<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/NCT04506580</url>
  </required_header>
  <id_info>
    <org_study_id>Dermabond vs. Subcuticular</org_study_id>
    <nct_id>NCT04506580</nct_id>
  </id_info>
  <brief_title>Comparison of Postoperative Wound Between Dermabond Prineo(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty</brief_title>
  <official_title>Comparison of Postoperative Wound Between Dermabond PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and Subcuticular Suture in Simultaneous Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</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>
      This study aims to compare the clinical results of postoperative wound between Dermabond&#xD;
      PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in&#xD;
      simultaneous total knee arthroplasty&#xD;
&#xD;
      There is previous studies over whether or not to use skin adhesive material is superior or&#xD;
      inferior to subcuticular suture This study prospectively randomized patients receiving&#xD;
      bilateral total knee arthroplasty(TKA). Patients preference and clinical results was&#xD;
      investigated in both knee of same patients who received skin adhesive or subcuticular suture&#xD;
      in each knee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>wound Hypertrophy scale at postoperative 6 month</measure>
    <time_frame>at postoperative 6 months</time_frame>
    <description>Vancouver scar scale, patient and observer report scar assessment scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin closure time</measure>
    <time_frame>operation day</time_frame>
    <description>Skin closure time for each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound complication</measure>
    <time_frame>postoperative 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound complication</measure>
    <time_frame>postoperative 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound complication</measure>
    <time_frame>postoperative 3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>wound complication</measure>
    <time_frame>postoperative 6 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stitch out time</measure>
    <time_frame>postoperative 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stitch out visual visual analogue scale(VAS)</measure>
    <time_frame>postoperative 2 weeks</time_frame>
    <description>VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Osteoarthritis, Knee Cutaneous Suture, Dermabond, Subcuticular Suture</condition>
  <arm_group>
    <arm_group_label>Dermabond group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using DERMABOND™ PRINEO™</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcuticular group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using 3-0 Dermalon with subcuticular suture method</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture</intervention_name>
    <description>DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee</description>
    <arm_group_label>Dermabond group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients for total knee arthroplasty&#xD;
&#xD;
          -  having medicare insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatoid arthritis&#xD;
&#xD;
          -  Other inflammatory arthritis&#xD;
&#xD;
          -  Neuropsychiatric patients&#xD;
&#xD;
          -  Allergy or intolerance to study material&#xD;
&#xD;
          -  Patients with an American Society of Anesthesiologists(ASA) score of IV (angina,&#xD;
             congestive heart failure, dementia, cerebrovascular accident)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yong In, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>the Catholic Univerisity of Korea Seoul St Mary's hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>February 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Yong In</investigator_full_name>
    <investigator_title>Head of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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/NCT04506580
org study id: Dermabond vs. Subcuticular
nct id: NCT04506580
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to compare the clinical results of postoperative wound between Dermabond
      PRINEO™(2-octyl Cyanoacrylate adhesive and polyester mesh) and subcuticular suture in
      simultaneous total knee arthroplasty

      There is previous studies over whether or not to use skin adhesive material is superior or
      inferior to subcuticular suture This study prospectively randomized patients receiving
      bilateral total knee arthroplasty(TKA). Patients preference and clinical results was
      investigated in both knee of same patients who received skin adhesive or subcuticular suture
      in each knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double blind
measure: wound Hypertrophy scale at postoperative 6 month
time frame: at postoperative 6 months
description: Vancouver scar scale, patient and observer report scar assessment scale
measure: Skin closure time
time frame: operation day
description: Skin closure time for each group
measure: wound complication
time frame: postoperative 2 weeks
measure: wound complication
time frame: postoperative 6 weeks
measure: wound complication
time frame: postoperative 3 month
measure: wound complication
time frame: postoperative 6 month
measure: Stitch out time
time frame: postoperative 2 weeks
measure: Stitch out visual visual analogue scale(VAS)
time frame: postoperative 2 weeks
description: VAS range from 1 to 10 ( 1means minimal pain 10 means maximal pain)
arm group label: Dermabond group
arm group type: Experimental
description: close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using DERMABOND™ PRINEO™
arm group label: Subcuticular group
arm group type: No Intervention
description: close capsule using 1-0 vicryl suture material close subq layer using 1-0 and 2-0 bicryl suture material and close skin layer using 3-0 Dermalon with subcuticular suture method
intervention type: Procedure
intervention name: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture
description: DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee
arm group label: Dermabond group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Yong In, MD, PhD
role: Study Chair
affiliation: the Catholic Univerisity of Korea Seoul St Mary's hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Yong In
investigator title: Head of Orthopaedic Surgery
mesh term: Osteoarthritis, Knee
sharing ipd: No