<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/NCT03820648</url>
  </required_header>
  <id_info>
    <org_study_id>CE 1369 cesc</org_study_id>
    <nct_id>NCT03820648</nct_id>
  </id_info>
  <brief_title>Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy</brief_title>
  <acronym>PALEXIS</acronym>
  <official_title>Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy: a Randomized Single-blind Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Universitaria Integrata Verona</source>
  <oversight_info>
    <has_dmc>No</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>
      Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in&#xD;
      North America and worldwide. This condition has consistently been reported to account for up&#xD;
      to 25% of all healthcare-associated infections. In a cost analysis, SSIs&#xD;
      post-pancreaticoduodenectomy (PD) dramatically increases the treatment costs. More&#xD;
      importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which&#xD;
      is indicated in the majority of patients undergoing PD for pancreatic cancer. Protective&#xD;
      covers or 'wound protectors' are hypothesized to be an improvement over adhesive membrane&#xD;
      barriers as they are believed to reduce intraoperative contamination while concomitantly&#xD;
      preserving the temperature and humidity of the surgical wound. The aim of this study is to&#xD;
      assess if the use of wound protector can reduce the wound infection rate in patients&#xD;
      undergoing to PD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in&#xD;
      North America and worldwide. This condition has consistently been reported to account for up&#xD;
      to 25% of all healthcare-associated infections. Prolonged hospitalization, more frequent&#xD;
      hospital re-admissions after surgery and a greater than twofold increase in costs and&#xD;
      mortality have consistently been associated with this condition over the past decade. The SSI&#xD;
      is associated with an increased risk of postsurgical pain, poor wound healing and aesthetic&#xD;
      results and an increased risk of incisional hernias. The literature shows an incidence rate&#xD;
      of SSI at 30 days after surgery that reaches 51% of cases. In particular, the incidence of&#xD;
      wound infection is 15%. In our experience, the rate of wound infection in patients undergoing&#xD;
      Pancreaticoduodenectomy (PD) is 10%.&#xD;
&#xD;
      SSI is an infectious process that is localized to surgical incision level and it is&#xD;
      classified as being either incisional or organ/space. Incisional SSI is further divided into&#xD;
      those involving only skin and subcutaneous tissue (superficial incisional SSI) and those&#xD;
      involving deeper soft tissues of the incision (deep incisional SSI).&#xD;
&#xD;
      In a cost analysis, SSIs post-PD dramatically increases the treatment costs. More&#xD;
      importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which&#xD;
      is indicated in the majority of patients undergoing PD for pancreatic cancer. During recent&#xD;
      years there is also an increasing incidence of antibiotic-resistant pathogens in hospitals,&#xD;
      so several studies have suggested primary or secondary prevention strategies to reduce SSI&#xD;
      rate. In order to minimize the risk of SSI, various measures of perioperative care have&#xD;
      already been adopted, including the cleaning of the skin, the hair removal of the&#xD;
      intervention area, the prevention of intraoperative hypothermia and perioperative antibiotic&#xD;
      therapy. However there are few studies on the effectiveness of surgical procedures for&#xD;
      primary prevention to reduce the contamination in the surgical site, especially in patients&#xD;
      undergoing major gastrointestinal surgery. The surgical procedures classified as contaminated&#xD;
      or dirty (with a higher bacterial load within the surgical site and/or regarding&#xD;
      gastrointestinal or biliary tracts) remain associated with an increased risk of SSI, about&#xD;
      two times, compared to the interventions classified as clean or clean-contaminated. The PD is&#xD;
      classified as surgery contaminated / dirty.&#xD;
&#xD;
      The use of adhesive membrane barriers over the skin of the surgical site emerged 50 years ago&#xD;
      as a possible solution to minimize endogenous cross-contamination during surgery. The initial&#xD;
      idea relied on the principle of reducing exposure of the surgical site to bacteria inherent&#xD;
      in the surrounding skin or to airborne bacteria in the operating room. Major applicability&#xD;
      was expected in clean surgeries, where the skin is considered the main source of bacteria.&#xD;
      Unfortunately, however, no evidence in support of plastic adhesive drapes was found in a&#xD;
      recently updated systematic review of randomized controlled trials (RCTs) including five&#xD;
      studies and 3082 patients. In fact, a 23% increase in the risk of SSI was found in the group&#xD;
      that received adhesive drapes. In the 1960s, other devices were described and then developed&#xD;
      based on the concept of combining a non-traumatic surgical wound retractor with a protective&#xD;
      membrane covering of the incisional margin in abdominal surgeries. Such protective covers or&#xD;
      'wound protectors' (WP) were hypothesized to be an improvement over adhesive membrane&#xD;
      barriers as they were believed to reduce intraoperative contamination while concomitantly&#xD;
      preserving the temperature and humidity of the surgical wound. In support of this hypothesis,&#xD;
      early studies demonstrated reduced exposure of the surgical wound to enteric bacteria at the&#xD;
      end of gastrointestinal operations. These results were further supported by several RCTs,&#xD;
      which demonstrated that wound protectors were efficacious in reducing the incidence of&#xD;
      incisional SSI as compared to usual care in patients undergoing gastrointestinal surgeries. A&#xD;
      recently meta-analysis of RCTs on the WP enrolled 6 studies and 1008 patients, finding that&#xD;
      the pooled estimated risk of SSI among patients fitted with wound protectors during surgery&#xD;
      was 0.55 (95% CI 0.31 to 0.98) times the pooled estimated risk of SSI in control groups.&#xD;
&#xD;
      The aim of this study is to assess if the use of WP can reduce the wound infection rate in&#xD;
      patients undergoing to PD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no differences between the groups at the interim analysis&#xD;
  </why_stopped>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">December 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 9, 2019</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>The study is an RCT, single-blinded, conducts in patients with cancer submitted to PD (1:1). In the experimental group, we will use the dual-ring WP Alexis (Applied Medical, Rancho Santa Margarita, California, USA), while in the control group we will use the standard 3M™ Steri-Drape 2. There is planned a clinical visit of follow-up on the 30th day from the operation day (as in clinical practice).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>30th day postoperative</time_frame>
    <description>Number of SSI onset in patients submitted to PD until the 30th day postoperative. This endpoint will be compared between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device resistance</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Number intraoperative device rupture in both groups. It will be also recorded the number of device lesions seen at the end of the surgical operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment costs related to increased hospital stays due to SSI</measure>
    <time_frame>30th day postoperative</time_frame>
    <description>Number of additional days to the average hospital stays (7 days) of the patients submitted to PD at our Institute, related to the onset of SSI until the 30th day postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs related to the use of additional antibiotics administered for the treatment of SSI</measure>
    <time_frame>30th day postoperative</time_frame>
    <description>Evaluation of the total costs of the additional antibiotic therapy administered for the treatment of SSI, developed within the 30th day postoperative, in the two patient groups. It will be considered like the ex-factory price of the drug.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">212</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Alexis® device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, we will be used WP dual-ring Alexis® (Figure 1). The Alexis® 's size will be decided on the basis of abdominal incision (Alexis® X-Large or Alexis® XX-Large will be used for 11-17cm or 17-25 cm incision length respectively)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard 3M™ Steri-Drape 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, we will be used Standard 3M™ Steri-Drape 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alexis</intervention_name>
    <description>The Alexis® (Applied Medical) is a surgical device indicated for use in retracting and protecting an incision during laparoscopic or open surgery. It is intended to allow the surgeon to access through an atraumatic circumferentially 360 degrees retracted wound that provides maximum exposure with minimum incision size. Further, once positioned, the Alexis Wound Retractor is intended to protect against wound contamination.The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part 1: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.</description>
    <arm_group_label>Alexis® device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard 3M™ Steri-Drape 2</intervention_name>
    <description>Standard 3M™ Steri-Drape 2 is a standard drape applicated on the skin of the patient before the surgical incision.</description>
    <arm_group_label>Standard 3M™ Steri-Drape 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for elective PD&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Ability of the subject to understand character and individual consequences of the&#xD;
             clinical trial&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Unable to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AOUI Verona</name>
      <address>
        <city>Verona</city>
        <zip>37124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>September 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</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/NCT03820648
org study id: CE 1369 cesc
nct id: NCT03820648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in
      North America and worldwide. This condition has consistently been reported to account for up
      to 25% of all healthcare-associated infections. In a cost analysis, SSIs
      post-pancreaticoduodenectomy (PD) dramatically increases the treatment costs. More
      importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which
      is indicated in the majority of patients undergoing PD for pancreatic cancer. Protective
      covers or 'wound protectors' are hypothesized to be an improvement over adhesive membrane
      barriers as they are believed to reduce intraoperative contamination while concomitantly
      preserving the temperature and humidity of the surgical wound. The aim of this study is to
      assess if the use of wound protector can reduce the wound infection rate in patients
      undergoing to PD.
Surgical site infection (SSI) is a leading cause of preventable morbidity and mortality in
      North America and worldwide. This condition has consistently been reported to account for up
      to 25% of all healthcare-associated infections. Prolonged hospitalization, more frequent
      hospital re-admissions after surgery and a greater than twofold increase in costs and
      mortality have consistently been associated with this condition over the past decade. The SSI
      is associated with an increased risk of postsurgical pain, poor wound healing and aesthetic
      results and an increased risk of incisional hernias. The literature shows an incidence rate
      of SSI at 30 days after surgery that reaches 51% of cases. In particular, the incidence of
      wound infection is 15%. In our experience, the rate of wound infection in patients undergoing
      Pancreaticoduodenectomy (PD) is 10%.

      SSI is an infectious process that is localized to surgical incision level and it is
      classified as being either incisional or organ/space. Incisional SSI is further divided into
      those involving only skin and subcutaneous tissue (superficial incisional SSI) and those
      involving deeper soft tissues of the incision (deep incisional SSI).

      In a cost analysis, SSIs post-PD dramatically increases the treatment costs. More
      importantly, postoperative wound infections delay postoperative adjuvant chemotherapy, which
      is indicated in the majority of patients undergoing PD for pancreatic cancer. During recent
      years there is also an increasing incidence of antibiotic-resistant pathogens in hospitals,
      so several studies have suggested primary or secondary prevention strategies to reduce SSI
      rate. In order to minimize the risk of SSI, various measures of perioperative care have
      already been adopted, including the cleaning of the skin, the hair removal of the
      intervention area, the prevention of intraoperative hypothermia and perioperative antibiotic
      therapy. However there are few studies on the effectiveness of surgical procedures for
      primary prevention to reduce the contamination in the surgical site, especially in patients
      undergoing major gastrointestinal surgery. The surgical procedures classified as contaminated
      or dirty (with a higher bacterial load within the surgical site and/or regarding
      gastrointestinal or biliary tracts) remain associated with an increased risk of SSI, about
      two times, compared to the interventions classified as clean or clean-contaminated. The PD is
      classified as surgery contaminated / dirty.

      The use of adhesive membrane barriers over the skin of the surgical site emerged 50 years ago
      as a possible solution to minimize endogenous cross-contamination during surgery. The initial
      idea relied on the principle of reducing exposure of the surgical site to bacteria inherent
      in the surrounding skin or to airborne bacteria in the operating room. Major applicability
      was expected in clean surgeries, where the skin is considered the main source of bacteria.
      Unfortunately, however, no evidence in support of plastic adhesive drapes was found in a
      recently updated systematic review of randomized controlled trials (RCTs) including five
      studies and 3082 patients. In fact, a 23% increase in the risk of SSI was found in the group
      that received adhesive drapes. In the 1960s, other devices were described and then developed
      based on the concept of combining a non-traumatic surgical wound retractor with a protective
      membrane covering of the incisional margin in abdominal surgeries. Such protective covers or
      'wound protectors' (WP) were hypothesized to be an improvement over adhesive membrane
      barriers as they were believed to reduce intraoperative contamination while concomitantly
      preserving the temperature and humidity of the surgical wound. In support of this hypothesis,
      early studies demonstrated reduced exposure of the surgical wound to enteric bacteria at the
      end of gastrointestinal operations. These results were further supported by several RCTs,
      which demonstrated that wound protectors were efficacious in reducing the incidence of
      incisional SSI as compared to usual care in patients undergoing gastrointestinal surgeries. A
      recently meta-analysis of RCTs on the WP enrolled 6 studies and 1008 patients, finding that
      the pooled estimated risk of SSI among patients fitted with wound protectors during surgery
      was 0.55 (95% CI 0.31 to 0.98) times the pooled estimated risk of SSI in control groups.

      The aim of this study is to assess if the use of WP can reduce the wound infection rate in
      patients undergoing to PD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is an RCT, single-blinded, conducts in patients with cancer submitted to PD (1:1). In the experimental group, we will use the dual-ring WP Alexis (Applied Medical, Rancho Santa Margarita, California, USA), while in the control group we will use the standard 3M™ Steri-Drape 2. There is planned a clinical visit of follow-up on the 30th day from the operation day (as in clinical practice).
primary purpose: Treatment
masking: Single (Participant)
measure: Surgical site infection
time frame: 30th day postoperative
description: Number of SSI onset in patients submitted to PD until the 30th day postoperative. This endpoint will be compared between the two groups.
measure: Device resistance
time frame: Intraoperative
description: Number intraoperative device rupture in both groups. It will be also recorded the number of device lesions seen at the end of the surgical operation.
measure: Treatment costs related to increased hospital stays due to SSI
time frame: 30th day postoperative
description: Number of additional days to the average hospital stays (7 days) of the patients submitted to PD at our Institute, related to the onset of SSI until the 30th day postoperative
measure: Costs related to the use of additional antibiotics administered for the treatment of SSI
time frame: 30th day postoperative
description: Evaluation of the total costs of the additional antibiotic therapy administered for the treatment of SSI, developed within the 30th day postoperative, in the two patient groups. It will be considered like the ex-factory price of the drug.
arm group label: Alexis® device
arm group type: Experimental
description: In this group, we will be used WP dual-ring Alexis® (Figure 1). The Alexis® 's size will be decided on the basis of abdominal incision (Alexis® X-Large or Alexis® XX-Large will be used for 11-17cm or 17-25 cm incision length respectively)
arm group label: Standard 3M™ Steri-Drape 2
arm group type: Active Comparator
description: In this group, we will be used Standard 3M™ Steri-Drape 2
intervention type: Device
intervention name: Alexis
description: The Alexis® (Applied Medical) is a surgical device indicated for use in retracting and protecting an incision during laparoscopic or open surgery. It is intended to allow the surgeon to access through an atraumatic circumferentially 360 degrees retracted wound that provides maximum exposure with minimum incision size. Further, once positioned, the Alexis Wound Retractor is intended to protect against wound contamination.The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part 1: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.
arm group label: Alexis® device
intervention type: Device
intervention name: Standard 3M™ Steri-Drape 2
description: Standard 3M™ Steri-Drape 2 is a standard drape applicated on the skin of the patient before the surgical incision.
arm group label: Standard 3M™ Steri-Drape 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Surgical Wound Infection
sharing ipd: No