xml: <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/NCT05972603</url>
    </required_header>
    <id_info>
      <org_study_id>1234</org_study_id>
      <nct_id>NCT05972603</nct_id>
    </id_info>
    <brief_title>Role of Topical Vancomycin in Reducing Infections in Hip and Knee Arthroplasty</brief_title>
    <official_title>Can Topical Vancomycin Prevent Periprosthetic Joint Infection in Primary Hip and Knee Arthroplasty? Multicenter Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Independent Public Healthcare Center in Rypin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Independent Public Healthcare Center in Rypin</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine&#xD;
        lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and&#xD;
        Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction&#xD;
        of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted&#xD;
        povidone-iodine (PI) protocol.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine&#xD;
        (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.&#xD;
  &#xD;
        Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder&#xD;
        into the wound around the prosthesis and no suction will be used.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>periprosthetic joint infection</measure>
      <time_frame>90 days</time_frame>
      <description>infection rate in each group</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Osteoarthritis, Knee</condition>
    <condition>Osteoarthritis, Hip</condition>
    <condition>Rheumatoid Arthritis</condition>
    <condition>Avascular Necrosis of Hip</condition>
    <arm_group>
      <arm_group_label>0,35% povidone-iodine solution lavage</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>1.0 g Vancomycin powder into the wound</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>additional 1.0 g Vancomycin powder into the wound</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>1.0 g Vancomycin powder into the wound</intervention_name>
      <description>0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound</description>
      <arm_group_label>1.0 g Vancomycin powder into the wound</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>0,35% povidone-iodine solution lavage</intervention_name>
      <description>0,35% povidone-iodine solution lavage left for 3 minutes following final implantation</description>
      <arm_group_label>0,35% povidone-iodine solution lavage</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  undergoing THA or TKA as a result of osteoarthritis or rheumatoid arthritis, can&#xD;
               understand and comply with the study protocol, have signed the informed consent&#xD;
               document at screening&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients referred to the hospital in order to undergo THA or TKA due to different&#xD;
               reason than osteoarthritis, rheumatoid arthritis or avascular necrosis of the femoral&#xD;
               head, such as: failed femoral neck fractures, displaced acetabular fractures or&#xD;
               revision acetabular fractures, revision knee or hip arthroplasty&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>IPHC Rypin</name>
        <address>
          <city>Rypin</city>
          <state>Kujawsko-pomorksie</state>
          <zip>87-500</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Karol Elster, Md Phd</last_name>
        <phone>+48662128773</phone>
        <email>karol.elster@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
      <mesh_term>Osteoarthritis, Hip</mesh_term>
      <mesh_term>Necrosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vancomycin</mesh_term>
      <mesh_term>Povidone-Iodine</mesh_term>
      <mesh_term>Povidone</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05972603
  org study id: 1234
  nct id: NCT05972603
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The study is designed to assess the efficacy of vancomycin powder and dilute povidone-iodine
        lavage (VIP protocol) in reducing the PJI after primary Total Hip Arthroplasty (THA) and
        Total Knee Arthroplasty (TKA). We hypothesized that VIP protocol provides superior reduction
        of periprosthetic joint infection (PJI) rates after primary THA and TKA compared with diluted
        povidone-iodine (PI) protocol.
  Patients who undergo primary hip or knee arthroplasty, before closure 0,35% povidone-iodine
        (17,5mL in 500 mL saline) solution lavage left for 3 minutes following final implantation.
  
        Patients drawn by random numbers calculator will be administered with 1.0 g Vancomycin powder
        into the wound around the prosthesis and no suction will be used.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: periprosthetic joint infection
  time frame: 90 days
  description: infection rate in each group
  arm group label: 0,35% povidone-iodine solution lavage
  arm group type: Experimental
  description: 0,35% povidone-iodine solution lavage left in wound for 3 minutes following final implantation.
  arm group label: 1.0 g Vancomycin powder into the wound
  arm group type: Experimental
  description: additional 1.0 g Vancomycin powder into the wound
  intervention type: Procedure
  intervention name: 1.0 g Vancomycin powder into the wound
  description: 0,35% povidone-iodine solution lavage left for 3 minutes following final implantation and additional application 1.0 g Vancomycin powder into the wound
  arm group label: 1.0 g Vancomycin powder into the wound
  intervention type: Procedure
  intervention name: 0,35% povidone-iodine solution lavage
  description: 0,35% povidone-iodine solution lavage left for 3 minutes following final implantation
  arm group label: 0,35% povidone-iodine solution lavage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  mesh term: Osteoarthritis, Hip
  mesh term: Necrosis
  mesh term: Vancomycin
  mesh term: Povidone-Iodine
  mesh term: Povidone