<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/NCT03031314</url>
  </required_header>
  <id_info>
    <org_study_id>WHHSIJRR001</org_study_id>
    <nct_id>NCT03031314</nct_id>
  </id_info>
  <brief_title>Comparison of Knotless Barbed Suture and Standard Suture in Knee Replacement Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington Hospital Healthcare System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington Hospital Healthcare System</source>
  <brief_summary>
    <textblock>
      Barbed suture use has been gaining increased acceptance and has been reported to offer&#xD;
      potential advantages in wound closure of hip and knee replacement surgeries.&#xD;
&#xD;
      The goal of this study is to compare joint replacement patient outcomes who receive a&#xD;
      knotless barbed suture versus a traditional suture (randomized into two arms). The&#xD;
      traditional suture used at our joint replacement program is defined as: interrupted sutures&#xD;
      to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless&#xD;
      barbed suture and the traditional sutures have similar suture size.&#xD;
&#xD;
      Patient outcomes examined will be patient range of motion (recorded daily) and complications&#xD;
      with wound healing (evaluated periodically in-person at post-operative visits).&#xD;
&#xD;
      Secondary outcomes examined will include wound drainage on dressings by surface area and&#xD;
      weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of soft tissue infections</measure>
    <time_frame>12 weeks</time_frame>
    <description>evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>use of antibiotics to treat infection, recorded by number</measure>
    <time_frame>12 weeks</time_frame>
    <description>record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>measurement of incision drainage, measured in grams and mm surface area</measure>
    <time_frame>2 weeks</time_frame>
    <description>evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>assessment of quality of incision closure, recorded by time and number</measure>
    <time_frame>12 weeks</time_frame>
    <description>record delayed healing and reported by time, suture rejection based on number of episodes</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Standard suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard suture used (monocryl)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Barbed suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>barbed suture used (Quill suture, Surgical Specialties)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>barbed suture</intervention_name>
    <arm_group_label>Barbed suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standard suture</intervention_name>
    <arm_group_label>Standard suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary joint replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no prior joint surgery&#xD;
&#xD;
          -  no infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington Hospital Healthcare System</investigator_affiliation>
    <investigator_full_name>Alexander Sah, MD</investigator_full_name>
    <investigator_title>Physician and Research Chair, Institute for Joint Restoration and Research</investigator_title>
  </responsible_party>
  <keyword>Joint Replacement</keyword>
  <keyword>Knee Replacement</keyword>
  <keyword>Wound Healing</keyword>
  <keyword>Hip Replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <!-- 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/NCT03031314
org study id: WHHSIJRR001
nct id: NCT03031314
lead sponsor: 
Barbed suture use has been gaining increased acceptance and has been reported to offer
      potential advantages in wound closure of hip and knee replacement surgeries.

      The goal of this study is to compare joint replacement patient outcomes who receive a
      knotless barbed suture versus a traditional suture (randomized into two arms). The
      traditional suture used at our joint replacement program is defined as: interrupted sutures
      to close the retinaculum followed by running monocryl sutures for skin closure. Both knotless
      barbed suture and the traditional sutures have similar suture size.

      Patient outcomes examined will be patient range of motion (recorded daily) and complications
      with wound healing (evaluated periodically in-person at post-operative visits).

      Secondary outcomes examined will include wound drainage on dressings by surface area and
      weight, as well as the wound cosmesis and perceived presence of subcutaneous surgical knots.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Number of soft tissue infections
time frame: 12 weeks
description: evaluation of wound infection after surgery, number of patients with wound infection based on clinical examination
measure: use of antibiotics to treat infection, recorded by number
time frame: 12 weeks
description: record whether antibiotics used for suspicion or treatment of superficial infection, number of episodes recorded
measure: measurement of incision drainage, measured in grams and mm surface area
time frame: 2 weeks
description: evaluation of incision drainage based on dressing saturation size and weight, measured in grams for weight, and measured by surface area mm
measure: assessment of quality of incision closure, recorded by time and number
time frame: 12 weeks
description: record delayed healing and reported by time, suture rejection based on number of episodes
arm group label: Standard suture
arm group type: Active Comparator
description: standard suture used (monocryl)
arm group label: Barbed suture
arm group type: Active Comparator
description: barbed suture used (Quill suture, Surgical Specialties)
intervention type: Device
intervention name: barbed suture
arm group label: Barbed suture
intervention type: Device
intervention name: standard suture
arm group label: Standard suture
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Washington Hospital Healthcare System
investigator full name: Alexander Sah, MD
investigator title: Physician and Research Chair, Institute for Joint Restoration and Research
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip