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/NCT05977816</url>
    </required_header>
    <id_info>
      <org_study_id>RCSI 22-092</org_study_id>
      <nct_id>NCT05977816</nct_id>
    </id_info>
    <brief_title>PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds</brief_title>
    <acronym>PROPEL-2</acronym>
    <official_title>PROPEL-2 Prophylactic Negative Pressure Wound Therapy (NPWT) in Laparotomy Wounds: a Randomised Controlled Trial Comparing Negative Pressure Wound Therapy to Standard Wound Management in Patients Following Midline Laparotomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Royal College of Surgeons, Ireland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Royal College of Surgeons, Ireland</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Post-operative wound issues in abdominal surgery have a significant impact on patient&#xD;
        outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT)&#xD;
        dressings reduces Surgical Site Infections, post surgical complications and improves scar&#xD;
        appearance compared to standard dressings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might&#xD;
        reduce surgical site infections, improve wound healing and improve scar appearance compared&#xD;
        to using standard dressings.&#xD;
  &#xD;
        Data is limited in the application of NPWT dressings to laparotomy incisions in the acute and&#xD;
        elective care surgery setting. Surgical site infections can complicate a patient's&#xD;
        post-operative course significantly, often necessitating a longer length of stay, antibiotic&#xD;
        therapy, intervention for wound collections and impair patient mobility and overall recovery.&#xD;
  &#xD;
        In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and&#xD;
        also increases healthcare costs both as an inpatient and in the community. Despite&#xD;
        significant measures to reduce such complications in the form of wound care bundles, changing&#xD;
        of gloves prior to wound closure etc., surgical site complications continue to represent a&#xD;
        huge healthcare burden.&#xD;
  &#xD;
        The Investigators are conducting this study to determine whether NPWT dressings reduce&#xD;
        surgical site infections, improve wound healing and scar appearance. This study will also&#xD;
        involve a cost-based analysis and seek information from patients on their quality of life.&#xD;
        Results from this study will provide evidence on whether these dressings should be used as&#xD;
        standard of care for management of surgical laparotomy wounds.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 14, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>
      <intervention_model_description>Parallel Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of Surgical Site Infection (SSI)</measure>
      <time_frame>1 month following surgery</time_frame>
      <description>To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of Surgical Site Infection (SSI)</measure>
      <time_frame>3 months following surgery</time_frame>
      <description>To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of Surgical Site Infection (SSI)</measure>
      <time_frame>6 months following surgery</time_frame>
      <description>To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)</measure>
      <time_frame>Baseline</time_frame>
      <description>The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)</measure>
      <time_frame>1 month following surgery</time_frame>
      <description>The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)</measure>
      <time_frame>3 months following surgery</time_frame>
      <description>The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)</measure>
      <time_frame>6 months following surgery</time_frame>
      <description>The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)</measure>
      <time_frame>1 month following surgery</time_frame>
      <description>The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)</measure>
      <time_frame>3 months following surgery</time_frame>
      <description>The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)</measure>
      <time_frame>6 months following surgery</time_frame>
      <description>The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)</measure>
      <time_frame>1 month</time_frame>
      <description>The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)</measure>
      <time_frame>3 months</time_frame>
      <description>The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)</measure>
      <time_frame>6 months</time_frame>
      <description>The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings</measure>
      <time_frame>6 months</time_frame>
      <description>Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare incremental cost- utility ratio</measure>
      <time_frame>6 months</time_frame>
      <description>The incremental cost-effectiveness ratio at 6 months for NPWT vesus standard dressings for patients undergoing laparotomy.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Healthcare cost-effectiveness ratio at 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Assessment of the cost-effectiveness ratio at 6 months between NPWT dressings compared to standard dressings. The criteria of effectiveness used will be; Length of hospital stay, requirement for return to theatre, requirement for critical care and number of dressings used</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Wound Surgical</condition>
    <condition>Wound Infection</condition>
    <condition>Cosmesis</condition>
    <arm_group>
      <arm_group_label>Negative Pressure Wound Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The wound is dressed using negative pressure wound therapy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Wound dressing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the skin is closed, the wound is covered using sterile standard gauze dressing.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Negative Pressure Wound Therapy</intervention_name>
      <description>Application of a negative wound pressure therapy dressing to the wound post laparotomy</description>
      <arm_group_label>Negative Pressure Wound Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard wound dressing</intervention_name>
      <description>Application of a standard wound dressing to the wound post laparotomy</description>
      <arm_group_label>Standard Wound dressing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18 years or older&#xD;
  &#xD;
            -  Patient requires visceral abdominal surgery via a midline laparotomy&#xD;
  &#xD;
            -  Patients who can complete questionnaires&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Patients who are unable to adhere to protocol requirements&#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>Claire Donohoe, PhD, FRCSI</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trinity College Dublin /Royal College of Surgeons</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Claire Donohoe, PhD, FRCSI</last_name>
      <phone>35314103000</phone>
      <email>Cldonohoe@stjames.ie</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Noel Donlon, PhD</last_name>
      <phone>35314103000</phone>
      <email>donlonn@tcd.ie</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Portiuncula University Hospital</name>
        <address>
          <city>Ballinasloe</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Eddie Myers, MD AFRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mayo University Hospital</name>
        <address>
          <city>Castlebar</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Kevin Barry, MD FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Our Lady of Lourdes Hospital Drogheda</name>
        <address>
          <city>Drogheda</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Elanor Faul, BCh FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beaumont Hospital</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Arnold Hill, MCh MD FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mater Misericordiae University Hospital</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ronan Cahill, MD FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>St James's Hospital</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Claire Donohoe, PhD FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospital Galway</name>
        <address>
          <city>Galway</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sami Medani Abd ElWaheb, MBBS FRSCI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Letterkenny University Hospital</name>
        <address>
          <city>Letterkenny</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Manvydas Varzgalis, MCh MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospital Limerick</name>
        <address>
          <city>Limerick</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Christina Fleming, MCh PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sligo University Hospital</name>
        <address>
          <city>Sligo</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Martin Caldwell, MD FRCSI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University hospital Kerry</name>
        <address>
          <city>Tralee</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Pat Owens, MCh, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>University Hospital Waterford</name>
        <address>
          <city>Waterford</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Peter Neary, BAO FRCSI</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Negative Pressure Wound Therapy</keyword>
    <keyword>Surgical site Infection</keyword>
    <keyword>Laparotomy</keyword>
    <keyword>Post-operative Complications</keyword>
    <keyword>Abdominal Incision</keyword>
    <keyword>health economics</keyword>
    <keyword>POSAS</keyword>
    <keyword>CoPaQ</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wound Infection</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05977816
  org study id: RCSI 22-092
  nct id: NCT05977816
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Post-operative wound issues in abdominal surgery have a significant impact on patient
        outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT)
        dressings reduces Surgical Site Infections, post surgical complications and improves scar
        appearance compared to standard dressings.
  NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might
        reduce surgical site infections, improve wound healing and improve scar appearance compared
        to using standard dressings.
  
        Data is limited in the application of NPWT dressings to laparotomy incisions in the acute and
        elective care surgery setting. Surgical site infections can complicate a patient's
        post-operative course significantly, often necessitating a longer length of stay, antibiotic
        therapy, intervention for wound collections and impair patient mobility and overall recovery.
  
        In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and
        also increases healthcare costs both as an inpatient and in the community. Despite
        significant measures to reduce such complications in the form of wound care bundles, changing
        of gloves prior to wound closure etc., surgical site complications continue to represent a
        huge healthcare burden.
  
        The Investigators are conducting this study to determine whether NPWT dressings reduce
        surgical site infections, improve wound healing and scar appearance. This study will also
        involve a cost-based analysis and seek information from patients on their quality of life.
        Results from this study will provide evidence on whether these dressings should be used as
        standard of care for management of surgical laparotomy wounds.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Rate of Surgical Site Infection (SSI)
  time frame: 1 month following surgery
  description: To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
  measure: Rate of Surgical Site Infection (SSI)
  time frame: 3 months following surgery
  description: To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
  measure: Rate of Surgical Site Infection (SSI)
  time frame: 6 months following surgery
  description: To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
  measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
  time frame: Baseline
  description: The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
  measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
  time frame: 1 month following surgery
  description: The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
  measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
  time frame: 3 months following surgery
  description: The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
  measure: Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
  time frame: 6 months following surgery
  description: The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
  measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
  time frame: 1 month following surgery
  description: The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
  measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
  time frame: 3 months following surgery
  description: The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
  measure: Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
  time frame: 6 months following surgery
  description: The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
  measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
  time frame: 1 month
  description: The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
  measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
  time frame: 3 months
  description: The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
  measure: Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
  time frame: 6 months
  description: The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
  measure: Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
  time frame: 6 months
  description: Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings
  measure: Healthcare incremental cost- utility ratio
  time frame: 6 months
  description: The incremental cost-effectiveness ratio at 6 months for NPWT vesus standard dressings for patients undergoing laparotomy.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression
  measure: Healthcare cost-effectiveness ratio at 6 months
  time frame: 6 months
  description: Assessment of the cost-effectiveness ratio at 6 months between NPWT dressings compared to standard dressings. The criteria of effectiveness used will be; Length of hospital stay, requirement for return to theatre, requirement for critical care and number of dressings used
  arm group label: Negative Pressure Wound Therapy
  arm group type: Experimental
  description: The wound is dressed using negative pressure wound therapy.
  arm group label: Standard Wound dressing
  arm group type: Active Comparator
  description: After the skin is closed, the wound is covered using sterile standard gauze dressing.
  intervention type: Device
  intervention name: Negative Pressure Wound Therapy
  description: Application of a negative wound pressure therapy dressing to the wound post laparotomy
  arm group label: Negative Pressure Wound Therapy
  intervention type: Other
  intervention name: Standard wound dressing
  description: Application of a standard wound dressing to the wound post laparotomy
  arm group label: Standard Wound dressing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Claire Donohoe, PhD, FRCSI
  role: Principal Investigator
  affiliation: Trinity College Dublin /Royal College of Surgeons
  last name: Claire Donohoe, PhD, FRCSI
  phone: 35314103000
  email: Cldonohoe@stjames.ie
  last name: Noel Donlon, PhD
  phone: 35314103000
  email: donlonn@tcd.ie
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  country: Ireland
  responsible party type: Sponsor
  mesh term: Wound Infection
  mesh term: Wounds and Injuries
  mesh term: Surgical Wound
  sharing ipd: No