<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/NCT03302988</url>
  </required_header>
  <id_info>
    <org_study_id>803389</org_study_id>
    <nct_id>NCT03302988</nct_id>
  </id_info>
  <brief_title>Wound Eversion Versus Planar Closure for Face or Neck Wounds</brief_title>
  <official_title>Wound Eversion Versus Planar Closure for Wounds on the Face or Neck: a Randomized Split Wound Comparative Effectiveness Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</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>
      The aim of this study is to determine whether wound edge eversion, achieved by careful&#xD;
      placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the&#xD;
      head or neck.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been established that as wounds heal, the resultant tissue remodeling results in wound&#xD;
      contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal&#xD;
      sutures, there is less depression of the resultant scar. A prior study conducted by us at&#xD;
      this center found that wound eversion was not associated with better cosmetic outcome (1).&#xD;
      However, it was noted that most of the procedures were performed off the head and neck,&#xD;
      places where the effects of eversion were thought to be most beneficial (2) Thus our goal is&#xD;
      to now study the effects of eversion exclusively on the face and neck.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2015</start_date>
  <completion_date type="Actual">July 25, 2017</completion_date>
  <primary_completion_date type="Actual">July 6, 2016</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>Within 3 months</time_frame>
    <description>The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of sunken scars</measure>
    <time_frame>Within 3 months</time_frame>
    <description>The incidence of sunken scars or elevated scaring on each treatment side will also be determined</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Operative Wound</condition>
  <arm_group>
    <arm_group_label>Everted closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wound eversion will be achieved through buried vertical mattress suture or cuticular suture based on surgeon's preference, either buried vertical mattress suture or cuticular sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Planar closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Everted closure</intervention_name>
    <description>Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion</description>
    <arm_group_label>Everted closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Planar closure</intervention_name>
    <description>The planar side will be closed with traditional buried simple closure and running cuticular sutures</description>
    <arm_group_label>Planar closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Able to give informed consent themselves&#xD;
&#xD;
          -  Patient scheduled for cutaneous surgical procedure with predicted linear closure on&#xD;
             the face or neck&#xD;
&#xD;
          -  Willing to return for follow up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally handicapped&#xD;
&#xD;
          -  Unable to understand written and oral English&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Adults unable to consent&#xD;
&#xD;
          -  Individuals who are not yet adults (infants, children, teenagers)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Eisen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Davis, Department of Dermatology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.</citation>
    <PMID>25619206</PMID>
  </reference>
  <reference>
    <citation>Trufant JW, Leach BC. Commentary: Wound edge eversion: surgical dogma or diversion? J Am Acad Dermatol. 2015 Apr;72(4):681-2. doi: 10.1016/j.jaad.2014.09.046. No abstract available.</citation>
    <PMID>25773410</PMID>
  </reference>
  <reference>
    <citation>van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.</citation>
    <PMID>16079683</PMID>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 20, 2018</last_update_submitted>
  <last_update_submitted_qc>September 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound Edge Eversion</keyword>
  <keyword>Dermal Sutures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <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/NCT03302988
org study id: 803389
nct id: NCT03302988
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine whether wound edge eversion, achieved by careful
      placement of dermal sutures, improves the cosmetic outcome of operative wounds closed on the
      head or neck.
It has been established that as wounds heal, the resultant tissue remodeling results in wound
      contracture. Surgeons are taught that by everting wounds' edges with well-placed dermal
      sutures, there is less depression of the resultant scar. A prior study conducted by us at
      this center found that wound eversion was not associated with better cosmetic outcome (1).
      However, it was noted that most of the procedures were performed off the head and neck,
      places where the effects of eversion were thought to be most beneficial (2) Thus our goal is
      to now study the effects of eversion exclusively on the face and neck.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Each wound will have 2 treatments. The type of treatment (Type of suturing) will be chosen by random assignment
primary purpose: Other
masking: None (Open Label)
measure: Patient Observer Scar Assessment Scale (POSAS)
time frame: Within 3 months
description: The primary endpoint will be the score of two blinded reviewers using the physician observer assessment score at a three-month assessment visit.
measure: Incidence of sunken scars
time frame: Within 3 months
description: The incidence of sunken scars or elevated scaring on each treatment side will also be determined
arm group label: Everted closure
arm group type: Experimental
description: Wound eversion will be achieved through buried vertical mattress suture or cuticular suture based on surgeon's preference, either buried vertical mattress suture or cuticular sutures
arm group label: Planar closure
arm group type: Active Comparator
description: The planar side of the same wond will be closed with traditional buried simple closure and running cuticular sutures
intervention type: Other
intervention name: Everted closure
description: Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
arm group label: Everted closure
intervention type: Other
intervention name: Planar closure
description: The planar side will be closed with traditional buried simple closure and running cuticular sutures
arm group label: Planar closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Eisen, MD
role: Principal Investigator
affiliation: University of California, Davis
facility: 
country: United States
citation: Kappel S, Kleinerman R, King TH, Sivamani R, Taylor S, Nguyen U, Eisen DB. Does wound eversion improve cosmetic outcome?: Results of a randomized, split-scar, comparative trial. J Am Acad Dermatol. 2015 Apr;72(4):668-73. doi: 10.1016/j.jaad.2014.11.032. Epub 2015 Jan 23.
PMID: 25619206
citation: Trufant JW, Leach BC. Commentary: Wound edge eversion: surgical dogma or diversion? J Am Acad Dermatol. 2015 Apr;72(4):681-2. doi: 10.1016/j.jaad.2014.09.046. No abstract available.
PMID: 25773410
citation: van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.
PMID: 16079683
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No