<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/NCT02235363</url>
  </required_header>
  <id_info>
    <org_study_id>Thread Lift</org_study_id>
    <nct_id>NCT02235363</nct_id>
  </id_info>
  <brief_title>Thread Lift by Use of Retaining Ligaments</brief_title>
  <acronym>TL</acronym>
  <official_title>Thread Lift by Use of Retaining Ligaments With V-lock Barbed Sutures : Under the Condition of Using the Tensiometer and FACE-Q</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winners Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winners Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars&#xD;
      with desired results. Especially to improve the jowls and nasolabial folds, the thread lift&#xD;
      is a simple and inexpensive technique for patients who do not wish to undergo the typical&#xD;
      facelift surgery, but the weak points of it are less effective and shorter duration than the&#xD;
      conventional facelift.The investigators propose the new method of the thread lifting the&#xD;
      subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments&#xD;
      with two fixation points on both temporal fascia and retaining ligaments. For the&#xD;
      intraoperative evaluation the tensiometer was applied and for the postoperative evaluation&#xD;
      the FACE-Q applied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars&#xD;
      with desired results. Especially to improve the jowls and nasolabial folds, the thread lift&#xD;
      is a simple and inexpensive technique for patients who do not wish to undergo the typical&#xD;
      facelift surgery, but the weak points of it are less effective and shorter duration than the&#xD;
      conventional facelift.The investigators propose the new method of the thread lifting the&#xD;
      subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments.&#xD;
&#xD;
      Retrospective analysis was performed on 369 consecutive patients undergoing the suture&#xD;
      suspension technique between January of 2012 and December of 2015, so called thread lift,&#xD;
      using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial&#xD;
      procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively,&#xD;
      with a mean of 34.3 months. There are asymmetry(n=2), scar revision(n=1), revision(n=4),&#xD;
      dimpling(n=1), suboptimal outcomes(n=9), and stitch abscess(n=1). The thread lift by use of&#xD;
      the retaining ligaments with V-lock barbed sutures can be recommended as an alternative&#xD;
      technique in the facelift.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>369 consecutive patients underwent the suture suspension technique, so called thread lift, using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively, with a mean of 34.3 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Revision or reoperation</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Checking whether revision was done by patients' need or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Suboptimal outcomes</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Checking whether patients were satisfied with the postoperative outcomes of their faces or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asymmetry</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Comparing the degree of sagging of the right and left faces to see if there is any difference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scar revision</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Checking whether scar revision was done due to hypertrophic scar on the operative sites or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dimpling</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Checking whether patients complained about dimpling on the operation sites of their faces or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stitch abscess</measure>
    <time_frame>3 and 6 months</time_frame>
    <description>Checking whether the operative sites were infected or not.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">369</enrollment>
  <condition>Face Lift</condition>
  <condition>Suspension Technique</condition>
  <condition>Minimal Invasive Surgery</condition>
  <arm_group>
    <arm_group_label>facelift</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>thread lift</intervention_name>
    <description>In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.</description>
    <arm_group_label>facelift</arm_group_label>
    <other_name>suspension technique with V-Loc barbed sutures</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary case&#xD;
&#xD;
          -  secondary case&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  wide scar tissue on face&#xD;
&#xD;
          -  allergy to foreign body(thread)&#xD;
&#xD;
          -  no skin excess&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHEOLHWAN KIM, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winners Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Department of Plastic Surgery, Winners Clinic</name>
      <address>
        <city>Seoul</city>
        <zip>135-893</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Sasaki GH, Cohen AT. Meloplication of the malar fat pads by percutaneous cable-suture technique for midface rejuvenation: outcome study (392 cases, 6 years' experience). Plast Reconstr Surg. 2002 Aug;110(2):635-54; discussion 655-7. doi: 10.1097/00006534-200208000-00042.</citation>
    <PMID>12142689</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>face lift</keyword>
  <keyword>thread lift</keyword>
  <keyword>retaining ligament</keyword>
  <keyword>V-Loc sutures</keyword>
  <keyword>tensiometer</keyword>
  <keyword>FACE-Q</keyword>
  <!-- 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/NCT02235363
org study id: Thread Lift
nct id: NCT02235363
lead sponsor: 
has dmc: No
In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars
      with desired results. Especially to improve the jowls and nasolabial folds, the thread lift
      is a simple and inexpensive technique for patients who do not wish to undergo the typical
      facelift surgery, but the weak points of it are less effective and shorter duration than the
      conventional facelift.The investigators propose the new method of the thread lifting the
      subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments
      with two fixation points on both temporal fascia and retaining ligaments. For the
      intraoperative evaluation the tensiometer was applied and for the postoperative evaluation
      the FACE-Q applied.
In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars
      with desired results. Especially to improve the jowls and nasolabial folds, the thread lift
      is a simple and inexpensive technique for patients who do not wish to undergo the typical
      facelift surgery, but the weak points of it are less effective and shorter duration than the
      conventional facelift.The investigators propose the new method of the thread lifting the
      subdermal and subcutaneous layer with a fiberoptic needle by use of the retaining ligaments.

      Retrospective analysis was performed on 369 consecutive patients undergoing the suture
      suspension technique between January of 2012 and December of 2015, so called thread lift,
      using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial
      procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively,
      with a mean of 34.3 months. There are asymmetry(n=2), scar revision(n=1), revision(n=4),
      dimpling(n=1), suboptimal outcomes(n=9), and stitch abscess(n=1). The thread lift by use of
      the retaining ligaments with V-lock barbed sutures can be recommended as an alternative
      technique in the facelift.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 369 consecutive patients underwent the suture suspension technique, so called thread lift, using 3-0 V-Loc 180 device for facial rejuvenation with (n=305) or without additional facial procedures (n=64). The follow-up period ranged from 22 months to 43 months postoperatively, with a mean of 34.3 months.
primary purpose: Treatment
masking: None (Open Label)
measure: Revision or reoperation
time frame: 3 and 6 months
description: Checking whether revision was done by patients' need or not.
measure: Suboptimal outcomes
time frame: 3 and 6 months
description: Checking whether patients were satisfied with the postoperative outcomes of their faces or not.
measure: Asymmetry
time frame: 3 and 6 months
description: Comparing the degree of sagging of the right and left faces to see if there is any difference.
measure: Scar revision
time frame: 3 and 6 months
description: Checking whether scar revision was done due to hypertrophic scar on the operative sites or not.
measure: Dimpling
time frame: 3 and 6 months
description: Checking whether patients complained about dimpling on the operation sites of their faces or not.
measure: Stitch abscess
time frame: 3 and 6 months
description: Checking whether the operative sites were infected or not.
arm group label: facelift
arm group type: Experimental
description: In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.
intervention type: Procedure
intervention name: thread lift
description: In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.
arm group label: facelift
other name: suspension technique with V-Loc barbed sutures
criteria: 
gender: All
minimum age: 23 Years
maximum age: 76 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CHEOLHWAN KIM, M.D.
role: Principal Investigator
affiliation: Winners Clinic
facility: 
country: Korea, Republic of
citation: Sasaki GH, Cohen AT. Meloplication of the malar fat pads by percutaneous cable-suture technique for midface rejuvenation: outcome study (392 cases, 6 years' experience). Plast Reconstr Surg. 2002 Aug;110(2):635-54; discussion 655-7. doi: 10.1097/00006534-200208000-00042.
PMID: 12142689
responsible party type: Sponsor