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/NCT06032949</url>
    </required_header>
    <id_info>
      <org_study_id>IRB202301216</org_study_id>
      <nct_id>NCT06032949</nct_id>
    </id_info>
    <brief_title>Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection</brief_title>
    <official_title>Vialize Use for the Reduction of Vascular Groin Incisional Dehiscence and Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Florida</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days,&#xD;
        resulting in reductions in patient quality of life and increased costs. Prior attempts at&#xD;
        reducing this complication rate have been largely unsuccessful. The purpose of this study is&#xD;
        to determine the feasibility of routine Vialize use for vascular surgeries involving a groin&#xD;
        incision and to determine the rates of surgical site infection/dehiscence in such patients&#xD;
        receiving subcutaneous Vialize.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>We will include patients from 2 populations: high-risk patients (any of the following: redo groin incision, active smoker, A1c &gt;/= 9.0, BMI &gt;/= 30) and non-high-risk patients.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.</measure>
      <time_frame>90-day post-op follow-up</time_frame>
      <description>Aim 1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The patient quality of life (EQ-5D)</measure>
      <time_frame>90-day post-op follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>return to OR for groin infection</measure>
      <time_frame>90-day post-op follow-up</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission or prolongation of the index admission for groin infection</measure>
      <time_frame>90-day post-op follow-up</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Groin Incisions, Vascular Disease, Groin Infections, Quality of Life, Readmission</condition>
    <arm_group>
      <arm_group_label>Vialize Arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients undergoing surgeries involving a groin incision will receive Vialize subcutaneously</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vialize</intervention_name>
      <description>To determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.</description>
      <arm_group_label>Vialize Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The study population will consist of patients undergoing vascular procedures with&#xD;
               groin incisions. Patients must be at least 18- years-old and able to complete baseline&#xD;
               measurements. All subjects will be compensated. Patients undergoing treatment for&#xD;
               peripheral arterial disease (e.g., femoropopliteal bypass), aneurysm disease (e.g.,&#xD;
               aortofemoral bypass), end-stage kidney disease (e.g., loop thigh graft), and&#xD;
               miscellaneous procedures (e.g., femoral exposure for delivery of device) will be&#xD;
               eligible.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing use of negative pressure wound therapy (e.g., Prevena) and local&#xD;
               antibiotic placement (e.g., vancomycin powder) will be excluded. Additionally,&#xD;
               organ-transplant recipients will be excluded.&#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>
    <overall_official>
      <last_name>Samir Shah, MD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tam Nguyen</last_name>
      <phone>352-273-5482</phone>
      <email>tam.nguyen@surgery.ufl.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nancy Hanson</last_name>
      <phone>352-273-5479</phone>
      <email>nancy.hanson@surgery.ufl.edu</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Vascular Diseases</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/NCT06032949
  org study id: IRB202301216
  nct id: NCT06032949
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Groin incisions in vascular surgery have complications in up to 30% of cases at 30 days,
        resulting in reductions in patient quality of life and increased costs. Prior attempts at
        reducing this complication rate have been largely unsuccessful. The purpose of this study is
        to determine the feasibility of routine Vialize use for vascular surgeries involving a groin
        incision and to determine the rates of surgical site infection/dehiscence in such patients
        receiving subcutaneous Vialize.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: We will include patients from 2 populations: high-risk patients (any of the following: redo groin incision, active smoker, A1c >/= 9.0, BMI >/= 30) and non-high-risk patients.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: The rate of infection at 90-day post-op follow-up in patients receiving Vialize during vascular surgeries involving a groin incision.
  time frame: 90-day post-op follow-up
  description: Aim 1
  measure: The patient quality of life (EQ-5D)
  time frame: 90-day post-op follow-up
  measure: return to OR for groin infection
  time frame: 90-day post-op follow-up
  measure: Readmission or prolongation of the index admission for groin infection
  time frame: 90-day post-op follow-up
  arm group label: Vialize Arm
  arm group type: Other
  description: Patients undergoing surgeries involving a groin incision will receive Vialize subcutaneously
  intervention type: Other
  intervention name: Vialize
  description: To determine the feasibility of routine Vialize use for vascular surgeries involving a groin incision and to determine the rates of surgical site infection/dehiscence in such patients receiving subcutaneous Vialize.
  arm group label: Vialize Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samir Shah, MD, MPH
  role: Principal Investigator
  affiliation: COLLEGE-MEDICINE MD-SURGERY MD-SURGERY-VASCULAR
  last name: Tam Nguyen
  phone: 352-273-5482
  email: tam.nguyen@surgery.ufl.edu
  last name: Nancy Hanson
  phone: 352-273-5479
  email: nancy.hanson@surgery.ufl.edu
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Vascular Diseases