<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/NCT03020420</url>
  </required_header>
  <id_info>
    <org_study_id>Cicatricell</org_study_id>
    <nct_id>NCT03020420</nct_id>
  </id_info>
  <brief_title>Clinical Trial To Study The Anti-scarring Effect Of Cicatricell</brief_title>
  <acronym>Cicatricell</acronym>
  <official_title>Clinical Trial To Study The Anti-scarring Effect Of Cicatricell</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toledo Health Science Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toledo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tries to prove that Cicatricell cream significantly reduces scarring with better&#xD;
      wound appearance as compared to no treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At 1st post operative follow up visit, surgical incision(s) will be assessed for healing,&#xD;
      after the sutures/staples/steri-strips are removed. To be included in the study the incision&#xD;
      must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included.&#xD;
      The incisions will be divided into two sections, using an imaginary line between top and&#xD;
      bottom, or left and right. One side of the imaginary line will have cicatricell cream applied&#xD;
      2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary&#xD;
      line will remain untreated. In the case of a bilateral incision, as in bilateral breast&#xD;
      mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision&#xD;
      and the 2nd incision will be untreated. The incision(s) will be its own control group. At the&#xD;
      end of the treatment phase the incision(s) will be assessed again to compare the healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2015</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved wound appearance</measure>
    <time_frame>8 weeks to 6 months</time_frame>
    <description>improved wound appearance by surface area measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>improved wound appearance</measure>
    <time_frame>8 weeks to 6 months</time_frame>
    <description>wound indentation measurement with caliper</description>
  </primary_outcome>
  <primary_outcome>
    <measure>improved wound appearance</measure>
    <time_frame>8 weeks to 6 months</time_frame>
    <description>wound bulge measured with caliper</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Vancouver Scar Scale</measure>
    <time_frame>8 weeks to 6 months</time_frame>
    <description>a scale of visual assessment of a scar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Manchester Scar Scale</measure>
    <time_frame>8 weeks to 6 months</time_frame>
    <description>A new quantitative scale for clinical scar assessment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Surgical Incisions</condition>
  <arm_group>
    <arm_group_label>treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receive cicatricell cream</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>to treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cicatricell Cream</intervention_name>
    <description>Cream to be applied 2 times a day for 8weeks to 6 months</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed IRB approved, written informed consent.&#xD;
&#xD;
          -  Patient from 18 to 60 years of age.&#xD;
&#xD;
          -  Patient who recently underwent a surgery involving linear surgical skin incisions of&#xD;
             5cm or more or patients with two exactly symmetrical separate incisions like bilateral&#xD;
             inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known skin allergies.&#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>Chris Eisenhauer</last_name>
    <phone>4193836784</phone>
    <email>christina.eisenhaue@utoledo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Munier Nazzal, MD</last_name>
    <phone>4193835150</phone>
    <email>munier.nazzal@utoledo.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UTMC</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chris Eisenhauer</last_name>
      <phone>419-383-6784</phone>
      <email>christina.eisenhauer@utoledo.edu</email>
    </contact>
    <contact_backup>
      <last_name>Munier Nazzal, MD</last_name>
      <phone>419-383-6810</phone>
      <email>munier.nazzal@utoledo.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Munier Nazzal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 16, 2015</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 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>Surgical Wound</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/NCT03020420
org study id: Cicatricell
nct id: NCT03020420
lead sponsor: 
has dmc: No
This study tries to prove that Cicatricell cream significantly reduces scarring with better
      wound appearance as compared to no treatment.
At 1st post operative follow up visit, surgical incision(s) will be assessed for healing,
      after the sutures/staples/steri-strips are removed. To be included in the study the incision
      must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included.
      The incisions will be divided into two sections, using an imaginary line between top and
      bottom, or left and right. One side of the imaginary line will have cicatricell cream applied
      2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary
      line will remain untreated. In the case of a bilateral incision, as in bilateral breast
      mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision
      and the 2nd incision will be untreated. The incision(s) will be its own control group. At the
      end of the treatment phase the incision(s) will be assessed again to compare the healing.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Improved wound appearance
time frame: 8 weeks to 6 months
description: improved wound appearance by surface area measurement
measure: improved wound appearance
time frame: 8 weeks to 6 months
description: wound indentation measurement with caliper
measure: improved wound appearance
time frame: 8 weeks to 6 months
description: wound bulge measured with caliper
measure: Modified Vancouver Scar Scale
time frame: 8 weeks to 6 months
description: a scale of visual assessment of a scar
measure: Manchester Scar Scale
time frame: 8 weeks to 6 months
description: A new quantitative scale for clinical scar assessment
arm group label: treatment arm
arm group type: Experimental
description: receive cicatricell cream
arm group label: control arm
arm group type: No Intervention
description: to treatment
intervention type: Other
intervention name: Cicatricell Cream
description: Cream to be applied 2 times a day for 8weeks to 6 months
arm group label: treatment arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Chris Eisenhauer
phone: 4193836784
email: christina.eisenhaue@utoledo.edu
last name: Munier Nazzal, MD
phone: 4193835150
email: munier.nazzal@utoledo.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Surgical Wound
sharing ipd: No