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/NCT06007599</url>
    </required_header>
    <id_info>
      <org_study_id>MAUS2023-2092</org_study_id>
      <nct_id>NCT06007599</nct_id>
    </id_info>
    <brief_title>Wound Healing in Primary TKA</brief_title>
    <official_title>Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA</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>
        Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific&#xD;
        factors, such as vascular or immune-related medical conditions, obesity, and smoking, among&#xD;
        others. The development of early wound complications can lead to increased length of hospital&#xD;
        stay and more serious complications, including deep infection and major subsequent surgery.&#xD;
        However, there are modifiable variables that could affect the risk of getting wound&#xD;
        complications, such as the closure technique. This study aims to analyze the difference in&#xD;
        rates of wound complications using two different closure techniques in primary TKA.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 16, 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>Patient 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">216</enrollment>
    <condition>Total Knee Replacement</condition>
    <condition>Wound Complication</condition>
    <arm_group>
      <arm_group_label>Group A: suture with 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 subcuticular running 3-0 monocryl sutures without skin adhesive</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B: 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 subcuticular running 3-0 monocryl sutures with skin adhesive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Skin closure using skin adhesive</intervention_name>
      <description>Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive</description>
      <arm_group_label>Group A: suture with skin adhesive</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Skin closure without skin adhesive</intervention_name>
      <description>Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive</description>
      <arm_group_label>Group B: suture without skin adhesive</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years old that will undergo primary TKA with a midline approach&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous knee arthroplasty surgeries or midline scars&#xD;
  &#xD;
            -  TKA 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;
  &#xD;
            -  immunodeficiencies&#xD;
  &#xD;
            -  bleeding disorders&#xD;
  &#xD;
            -  anticoagulation other than ASA&#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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_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/NCT06007599
  org study id: MAUS2023-2092
  nct id: NCT06007599
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific
        factors, such as vascular or immune-related medical conditions, obesity, and smoking, among
        others. The development of early wound complications can lead to increased length of hospital
        stay and more serious complications, including deep infection and major subsequent surgery.
        However, there are modifiable variables that could affect the risk of getting wound
        complications, such as the closure technique. This study aims to analyze the difference in
        rates of wound complications using two different closure techniques in primary TKA.
  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: Patient satisfaction
  time frame: 90 days
  description: Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
  arm group label: Group A: suture with skin adhesive
  arm group type: Active Comparator
  description: After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive
  arm group label: Group B: suture without skin adhesive
  arm group type: Active Comparator
  description: After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.
  intervention type: Procedure
  intervention name: Skin closure using skin adhesive
  description: Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
  arm group label: Group A: suture with skin adhesive
  intervention type: Procedure
  intervention name: Skin closure without skin adhesive
  description: Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive
  arm group label: Group B: suture without 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
  mesh term: Wounds and Injuries