<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/NCT03781206</url>
  </required_header>
  <id_info>
    <org_study_id>824</org_study_id>
    <nct_id>NCT03781206</nct_id>
  </id_info>
  <brief_title>Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal</brief_title>
  <acronym>NESTOR</acronym>
  <official_title>Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <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>
      Stoma reversal is associated with high incidence of post-surgical complications, including&#xD;
      Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully&#xD;
      applied to surgical wound management, reducing the SSIs incidence. This is a randomized&#xD;
      open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma&#xD;
      reversal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stoma reversal after abdominal resection is associated with several complications, of which&#xD;
      the most common is wound infection. Surgical Site Infections (SSI) usually result in&#xD;
      increased long-term complications, such as incisional hernia, prolonged hospital stay,&#xD;
      increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a&#xD;
      technique using vacuum dressing, commonly used to promote surgical wound healing, but there&#xD;
      is a significant lack of knowledge about its safety and efficacy in promoting wound healing&#xD;
      after stoma closure. This is an interventional, randomized, open label trial to evaluate the&#xD;
      safety and efficacy of the NPWT (PICO™ system, Smith&amp;Nephew Healthcare, Hull, UK) on stoma&#xD;
      wound compared to Standard of Care (SOC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 18, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site Infection (SSI) rate comparison</measure>
    <time_frame>Post-operative day 7</time_frame>
    <description>The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical Site Infection (SSI) rate comparison</measure>
    <time_frame>Post-operative day 30</time_frame>
    <description>The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound healing timing comparison</measure>
    <time_frame>Post-operative day 30</time_frame>
    <description>Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>Post-operative day 7</time_frame>
    <description>Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>Post-operative day 30</time_frame>
    <description>Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self) care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>Post-operative day 90</time_frame>
    <description>Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment</measure>
    <time_frame>Post-operative day 180</time_frame>
    <description>Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Post-operative day 7</time_frame>
    <description>Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Post-operative day 30</time_frame>
    <description>Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Post-operative day 90</time_frame>
    <description>Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment</measure>
    <time_frame>Post-operative day 180</time_frame>
    <description>Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stoma Site Infection</condition>
  <arm_group>
    <arm_group_label>Standard of Care (SOC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Negative Pressure Wound Therapy (NPWT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICO™ 7 will be applied after stoma reversal</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PICO™ 7</intervention_name>
    <description>PICO™ system (Smith&amp;Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.</description>
    <arm_group_label>Negative Pressure Wound Therapy (NPWT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years, any sex;&#xD;
&#xD;
          -  Patients who underwent elective open or laparoscopic rectal resection ostomy&#xD;
             construction (loop/end ileostomy; loop/end colostomy) for either oncological and&#xD;
             Inflammatory Bowel Disease (IBD) indications;&#xD;
&#xD;
          -  Normal water contrast enema prior to surgery;&#xD;
&#xD;
          -  Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;&#xD;
&#xD;
          -  Both immunosuppressant and biological medications are allowed for IBD patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients age at screening &lt; 18 years;&#xD;
&#xD;
          -  Pregnant or breastfeeding women;&#xD;
&#xD;
          -  Neurodegenerative disorders or psychiatric diseases;&#xD;
&#xD;
          -  Contraindications or hypersensitivity to the use of the investigational product or its&#xD;
             components;&#xD;
&#xD;
          -  Patients with skin features (e.g., tattoos, pre-existing scarring) which could&#xD;
             interfere with the study assessments;&#xD;
&#xD;
          -  Patients with post-operative bleeding (to be assessed 24 hours after surgery).&#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>Antonino Spinelli, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Annalisa Maroli, PhD</last_name>
    <phone>+39 02 8224 7776</phone>
    <email>annalisa.maroli@humanitas.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Humanitas Research Hospital</name>
      <address>
        <city>Rozzano</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Humanitas R Hospital</last_name>
      <phone>0282247776</phone>
      <email>annalisa.maroli@humanitas.it</email>
    </contact>
    <contact_backup>
      <phone_ext>Spinelli</phone_ext>
      <email>antonino.spinelli@humanitas.it</email>
    </contact_backup>
    <investigator>
      <last_name>Antonino Spinelli, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stoma</keyword>
  <keyword>Surgical Site Infection</keyword>
  <keyword>Negative Pressure Wound Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03781206
org study id: 824
nct id: NCT03781206
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Stoma reversal is associated with high incidence of post-surgical complications, including
      Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully
      applied to surgical wound management, reducing the SSIs incidence. This is a randomized
      open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma
      reversal.
Stoma reversal after abdominal resection is associated with several complications, of which
      the most common is wound infection. Surgical Site Infections (SSI) usually result in
      increased long-term complications, such as incisional hernia, prolonged hospital stay,
      increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a
      technique using vacuum dressing, commonly used to promote surgical wound healing, but there
      is a significant lack of knowledge about its safety and efficacy in promoting wound healing
      after stoma closure. This is an interventional, randomized, open label trial to evaluate the
      safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma
      wound compared to Standard of Care (SOC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Surgical Site Infection (SSI) rate comparison
time frame: Post-operative day 7
description: The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
measure: Surgical Site Infection (SSI) rate comparison
time frame: Post-operative day 30
description: The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
measure: Wound healing timing comparison
time frame: Post-operative day 30
description: Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
measure: Quality of life assessment
time frame: Post-operative day 7
description: Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: Quality of life assessment
time frame: Post-operative day 30
description: Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self) care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: Quality of life assessment
time frame: Post-operative day 90
description: Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: Quality of life assessment
time frame: Post-operative day 180
description: Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
measure: Pain assessment
time frame: Post-operative day 7
description: Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
measure: Pain assessment
time frame: Post-operative day 30
description: Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
measure: Pain assessment
time frame: Post-operative day 90
description: Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
measure: Pain assessment
time frame: Post-operative day 180
description: Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
arm group label: Standard of Care (SOC)
arm group type: No Intervention
description: After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.
arm group label: Negative Pressure Wound Therapy (NPWT)
arm group type: Experimental
description: PICO™ 7 will be applied after stoma reversal
intervention type: Device
intervention name: PICO™ 7
description: PICO™ system (Smith&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.
arm group label: Negative Pressure Wound Therapy (NPWT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antonino Spinelli, MD, PhD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
last name: Annalisa Maroli, PhD
phone: +39 02 8224 7776
email: annalisa.maroli@humanitas.it
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Italy
responsible party type: Sponsor
mesh term: Infections
sharing ipd: No