<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/NCT04413383</url>
  </required_header>
  <id_info>
    <org_study_id>2023744</org_study_id>
    <nct_id>NCT04413383</nct_id>
  </id_info>
  <brief_title>Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors for Skin Surgery</brief_title>
  <acronym>TISMIS</acronym>
  <official_title>Do Patients Undergoing Dermatologic Surgery Prefer the Use of Traditional Curved Iris Scissors or the Wuennenberg Modified Curved Iris Scissors?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Every year thousands of dermatologic surgery procedures are performed at the University of&#xD;
      Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and&#xD;
      biopsies. Surgery is known to cause anxiety for patients and with these procedures performed&#xD;
      under local anesthetic on awake patients', the sights, sounds, and smells experienced during&#xD;
      the procedure can lead to an increase in their anxiety or affect their overall perception of&#xD;
      the experience. From performing and assisting with dermatologic surgery the noise associated&#xD;
      with the use of the traditional curved Iris scissors provokes an increase in patient&#xD;
      awareness to the procedure resulting in increased anxiety, triggering of the vasovagal&#xD;
      response, and expressions of annoyance by the patient. However, the modified curved Iris&#xD;
      scissors make almost no noise. The Investigators hypothesize that if patients were given the&#xD;
      comparative experience of both types of curved Iris scissors during dermatologic surgery,&#xD;
      then they will choose the modified curved Iris scissors because the lack of noise will be&#xD;
      perceived as more pleasant experience. Our objective is to perform a prospective, single&#xD;
      blinded, randomized controlled trial to determine how the noise of traditional curved Iris&#xD;
      scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during&#xD;
      dermatologic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2020</start_date>
  <completion_date type="Actual">July 14, 2021</completion_date>
  <primary_completion_date type="Actual">July 14, 2021</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Extent that patient notices curved Iris scissors</measure>
    <time_frame>3 to 8 hours (length of the patients Mohs Surgery)</time_frame>
    <description>Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extent that patient is bothered by the curved Iris scissors</measure>
    <time_frame>3 to 8 hours (length of the patients Mohs Surgery)</time_frame>
    <description>Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients Preference of curved Iris scissor</measure>
    <time_frame>3 to 8 hours (length of the patients Mohs Surgery)</time_frame>
    <description>Patient is asked during the procedure if they prefer &quot;1,&quot; surgeon uses the traditional curved Iris scissors, or &quot;2&quot; and the surgeon uses the Wuennenberg modified curved Iris scissors. The patient indicates their preference by responding &quot;1 or 2.&quot; After the procedure the patient completes a questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices and is bothered by the curved iris scissors.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Traditional Curved Iris Scissors</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The traditional curved Iris scissors are used to during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified Curved Iris Scissors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Wuennenberg modified curved Iris scissors are used during the dermatologic surgery.&#xD;
Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparative Experience</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Both the traditional and modified curved Iris scissors are used and patients are asked which they prefer. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional Curved Iris Scissors</intervention_name>
    <description>Aesculap Curved Iris Scissors</description>
    <arm_group_label>Traditional Curved Iris Scissors</arm_group_label>
    <other_name>Curved Iris Scissors</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wuennenberg Modified Curved Iris Scissors</intervention_name>
    <description>Modified Silent Curved Iris Scissors</description>
    <arm_group_label>Modified Curved Iris Scissors</arm_group_label>
    <other_name>Modified Curved Iris Scissors</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors</intervention_name>
    <description>Patients experience both types of scissors</description>
    <arm_group_label>Comparative Experience</arm_group_label>
    <other_name>Comparative Experience</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (18 years or older)&#xD;
&#xD;
          -  non-pregnant&#xD;
&#xD;
          -  patients being treated with Mohs micrographic surgery or excision on the head and neck&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not meeting above inclusion criteria will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Wuennenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia Dermatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMB</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 13, 2021</last_update_submitted>
  <last_update_submitted_qc>August 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>John Wuennenberg</investigator_full_name>
    <investigator_title>Resident Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</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/NCT04413383
org study id: 2023744
nct id: NCT04413383
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Every year thousands of dermatologic surgery procedures are performed at the University of
      Missouri Department of Dermatology, including Mohs Micrographic Surgery (MMS), Excisions, and
      biopsies. Surgery is known to cause anxiety for patients and with these procedures performed
      under local anesthetic on awake patients', the sights, sounds, and smells experienced during
      the procedure can lead to an increase in their anxiety or affect their overall perception of
      the experience. From performing and assisting with dermatologic surgery the noise associated
      with the use of the traditional curved Iris scissors provokes an increase in patient
      awareness to the procedure resulting in increased anxiety, triggering of the vasovagal
      response, and expressions of annoyance by the patient. However, the modified curved Iris
      scissors make almost no noise. The Investigators hypothesize that if patients were given the
      comparative experience of both types of curved Iris scissors during dermatologic surgery,
      then they will choose the modified curved Iris scissors because the lack of noise will be
      perceived as more pleasant experience. Our objective is to perform a prospective, single
      blinded, randomized controlled trial to determine how the noise of traditional curved Iris
      scissors vs the silent Wuennenberg modified curved Iris scissors affects patients during
      dermatologic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Extent that patient notices curved Iris scissors
time frame: 3 to 8 hours (length of the patients Mohs Surgery)
description: Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices the use of the curved iris scissors.
measure: Extent that patient is bothered by the curved Iris scissors
time frame: 3 to 8 hours (length of the patients Mohs Surgery)
description: Questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient is bothered by the curved iris scissors.
measure: Patients Preference of curved Iris scissor
time frame: 3 to 8 hours (length of the patients Mohs Surgery)
description: Patient is asked during the procedure if they prefer "1," surgeon uses the traditional curved Iris scissors, or "2" and the surgeon uses the Wuennenberg modified curved Iris scissors. The patient indicates their preference by responding "1 or 2." After the procedure the patient completes a questionnaire with an ordinal scale from 1 to 10 to assess the extent that patient notices and is bothered by the curved iris scissors.
arm group label: Traditional Curved Iris Scissors
arm group type: Active Comparator
description: The traditional curved Iris scissors are used to during the dermatologic surgery. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.
arm group label: Modified Curved Iris Scissors
arm group type: Experimental
description: The Wuennenberg modified curved Iris scissors are used during the dermatologic surgery.
Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.
arm group label: Comparative Experience
arm group type: Other
description: Both the traditional and modified curved Iris scissors are used and patients are asked which they prefer. Patients complete a survey after the surgery on sights, sounds and smells experienced during the procedure.
intervention type: Other
intervention name: Traditional Curved Iris Scissors
description: Aesculap Curved Iris Scissors
arm group label: Traditional Curved Iris Scissors
other name: Curved Iris Scissors
intervention type: Other
intervention name: Wuennenberg Modified Curved Iris Scissors
description: Modified Silent Curved Iris Scissors
arm group label: Modified Curved Iris Scissors
other name: Modified Curved Iris Scissors
intervention type: Other
intervention name: Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors
description: Patients experience both types of scissors
arm group label: Comparative Experience
other name: Comparative Experience
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: John P Wuennenberg, MD
role: Principal Investigator
affiliation: University of Missouri-Columbia Dermatology
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: John Wuennenberg
investigator title: Resident Physician
mesh term: Skin Neoplasms
sharing ipd: No