xml: <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/NCT05981443</url>
    </required_header>
    <id_info>
      <org_study_id>BrowPtosis</org_study_id>
      <nct_id>NCT05981443</nct_id>
    </id_info>
    <brief_title>An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures</brief_title>
    <official_title>Scar Analysis in Direct Excision Brow Lift: Comparing Octyl-2- Cyanoacrylate (Dermabond) Versus Non-absorbable Sutures</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cody Blanchard</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Kentucky</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin&#xD;
        closure after brow ptosis surgery. The main questions it aims to answer are:&#xD;
  &#xD;
          -  if Dermabond provides equivalent wound healing compared to conventional non-absorbable&#xD;
             skin suture techniques&#xD;
  &#xD;
          -  if Dermabond provides equivalent scar appearance compared to conventional non-absorbable&#xD;
             suture techniques&#xD;
  &#xD;
          -  if Dermabond results in equivalent complication rates compared to conventional&#xD;
             non-absorbable suture techniques Participants will have be randomly selected to have&#xD;
             either Dermabond or non-absorbable suture closure methods. Scar analysis and both&#xD;
             participant and provider surveys will be performed to assess the differences between&#xD;
             groups, if any.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Scar Appearance</measure>
      <time_frame>10 days</time_frame>
      <description>Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Scar Appearance</measure>
      <time_frame>6 weeks</time_frame>
      <description>Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complication Rates</measure>
      <time_frame>6 weeks</time_frame>
      <description>Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Brow Ptosis</condition>
    <condition>Surgical Wound</condition>
    <arm_group>
      <arm_group_label>Active Comparator: Dermabond</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The surgical wound over one eyebrow will be closed with Dermabond.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Comparator: Non-Absorbable Sutures</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The surgical wound over one eyebrow will be closed with non-absorbable sutures.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Dermabond</intervention_name>
      <description>Use of Dermabond to close surgical incisions instead of non-absorbable sutures</description>
      <arm_group_label>Active Comparator: Dermabond</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non-Absorbable Sutures</intervention_name>
      <description>Use of conventional non-absorbable sutures to close surgical incisions</description>
      <arm_group_label>Active Comparator: Non-Absorbable Sutures</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing bilateral direct excision brow lift for brow ptosis at the&#xD;
               University of Kentucky Medical Center.&#xD;
  &#xD;
            -  Patients &gt; 18 years of age.&#xD;
  &#xD;
            -  Patients must be able to follow up at the specified intervals.&#xD;
  &#xD;
            -  Patients who are able to give their own informed consent.&#xD;
  &#xD;
            -  Health Status: Variable health status reflective of general population of Kentucky.&#xD;
               Patients will be healthy enough to be seen in an office setting.&#xD;
  &#xD;
            -  All patients will need to be proficient in the English language to understand the&#xD;
               scale used for scar assessment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients &lt;18 years of age or &gt;100&#xD;
  &#xD;
            -  Allergy to Dermabond&#xD;
  &#xD;
            -  Adults with impaired consent capacity&#xD;
  &#xD;
            -  Incarcerated individuals&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Peter Timoney, MD</last_name>
      <role>Study Director</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cody Blanchard, MD</last_name>
      <phone>859-323-5875</phone>
      <email>cody.blanchard@uky.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peter Timoney, MD</last_name>
      <phone>859-323-5875</phone>
      <email>pjtimo2@uky.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Kentucky</name>
        <address>
          <city>Lexington</city>
          <state>Kentucky</state>
          <zip>40508</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Peter Timoney, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Cody Blanchard</investigator_full_name>
      <investigator_title>Resident Physician, Ophthalmology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prolapse</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981443
  org study id: BrowPtosis
  nct id: NCT05981443
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The goal of this clinical trial is to compare Dermabond with non-absorbable sutures in skin
        closure after brow ptosis surgery. The main questions it aims to answer are:
  
          -  if Dermabond provides equivalent wound healing compared to conventional non-absorbable
             skin suture techniques
  
          -  if Dermabond provides equivalent scar appearance compared to conventional non-absorbable
             suture techniques
  
          -  if Dermabond results in equivalent complication rates compared to conventional
             non-absorbable suture techniques Participants will have be randomly selected to have
             either Dermabond or non-absorbable suture closure methods. Scar analysis and both
             participant and provider surveys will be performed to assess the differences between
             groups, if any.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Scar Appearance
  time frame: 10 days
  description: Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.
  measure: Scar Appearance
  time frame: 6 weeks
  description: Patient and Observer Scar Assessment Scale filled out by both patient and provider at both postoperative visits of both Dermabond and non-absorbable sutures. This survey is scaled from 0-10, with 0 being normal skin and 10 being very different skin. Lower scores are desired on this survey.
  measure: Complication Rates
  time frame: 6 weeks
  description: Complication rates of both Dermabond and non-absorbable sutures to include dehiscence and infection
  arm group label: Active Comparator: Dermabond
  arm group type: Experimental
  description: The surgical wound over one eyebrow will be closed with Dermabond.
  arm group label: Active Comparator: Non-Absorbable Sutures
  arm group type: Active Comparator
  description: The surgical wound over one eyebrow will be closed with non-absorbable sutures.
  intervention type: Device
  intervention name: Dermabond
  description: Use of Dermabond to close surgical incisions instead of non-absorbable sutures
  arm group label: Active Comparator: Dermabond
  intervention type: Other
  intervention name: Non-Absorbable Sutures
  description: Use of conventional non-absorbable sutures to close surgical incisions
  arm group label: Active Comparator: Non-Absorbable Sutures
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Peter Timoney, MD
  role: Study Director
  affiliation: University of Kentucky
  last name: Cody Blanchard, MD
  phone: 859-323-5875
  email: cody.blanchard@uky.edu
  last name: Peter Timoney, MD
  phone: 859-323-5875
  email: pjtimo2@uky.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Cody Blanchard
  investigator title: Resident Physician, Ophthalmology
  mesh term: Prolapse
  mesh term: Surgical Wound