&#xD;
      time was 5 minutes. All groups received 72 sessions of treatment, three times per week for 24&#xD;
      weeks.&#xD;
&#xD;
      Outcome measures Scar assessment was done using the modified Vancouver scar scale (Danielsen&#xD;
      et al., 2013). The modified scale is a numerical assessment of four skin characteristics,&#xD;
      where 0 represents the person's normal skin. The characteristics include height (range 0-3),&#xD;
      pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment&#xD;
      was done before treatment, after three months (12 weeks) (post 1) and after six months (24&#xD;
      weeks) of the treatment (post 2). The final outcome was measured after six months of&#xD;
      follow-up, in terms of complete and incomplete recovery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">January 3, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of modified Vancouver scar scale</measure>
    <time_frame>pretreatment, after 12 weeks and after 24 weeks of the treatment</time_frame>
    <description>Scar assessment was done using the modified Vancouver scar scale (Danielsen et al., 2013). The modified scale is a numerical assessment of four skin characteristics, where 0 represents the person's normal skin. The characteristics include height (range 0-3), pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment was done before treatment, after three months (12 weeks) (post 1) and after six months (24 weeks) of the treatment (post 2). The final outcome was measured after six months of follow-up, in terms of complete and incomplete recovery.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Hypertrophic Scar</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received Silicone gel phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound device manufactured by Enraf Holland.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt, Germany was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>phonophoresis with different material</intervention_name>
    <description>phonophoresis with Silicone gel for group A, , Group B: 15 patients (8 males and 7 females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6 females) received Corticosteroid phonophoresis.</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients had hypertrophic scars after 2 to 4 months post thermal burn (direct flame or&#xD;
             scald) all patients injury was deep second-degree burn and their age ranged from 20-45&#xD;
             years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  skin disease, diabetes, mental disorders, peripheral vascular diseases, acute viral&#xD;
             diseases, open wound, electrical and chemical burns were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hamada A Hamada</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamada Ahmed Hamada</name>
      <address>
        <city>Cairo</city>
        <state>Giza</state>
        <zip>12625</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>HAhmed</investigator_full_name>
    <investigator_title>Deputy Director of Quality Assurance Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertrophy</mesh_term>
    <mesh_term>Cicatrix, Hypertrophic</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/NCT03777891
org study id: P.T.REC/012/001870
nct id: NCT03777891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertrophic scars and keloids are physically and mentally disturbed, and in addition, can
      cause pain and itching. Various treatment is utilized to diminish or counteract scarring. The
      purpose of this study was conducted to compare the effect of Silicone gel, Contractubex gel
      and Corticosteroid Phonophoresis for Post-burn Hypertrophic Scars. Forty-five patients with
      hypertrophic scars after 2 to 4 months post thermal burn, their age groups ranged from 20-45
      years. Patients were randomly assigned to three groups; Group A: 15 patients (8 males and 7
      females) received phonophoresis with Silicone gel, Group B: 15 patients (8 males and 7
      females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6
      females) received Corticosteroid phonophoresis. All treatment interventions were applied at a
      frequency of 3sessions /week for 24 weeks. Outcome measures were performed through modified
      Vancouver scar scale. The assessment was done pretreatment, after 12 weeks and after 24 weeks
      of the treatment.
Participants A convenient sample of forty-five patients, 25 male and 20 female, were
      recruited from the Outpatient Clinic Kasr El-Ani hospital to be treated in the Outpatient
      Clinic, Faculty of Physical Therapy, Cairo University. They were enrolled and assessed for
      their eligibility to participate in the study. To be included in the study, patients had
      hypertrophic scars after 2 to 4 months post thermal burn (direct flame or scald) all patients
      injury was deep second-degree burn and their age ranged from 20-45 years, they had been free
      from any other illness that may affect or impact the results as; skin disease, diabetes,
      mental disorders, peripheral vascular diseases, acute viral diseases, open wound, electrical
      and chemical burns were excluded.

      Randomization Informed consent was obtained from each participant after explaining the
      nature, purpose, and benefits of the study, informing them of their right to refuse or
      withdraw at any time, and about the confidentiality of any obtained information. Anonymity
      was assured through coding of all data. Participants with hypertrophic scar post burn were
      randomly assigned into three groups (group A, group B and group C) by a blinded and an
      independent research assistant who opened sealed envelopes that contained a
      computer-generated randomization card. No subjects dropped out of the study after
      randomization.

      Interventions Participants were randomly assigned into group A (GA) received Silicone gel
      phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was
      implemented by the therapist. The ultrasound parameters were set as following, frequency: 1
      MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is
      Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound
      device manufactured by Enraf Holland.

      Group B (GB) received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt,
      Germany was applied to the scar then the ultrasound was implemented by the therapist. The
      ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the
      treatment time was 5 minutes.

      Group C (GC) received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was
      put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe
      over the whole scar then the ultrasound was implemented by the therapist. The ultrasound
      parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment
      time was 5 minutes. All groups received 72 sessions of treatment, three times per week for 24
      weeks.

      Outcome measures Scar assessment was done using the modified Vancouver scar scale (Danielsen
      et al., 2013). The modified scale is a numerical assessment of four skin characteristics,
      where 0 represents the person's normal skin. The characteristics include height (range 0-3),
      pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment
      was done before treatment, after three months (12 weeks) (post 1) and after six months (24
      weeks) of the treatment (post 2). The final outcome was measured after six months of
      follow-up, in terms of complete and incomplete recovery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: change of modified Vancouver scar scale
time frame: pretreatment, after 12 weeks and after 24 weeks of the treatment
description: Scar assessment was done using the modified Vancouver scar scale (Danielsen et al., 2013). The modified scale is a numerical assessment of four skin characteristics, where 0 represents the person's normal skin. The characteristics include height (range 0-3), pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment was done before treatment, after three months (12 weeks) (post 1) and after six months (24 weeks) of the treatment (post 2). The final outcome was measured after six months of follow-up, in terms of complete and incomplete recovery.
arm group label: group A
arm group type: Experimental
description: received Silicone gel phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound device manufactured by Enraf Holland.
arm group label: group B
arm group type: Experimental
description: received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt, Germany was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes.
arm group label: group C
arm group type: Experimental
description: received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes
intervention type: Combination Product
intervention name: phonophoresis with different material
description: phonophoresis with Silicone gel for group A, , Group B: 15 patients (8 males and 7 females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6 females) received Corticosteroid phonophoresis.
arm group label: group A
arm group label: group B
arm group label: group C
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Hamada A Hamada
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: HAhmed
investigator title: Deputy Director of Quality Assurance Unit
mesh term: Hypertrophy
mesh term: Cicatrix, Hypertrophic
sharing ipd: No