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/NCT06006572</url>
    </required_header>
    <id_info>
      <org_study_id>CKRU2023-1674</org_study_id>
      <nct_id>NCT06006572</nct_id>
    </id_info>
    <brief_title>Hip DAA Closure Techniques</brief_title>
    <official_title>Direct Anterior Approach of the Hip and Variations in Wound Complications Using Different Closure Techniques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rothman Institute Orthopaedics</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rothman Institute Orthopaedics</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>
        This study aims to analyze the difference in rates of wound complications using two different&#xD;
        closure techniques in Direct anterior approach for primary total hip replacement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The use of the direct anterior approach (DAA) for primary total hip arthroplasty (THA) has&#xD;
        been increasingly popular but there has been a reported increased risk of wound complications&#xD;
        compared with a posterior approach. Wound complications can lead to increased length of stay,&#xD;
        reoperation procedures (i.e., irrigation and debridement), patient dissatisfaction, extra&#xD;
        visits, readmissions, increased risk of periprosthetic joint infection and overall increased&#xD;
        costs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wound complications</measure>
      <time_frame>90 days</time_frame>
      <description>Assessed using photographic documentation of the wound</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant satisfaction</measure>
      <time_frame>90 days</time_frame>
      <description>assessed using the POSAS (patient and observer scar assessment scale) questionnaire</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">172</enrollment>
    <condition>Total Hip Replacement</condition>
    <condition>Wound Complication</condition>
    <arm_group>
      <arm_group_label>wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive</description>
    </arm_group>
    <arm_group>
      <arm_group_label>wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive</intervention_name>
      <description>wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive</description>
      <arm_group_label>wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive</intervention_name>
      <description>wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive</description>
      <arm_group_label>wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years old that will undergo THA via DAA&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous hip arthroplasty surgeries or scars&#xD;
  &#xD;
            -  THA secondary to oncologic or traumatic etiologies&#xD;
  &#xD;
            -  BMI ≥ 40&#xD;
  &#xD;
            -  uncontrolled diabetes (measured by a Hgb A1c above 8)&#xD;
  &#xD;
            -  reported allergy to skin adhesive&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Rothman Orthopaedic Institute</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06006572
  org study id: CKRU2023-1674
  nct id: NCT06006572
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to analyze the difference in rates of wound complications using two different
        closure techniques in Direct anterior approach for primary total hip replacement.
  The use of the direct anterior approach (DAA) for primary total hip arthroplasty (THA) has
        been increasingly popular but there has been a reported increased risk of wound complications
        compared with a posterior approach. Wound complications can lead to increased length of stay,
        reoperation procedures (i.e., irrigation and debridement), patient dissatisfaction, extra
        visits, readmissions, increased risk of periprosthetic joint infection and overall increased
        costs.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Wound complications
  time frame: 90 days
  description: Assessed using photographic documentation of the wound
  measure: Participant satisfaction
  time frame: 90 days
  description: assessed using the POSAS (patient and observer scar assessment scale) questionnaire
  arm group label: wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive
  arm group type: Active Comparator
  description: After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive
  arm group label: wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
  arm group type: Active Comparator
  description: After surgery, the closure technique utilized by the surgeons will be wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
  intervention type: Procedure
  intervention name: wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive
  description: wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive
  arm group label: wound closure subcuticular running stitch using 3-0 monocryl suture without skin adhesive
  intervention type: Procedure
  intervention name: wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
  description: wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
  arm group label: wound closure subcuticular running stitch using 3-0 monocryl suture with two layers of skin adhesive
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor