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/NCT06025253</url>
    </required_header>
    <id_info>
      <org_study_id>RCSI-PINTA</org_study_id>
      <nct_id>NCT06025253</nct_id>
    </id_info>
    <brief_title>PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations</brief_title>
    <acronym>PINTA</acronym>
    <official_title>Prophylactic Single-Use Negative Pressure Wound Therapy Devices for Closed Incision Major Amputations</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>
        Many factors influence the risk wound complications. Notably, the presence of unreconstructed&#xD;
        proximal occlusive arterial disease is a major influence on stump healing. Patient factors&#xD;
        such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are&#xD;
        non-modifiable, particularly in the short-term setting. However, surgical factors may be&#xD;
        altered in an effort to reduce the risk of wound complications. One option amenable to&#xD;
        alteration is what dressing is applied to the closed incision upon procedure completion. The&#xD;
        type of dressing may influence factors such as bacterial access to the wound, the development&#xD;
        of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively,&#xD;
        these wound factors increase the risk of wound infection. Therefore, dressings which reduce&#xD;
        these factors have the potential to reduce wound breakdown, thereby reducing the burden for&#xD;
        patients and healthcare systems. Negative pressure wound therapy (NPWT) removes excess fluid&#xD;
        from wounds as well as limiting bacterial access. Negative pressure dressings consistent of&#xD;
        an open cell solid foam, placed on top of the incision and then covered with a semipermeable&#xD;
        membrane. A sealed tube connects the foam to a pump to create a partial vacuum over the&#xD;
        wound. This negative pressure leads to a sealed environment which prevents bacterial&#xD;
        migration into the wound while removing blood and serous exudate. Single-use NPWT systems&#xD;
        (such as Smith &amp; Nephew's PICOTM and Acelity's PrevenaTM) are now widely available. The&#xD;
        systems can be applied and left in place for up to seven days.&#xD;
  &#xD;
        Prophylactic NPWT in the setting of closed surgical incisions has been widely evaluated. The&#xD;
        most recent Cochrane review (2022) analysed data from 62 randomised controlled trials (RCTs)&#xD;
        and 6 economic studies (12). Data were reported from 13,340 participants, undergoing a wide&#xD;
        range of procedures (gastrointestinal, gynaecological, vascular, orthopaedic and&#xD;
        cardiothoracic). The review was concluded with moderate certainty that prophylactic NPWT&#xD;
        reduces SSI but not wound dehiscence. There was a possibility that prophylactic NPWT reduces&#xD;
        mortality although the confidence intervals include the possibility of harm. Cost&#xD;
        effectiveness studies produced differing results in differing settings with no high-grade&#xD;
        evidence of cost efficacy. However, studies specifically investigating the impact of NPWT on&#xD;
        closed incision major LEAs are scarce. Early results from a pilot study of prospective,&#xD;
        multi-centre, two-arm, randomized controlled trial comparing NPWT to standard dressings after&#xD;
        above knee amputations (AKA) and below-knee amputations (BKA) reported promising results&#xD;
        (13). In this initial review of 43 patients, NPWT reduced the wound complication rates at 30&#xD;
        days, with complications noted in 5 of 21 controls (23.8%) and 1 of 22 (4.5%) in the&#xD;
        treatment group (p=0.068). Despite this, the absence of robust cost effectiveness data to&#xD;
        support the routine use of NPWT is of concern. NPWT is considerably more expensive than&#xD;
        traditional dressings (approximately £120-145 versus £4 for a standard dressing). In&#xD;
        addition, the Cochrane reviewers noted that pain and health-related quality of life were not&#xD;
        reported by most of their included RCTs (12). Most studies randomised patients at high-risk&#xD;
        for wound complications but did not always define high-risk clearly. Finally, the definition&#xD;
        of surgical site infection varied amongst included studies. In particular, it remains unclear&#xD;
        whether NPWT reduces all wound infections, superficial infections alone or deep infections.&#xD;
  &#xD;
        Negative-pressure wound dressings rely on a robust seal around the wound to function. This&#xD;
        can be difficult to achieve on the relatively irregular shape of a major limb amputation&#xD;
        wound. Seal failures often result in dressings changes, substantially increasing associated&#xD;
        costs. Prospective evaluation of wound complications in a trial setting utilising&#xD;
        standardised criteria will generate a robust baseline rate upon which to generate a sample&#xD;
        size calculation for a full trial.&#xD;
  &#xD;
        We propose to conduct a multicentre randomised controlled trial comparing prophylactic&#xD;
        single-use negative pressure wound therapy with standard dressings in patients with in&#xD;
        patients with a closed incision following major lower extremity amputation in terms of SSI&#xD;
        incidence, wound healing complications and scar appearance, patient quality of life and&#xD;
        financial impact on the patient and healthcare system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">March 1, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Any wound complication of the amputation stump, including wound infection, dehiscence, seroma, haematoma and stump necrosis.</measure>
      <time_frame>1 month post surgery</time_frame>
      <description>The Centre for Disease Control and Prevention definitions of surgical site infection will be used.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of days to discharge</measure>
      <time_frame>6 months</time_frame>
      <description>The length of time the patient is in hospital from date of surgery to date of discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Re-operations</measure>
      <time_frame>1 Month</time_frame>
      <description>Any re-operations undertaken</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">728</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>Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Wound dressing</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Application of sterile standard gauze dressing to the wound post major lower extremity amputation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Negative Pressure Wound Therapy</intervention_name>
      <description>Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation</description>
      <arm_group_label>Negative Pressure Wound Therapy.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard Wound Dressing</intervention_name>
      <description>Application of standard wound dressing post major lower extremity amputation</description>
      <arm_group_label>Standard Wound dressing</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          i) They are aged 18 years or older; ii) Undergoing major lower extremity amputation,&#xD;
          including below-knee amputation, through-knee amputation and above-knee amputation, for any&#xD;
          indication; iii) With primary closure of the surgical incision using either interrupted or&#xD;
          continuous sutures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          i) Patients &lt;18 years; ii) Women who are pregnant and/or breast-feeding; iii) Amputations&#xD;
          performed without primary skin closure, including guillotine amputations, amputations&#xD;
          deliberately left open for drainage purposes and amputations with soft tissues defects at&#xD;
          the stump; iv) Amputations with skin glue as the only means of skin closure v) Clinically&#xD;
          absent femoral pulse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Post-operative Complications</keyword>
    <keyword>Abdominal Incision</keyword>
    <keyword>Health Economics</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/NCT06025253
  org study id: RCSI-PINTA
  nct id: NCT06025253
  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.
  Many factors influence the risk wound complications. Notably, the presence of unreconstructed
        proximal occlusive arterial disease is a major influence on stump healing. Patient factors
        such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are
        non-modifiable, particularly in the short-term setting. However, surgical factors may be
        altered in an effort to reduce the risk of wound complications. One option amenable to
        alteration is what dressing is applied to the closed incision upon procedure completion. The
        type of dressing may influence factors such as bacterial access to the wound, the development
        of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively,
        these wound factors increase the risk of wound infection. Therefore, dressings which reduce
        these factors have the potential to reduce wound breakdown, thereby reducing the burden for
        patients and healthcare systems. Negative pressure wound therapy (NPWT) removes excess fluid
        from wounds as well as limiting bacterial access. Negative pressure dressings consistent of
        an open cell solid foam, placed on top of the incision and then covered with a semipermeable
        membrane. A sealed tube connects the foam to a pump to create a partial vacuum over the
        wound. This negative pressure leads to a sealed environment which prevents bacterial
        migration into the wound while removing blood and serous exudate. Single-use NPWT systems
        (such as Smith & Nephew's PICOTM and Acelity's PrevenaTM) are now widely available. The
        systems can be applied and left in place for up to seven days.
  
        Prophylactic NPWT in the setting of closed surgical incisions has been widely evaluated. The
        most recent Cochrane review (2022) analysed data from 62 randomised controlled trials (RCTs)
        and 6 economic studies (12). Data were reported from 13,340 participants, undergoing a wide
        range of procedures (gastrointestinal, gynaecological, vascular, orthopaedic and
        cardiothoracic). The review was concluded with moderate certainty that prophylactic NPWT
        reduces SSI but not wound dehiscence. There was a possibility that prophylactic NPWT reduces
        mortality although the confidence intervals include the possibility of harm. Cost
        effectiveness studies produced differing results in differing settings with no high-grade
        evidence of cost efficacy. However, studies specifically investigating the impact of NPWT on
        closed incision major LEAs are scarce. Early results from a pilot study of prospective,
        multi-centre, two-arm, randomized controlled trial comparing NPWT to standard dressings after
        above knee amputations (AKA) and below-knee amputations (BKA) reported promising results
        (13). In this initial review of 43 patients, NPWT reduced the wound complication rates at 30
        days, with complications noted in 5 of 21 controls (23.8%) and 1 of 22 (4.5%) in the
        treatment group (p=0.068). Despite this, the absence of robust cost effectiveness data to
        support the routine use of NPWT is of concern. NPWT is considerably more expensive than
        traditional dressings (approximately £120-145 versus £4 for a standard dressing). In
        addition, the Cochrane reviewers noted that pain and health-related quality of life were not
        reported by most of their included RCTs (12). Most studies randomised patients at high-risk
        for wound complications but did not always define high-risk clearly. Finally, the definition
        of surgical site infection varied amongst included studies. In particular, it remains unclear
        whether NPWT reduces all wound infections, superficial infections alone or deep infections.
  
        Negative-pressure wound dressings rely on a robust seal around the wound to function. This
        can be difficult to achieve on the relatively irregular shape of a major limb amputation
        wound. Seal failures often result in dressings changes, substantially increasing associated
        costs. Prospective evaluation of wound complications in a trial setting utilising
        standardised criteria will generate a robust baseline rate upon which to generate a sample
        size calculation for a full trial.
  
        We propose to conduct a multicentre randomised controlled trial comparing prophylactic
        single-use negative pressure wound therapy with standard dressings in patients with in
        patients with a closed incision following major lower extremity amputation in terms of SSI
        incidence, wound healing complications and scar appearance, patient quality of life and
        financial impact on the patient and healthcare system.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Any wound complication of the amputation stump, including wound infection, dehiscence, seroma, haematoma and stump necrosis.
  time frame: 1 month post surgery
  description: The Centre for Disease Control and Prevention definitions of surgical site infection will be used.
  measure: Number of days to discharge
  time frame: 6 months
  description: The length of time the patient is in hospital from date of surgery to date of discharge
  measure: Re-operations
  time frame: 1 Month
  description: Any re-operations undertaken
  arm group label: Negative Pressure Wound Therapy.
  arm group type: Experimental
  description: Application of a negative wound pressure therapy dressing to the wound post major lower extremity amputation
  arm group label: Standard Wound dressing
  arm group type: Active Comparator
  description: Application of sterile standard gauze dressing to the wound post major lower extremity amputation
  intervention type: Device
  intervention name: Negative Pressure Wound Therapy
  description: Application of negative-pressure wound therapy (NPWT) post major lower extremity amputation
  arm group label: Negative Pressure Wound Therapy.
  intervention type: Device
  intervention name: Standard Wound Dressing
  description: Application of standard wound dressing post major lower extremity amputation
  arm group label: Standard Wound dressing
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Wound Infection
  mesh term: Wounds and Injuries
  mesh term: Surgical Wound
  sharing ipd: No