<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/NCT03816293</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1300</org_study_id>
    <secondary_id>U01CK000557-01-00</secondary_id>
    <secondary_id>U01CK000557-01</secondary_id>
    <nct_id>NCT03816293</nct_id>
  </id_info>
  <brief_title>SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections</brief_title>
  <acronym>SUpPressSSI</acronym>
  <official_title>SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Acelity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our goal is to provide data that will give surgeons and hospitals clear recommendations on&#xD;
      the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients&#xD;
      with diabetes and/or obesity. We also want to understand the patient experience with the&#xD;
      dressing so that we can provide information that will enable clinicians to remove barriers to&#xD;
      NPWT use. Additionally, we are seeking to use automated electronic medical record decision&#xD;
      support to identify patients that will benefit most from the NPWT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: Evaluate the effect of single-use NPWT on SSI rates after C-section,&#xD;
      abdominal hysterectomy, and colon procedures in at risk patients.&#xD;
&#xD;
      To address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial&#xD;
      evaluating use of the PrevenaTM with 125 mm Hg negative pressure for 7 days among obese (BMI&#xD;
      &gt;30) and/or diabetic patients undergoing the procedures of interest. This is essentially a&#xD;
      phase IV clinical trial as this dressing has FDA approval for the indicated use.&#xD;
&#xD;
      Specific Aim 2: Investigate the patients' experience of using the NPWT. To achieve this aim,&#xD;
      we will survey a sub-set of patients to assess their knowledge of post-operative care, to&#xD;
      identify complications associated with NPWT use, and to learn how patients evaluated the&#xD;
      device's ease of use, ease of removal, and comfort.&#xD;
&#xD;
      Specific Aim 3: Assess whether real-time decision support through machine-learning modeling&#xD;
      can help surgeons identify patients at high risk of SSI who could benefit from NWPT or other&#xD;
      post-surgical preventive measures. To address this aim, we will evaluate whether boosted tree&#xD;
      modeling techniques can be used &quot;at the bedside&quot; via electronic medical record data feeds to&#xD;
      tailor post-operative care and preventive care for specific patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Randomized stepped wedge cluster but site</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site Infection Rate per 100 surgeries</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>Superficial , Deep and organ space infections after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Operative Length of Stay (days)</measure>
    <time_frame>within 30days after surgery</time_frame>
    <description>days of ongoing admission after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>REadmission incidence and rate per 100 surgeries</measure>
    <time_frame>within 30 days</time_frame>
    <description>REadmission to hospital after discharge from surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroma incidence and rate per 100 surgeries</measure>
    <time_frame>with in 30 days after surgery</time_frame>
    <description>Non infectious Fluid accumulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma incidence and rate per 100 surgeries</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>Bloody fluid collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dehiscence incidence and rate per 100 surgeries</measure>
    <time_frame>within 30 days after surgery</time_frame>
    <description>Loss of incision apposition</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3680</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <condition>Cesarean Section Complications</condition>
  <arm_group>
    <arm_group_label>Negative Pressure Wound Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Dressing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative Pressure Wound Therapy</intervention_name>
    <description>Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions</description>
    <arm_group_label>Negative Pressure Wound Therapy</arm_group_label>
    <other_name>Prevena Incision Management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Category A and B&#xD;
&#xD;
        A. Patients undergoing any of the below procedures:&#xD;
&#xD;
          1. C-section&#xD;
&#xD;
          2. abdominal hysterectomy&#xD;
&#xD;
          3. colon procedures Surgical procedures selected will be based on NHSN designated ICD-10&#xD;
             PCS codes(14), with the exclusion of laparoscopic procedures.&#xD;
&#xD;
        B. and either of the following medical conditions:&#xD;
&#xD;
          1. obesity, BMI &gt;30 kg/m2&#xD;
&#xD;
          2. diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the&#xD;
             problem list or the medical history or Patient is taking a medication as treatment for&#xD;
             diabetes, consistent with NHSN criteria(10).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Infection present at the time of the surgery&#xD;
&#xD;
          3. Laparoscopic procedures with incisions &lt;6cm.&#xD;
&#xD;
          4. Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg&#xD;
             negative pressure&#xD;
&#xD;
          5. Prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Bleasdale, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Illinois Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Health System</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Susan Casey Bleasdale</investigator_full_name>
    <investigator_title>Associate Professor of Clinical Medicine</investigator_title>
  </responsible_party>
  <keyword>colon surgery</keyword>
  <keyword>abdominal hysterectomy</keyword>
  <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>Surgical Wound Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a study with waiver of consent data will be in aggregate without patient identifiers</ipd_description>
  </patient_data>
  <!-- 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/NCT03816293
org study id: 2018-1300
secondary id: U01CK000557-01-00
secondary id: U01CK000557-01
nct id: NCT03816293
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Our goal is to provide data that will give surgeons and hospitals clear recommendations on
      the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients
      with diabetes and/or obesity. We also want to understand the patient experience with the
      dressing so that we can provide information that will enable clinicians to remove barriers to
      NPWT use. Additionally, we are seeking to use automated electronic medical record decision
      support to identify patients that will benefit most from the NPWT.
Specific Aim 1: Evaluate the effect of single-use NPWT on SSI rates after C-section,
      abdominal hysterectomy, and colon procedures in at risk patients.

      To address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial
      evaluating use of the PrevenaTM with 125 mm Hg negative pressure for 7 days among obese (BMI
      >30) and/or diabetic patients undergoing the procedures of interest. This is essentially a
      phase IV clinical trial as this dressing has FDA approval for the indicated use.

      Specific Aim 2: Investigate the patients' experience of using the NPWT. To achieve this aim,
      we will survey a sub-set of patients to assess their knowledge of post-operative care, to
      identify complications associated with NPWT use, and to learn how patients evaluated the
      device's ease of use, ease of removal, and comfort.

      Specific Aim 3: Assess whether real-time decision support through machine-learning modeling
      can help surgeons identify patients at high risk of SSI who could benefit from NWPT or other
      post-surgical preventive measures. To address this aim, we will evaluate whether boosted tree
      modeling techniques can be used "at the bedside" via electronic medical record data feeds to
      tailor post-operative care and preventive care for specific patients.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Randomized stepped wedge cluster but site
primary purpose: Prevention
masking: None (Open Label)
measure: Surgical Site Infection Rate per 100 surgeries
time frame: within 30 days after surgery
description: Superficial , Deep and organ space infections after surgery
measure: Post Operative Length of Stay (days)
time frame: within 30days after surgery
description: days of ongoing admission after surgery
measure: REadmission incidence and rate per 100 surgeries
time frame: within 30 days
description: REadmission to hospital after discharge from surgery
measure: Seroma incidence and rate per 100 surgeries
time frame: with in 30 days after surgery
description: Non infectious Fluid accumulation
measure: Hematoma incidence and rate per 100 surgeries
time frame: within 30 days after surgery
description: Bloody fluid collection
measure: Dehiscence incidence and rate per 100 surgeries
time frame: within 30 days after surgery
description: Loss of incision apposition
arm group label: Negative Pressure Wound Therapy
arm group type: Active Comparator
description: NPWT use on closed incision for 7 days after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity
arm group label: Control Dressing
arm group type: No Intervention
description: Standard dressing on closed incisions after c-section, abdominal hysterectomy, and colon surgery in patients with diabetes and/or obesity
intervention type: Device
intervention name: Negative Pressure Wound Therapy
description: Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions
arm group label: Negative Pressure Wound Therapy
other name: Prevena Incision Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan Bleasdale, MD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Susan Casey Bleasdale
investigator title: Associate Professor of Clinical Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
sharing ipd: No
ipd description: This is a study with waiver of consent data will be in aggregate without patient identifiers