<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/NCT04488666</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01</org_study_id>
    <nct_id>NCT04488666</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of a Novel Incisional NPWT System</brief_title>
  <official_title>A Clinical Evaluation of a Novel, Single-Use, Negative Pressure Wound Therapy (NPWT) System for the Management of Closed Surgical Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aatru Medical LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NAMSA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aatru Medical LLC</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the&#xD;
      suitability, safety and efficacy of the system for the management of closed surgical wounds&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this investigation is to test the functionality of a novel, non-electric NPWT&#xD;
      device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC&#xD;
      (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air&#xD;
      contained within the dressing (air contains 21% O2) and hence bring and maintain the system&#xD;
      to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the&#xD;
      chemical reaction pump module can be manufactured for significantly less than the cost of&#xD;
      electromechanical NPWT systems and can be profitably marketed at a discount to the cost of&#xD;
      existing commercial devices. The Aatru Medical NPWT system could transform the economics and&#xD;
      increase the availability of this therapy across the world.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 26, 2021</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean (median) number of days of negative pressure delivered to the incision up to day 7</measure>
    <time_frame>7 days</time_frame>
    <description>To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.</measure>
    <time_frame>7 Days</time_frame>
    <description>5 is excellent exudate management; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) days wear time of the adhesive dressing up to day 7</measure>
    <time_frame>7 days</time_frame>
    <description>To assess the wear time of the adhesive dressing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) days longevity of the chemical vacuum source up to day 7</measure>
    <time_frame>7 Days</time_frame>
    <description>To assess the longevity of the chemical vacuum source</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of blisters on day 7 ±2</measure>
    <time_frame>7 days</time_frame>
    <description>Condition of the peri wound skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.</measure>
    <time_frame>14 days</time_frame>
    <description>To assess the appearance of the closed incision and scar. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.</measure>
    <time_frame>30 Days</time_frame>
    <description>Assess the Frequency of Surgical site infections. A higher ASEPSIS score indicates impaired wound healing (a score of &gt;10 indicates an increasing probability and severity of infection)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) wound pain score using a 0 -10 NRS (numerical rating score) by the study participant each day up to day 7±2. 10 is worst imaginable pain; 0 is no pain.</measure>
    <time_frame>7 days</time_frame>
    <description>To assess wound pain daily in the 7 day post-operative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events (non-device related, and device related) up to day30 ±2</measure>
    <time_frame>30 Days</time_frame>
    <description>To assess the occurrence of adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) ease of use score from patients on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate</measure>
    <time_frame>7 days To assess the ease of use by patients assessments</time_frame>
    <description>To assess the ease of use by patients assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) ease of use score from clinicians on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate</measure>
    <time_frame>7 days</time_frame>
    <description>To assess the ease of use by clinicians assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean (median) score of overall clinician acceptability of the NPWT system (pump &amp; dressing) on 5-point NRS assessed at day 14 ±2. 5 is Excellent incision management system; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate</measure>
    <time_frame>14 days</time_frame>
    <description>To assess overall clinician acceptability of the NPWT system</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Surgical Wound</condition>
  <arm_group>
    <arm_group_label>npSIMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group will receive the Aatru Medical npSIMS device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>npSIMS</intervention_name>
    <description>incisional NPWT</description>
    <arm_group_label>npSIMS</arm_group_label>
    <other_name>negative pressure Surgical Incision Management system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Participant is male or female ≥ 18 years of age 2. Participant will undergo an elective&#xD;
        sternotomy, thoracotomy, caesarean section (C-section) or skin surgery incision with&#xD;
        closure by sutures or staples 3. Participant will undergo a surgical procedure resulting in&#xD;
        a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that&#xD;
        the npSIMS dressing covers the wound with a minimum of 1 cm overlap at each end 4.&#xD;
        Participant is willing and able to take part in the study and provide written informed&#xD;
        consent.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants will undergo post-surgical radiotherapy or chemotherapy&#xD;
&#xD;
          2. Participants who, in the opinion of the Investigator, have an existing health&#xD;
             condition that would compromise their participation and follow-up in this study&#xD;
&#xD;
          3. Participant will undergo emergency surgery&#xD;
&#xD;
          4. Participant is sensitive to or known to have allergies to silicone/acrylic adhesives&#xD;
&#xD;
          5. Participant has malignancy in the wound bed or margins of the wound&#xD;
&#xD;
          6. Participant has wound with confirmed and untreated osteomyelitis&#xD;
&#xD;
          7. Participant has wound with non-enteric and unexplored fistulas&#xD;
&#xD;
          8. Participant has wound with necrotic tissue with eschar present&#xD;
&#xD;
          9. Participant has exposed arteries, veins, nerves or organs&#xD;
&#xD;
         10. Participant has exposed anastomotic sites&#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>Jon Mathy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Robin Martin, PhD</last_name>
    <phone>447736736752</phone>
    <email>robin@robinmartinphd.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Middlemore Clinical Trials</name>
      <address>
        <city>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kate Msiska</last_name>
      <phone>+64 9 276 0044</phone>
      <phone_ext>56828</phone_ext>
      <email>kate.msiska@mmclintrials.nz</email>
    </contact>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>incisional NPWT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- 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/NCT04488666
org study id: 2020-01
nct id: NCT04488666
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A study of the first clinical use in humans of a novel NPWT system (npSIMS) to assess the
      suitability, safety and efficacy of the system for the management of closed surgical wounds
The purpose of this investigation is to test the functionality of a novel, non-electric NPWT
      device: npSIMS (negative pressure Surgical Incision Management System) from Aatru Medical LLC
      (Ohio, USA) which uses an exothermic chemical process to extract the oxygen from the air
      contained within the dressing (air contains 21% O2) and hence bring and maintain the system
      to between -160 and -80 mmHg below atmospheric pressure (760 mmHg). The dressing and the
      chemical reaction pump module can be manufactured for significantly less than the cost of
      electromechanical NPWT systems and can be profitably marketed at a discount to the cost of
      existing commercial devices. The Aatru Medical NPWT system could transform the economics and
      increase the availability of this therapy across the world.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean (median) number of days of negative pressure delivered to the incision up to day 7
time frame: 7 days
description: To assess the maintenance and reliability with which negative pressure is delivered for the 7-day NPWT period.
measure: Mean (median) clinician assessment of exudate management on 5-point Numerical Rating Score (NRS) at day 7 ±2 and at any npSIMS replacement.
time frame: 7 Days
description: 5 is excellent exudate management; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
measure: Mean (median) days wear time of the adhesive dressing up to day 7
time frame: 7 days
description: To assess the wear time of the adhesive dressing
measure: Mean (median) days longevity of the chemical vacuum source up to day 7
time frame: 7 Days
description: To assess the longevity of the chemical vacuum source
measure: Presence or absence of blisters on day 7 ±2
time frame: 7 days
description: Condition of the peri wound skin
measure: Mean (median) overall observer and participant scores in the POSAS - Patient Observer Scar Assessment Scale on day 14 ±2 clinic follow up.
time frame: 14 days
description: To assess the appearance of the closed incision and scar. Each item of the POSAS is rated on a 10-point score. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 10 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation)
measure: Frequency of surgical wound complications according to the ASEPSIS wound score at day 14 ±2 clinic and day 30±2 remote follow up.
time frame: 30 Days
description: Assess the Frequency of Surgical site infections. A higher ASEPSIS score indicates impaired wound healing (a score of >10 indicates an increasing probability and severity of infection)
measure: Mean (median) wound pain score using a 0 -10 NRS (numerical rating score) by the study participant each day up to day 7±2. 10 is worst imaginable pain; 0 is no pain.
time frame: 7 days
description: To assess wound pain daily in the 7 day post-operative period
measure: Frequency of adverse events (non-device related, and device related) up to day30 ±2
time frame: 30 Days
description: To assess the occurrence of adverse events
measure: Mean (median) ease of use score from patients on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
time frame: 7 days To assess the ease of use by patients assessments
description: To assess the ease of use by patients assessments
measure: Mean (median) ease of use score from clinicians on 5-point NRS (numerical rating score) assessed at day 7 ±2. 5 is excellent ease of use; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
time frame: 7 days
description: To assess the ease of use by clinicians assessments
measure: Mean (median) score of overall clinician acceptability of the NPWT system (pump & dressing) on 5-point NRS assessed at day 14 ±2. 5 is Excellent incision management system; 4 is good; 3 is adequate; 2 is poor; 1 is inadequate
time frame: 14 days
description: To assess overall clinician acceptability of the NPWT system
arm group label: npSIMS
arm group type: Experimental
description: Group will receive the Aatru Medical npSIMS device
intervention type: Device
intervention name: npSIMS
description: incisional NPWT
arm group label: npSIMS
other name: negative pressure Surgical Incision Management system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jon Mathy, MD
role: Principal Investigator
affiliation: 1Auckland Regional Plastic Surgery Unit and University of Auckland School of Medicine
last name: Robin Martin, PhD
phone: 447736736752
email: robin@robinmartinphd.com
facility: 
status: Recruiting
contact: 
country: New Zealand
responsible party type: Sponsor
mesh term: Surgical Wound