<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/NCT02255877</url>
  </required_header>
  <id_info>
    <org_study_id>005</org_study_id>
    <nct_id>NCT02255877</nct_id>
  </id_info>
  <brief_title>ZIPS Study - Zip Incision Approximation vs. STAPLE</brief_title>
  <acronym>ZIPS</acronym>
  <official_title>A Prospective, Non Blinded, Randomized Controlled Post Market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device vs. Conventional Steel Staples for Skin Closure in Subjects Who Undergo a bi Lateral Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ZipLine Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ZipLine Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel&#xD;
      staple placement when utilized for surgical wound closure after bi lateral unicompartmental&#xD;
      or bi later total knee replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, within patient control study aiming to enroll up to 25 subjects&#xD;
      requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center.&#xD;
      Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and&#xD;
      overall satisfaction of closure methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in research plan&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness Outcome - Wound Healing</measure>
    <time_frame>6 weeks post surgery</time_frame>
    <description>Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon Satisfaction with the Closure Method</measure>
    <time_frame>At Discharge, 1-3 days post surgery</time_frame>
    <description>Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Pain</measure>
    <time_frame>Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)</time_frame>
    <description>General post operative and incisional pain levels will be collected using a 10 point VAS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction of Scars</measure>
    <time_frame>At 6 week Follow up (exit) visit</time_frame>
    <description>Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <arm_group>
    <arm_group_label>Zip Surgical Skin Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steel Staples</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zip Surgical Skin Closure</intervention_name>
    <description>Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.</description>
    <arm_group_label>Steel Staples</arm_group_label>
    <arm_group_label>Zip Surgical Skin Closure</arm_group_label>
    <other_name>Zip 16</other_name>
    <other_name>Zip 8i</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Steel Staples</intervention_name>
    <description>Skin Closure device for the closure of the skin layer for surgical incisions.</description>
    <arm_group_label>Steel Staples</arm_group_label>
    <arm_group_label>Zip Surgical Skin Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients requiring epidermal closure after bi lateral total or partial&#xD;
             (unicompartmental) knee arthroplasty;&#xD;
&#xD;
          -  Patients willing to be evaluated at discharge and 6-weeks post op.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known bleeding disorder not caused by medication&#xD;
&#xD;
          -  Known personal or family history of keloid formation or scar hypertrophy&#xD;
&#xD;
          -  Known allergy or hypersensitivity to non-latex skin adhesives&#xD;
&#xD;
          -  Atrophic skin deemed clinically prone to blistering&#xD;
&#xD;
          -  Any skin disorder affecting wound healing&#xD;
&#xD;
          -  Any other condition that in the opinion of the investigator would make a particular&#xD;
             patient unsuitable for this study&#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>Eric Storne</last_name>
    <role>Study Director</role>
    <affiliation>VP Marketing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Orthopaedic Research Foundation</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46278</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>October 21, 2016</last_update_submitted>
  <last_update_submitted_qc>October 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bi lateral knee surgery</keyword>
  <keyword>uni compartmental</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/NCT02255877
org study id: 005
nct id: NCT02255877
lead sponsor: 
has dmc: No
Study designed to evaluate the Zip Surgical Skin Closure device versus conventional steel
      staple placement when utilized for surgical wound closure after bi lateral unicompartmental
      or bi later total knee replacement.
This is a randomized, within patient control study aiming to enroll up to 25 subjects
      requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center.
      Subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and
      overall satisfaction of closure methods.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness Outcome - Wound Healing
time frame: 6 weeks post surgery
description: Wound healing as judged by the Cosmetic Visual Analogue Scale - Photos taken at 6 weeks post surgery will be judged by panel of Plastic Surgeons blinded to the treatment assignments.
measure: Surgeon Satisfaction with the Closure Method
time frame: At Discharge, 1-3 days post surgery
description: Closure Method satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied)
measure: Patient Pain
time frame: Throughout 6 week study period (Discharge, 2 week follow up and 6 week follow up (exit) visits.)
description: General post operative and incisional pain levels will be collected using a 10 point VAS scale
measure: Patient Satisfaction of Scars
time frame: At 6 week Follow up (exit) visit
description: Scar satisfaction (Zip and Staple) will be collected with a 5 point satisfaction scale (from very satisfied to very dissatisfied) and with a 10 point VAS scale
arm group label: Zip Surgical Skin Closure
arm group type: Active Comparator
description: Subjects randomized to receive one knee (left or right) closed with ZipSurgical Skin Closure and the other knee closed with standard staples
arm group label: Steel Staples
arm group type: Active Comparator
description: Subjects randomized to receive one knee (left or right) closed with Staples and the other knee closed with ZipSurgical Skin Closure
intervention type: Device
intervention name: Zip Surgical Skin Closure
description: Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
arm group label: Steel Staples
arm group label: Zip Surgical Skin Closure
other name: Zip 16
other name: Zip 8i
intervention type: Device
intervention name: Steel Staples
description: Skin Closure device for the closure of the skin layer for surgical incisions.
arm group label: Steel Staples
arm group label: Zip Surgical Skin Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Storne
role: Study Director
affiliation: VP Marketing
facility: 
country: United States
responsible party type: Sponsor