<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/NCT03820219</url>
  </required_header>
  <id_info>
    <org_study_id>REB1023961</org_study_id>
    <nct_id>NCT03820219</nct_id>
  </id_info>
  <brief_title>Incisional Negative Pressure Wound Therapy in Patients Undergoing Spine Surgery</brief_title>
  <official_title>A Pilot Study Comparing Incisional Negative Pressure Wound Therapy (Prevena) to Conventional Sterile Dressing in Patients Undergoing Thoracolumbar Posterior Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</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>
      Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are&#xD;
      known to have higher rates of wound complications relative to other areas of the body.&#xD;
      Instrumentation, repeat surgery and prior radiation all contribute to more hostile&#xD;
      environments for wound healing. The purpose of this study is to determine whether incisional&#xD;
      vacuum dressings can help improve the healing/complication rates associated with these&#xD;
      wounds.&#xD;
&#xD;
      Methods: Patients will be recruited over a two year span as part of the initial pilot study&#xD;
      to determine the capabilities/practicality of recruitment locally. Patients will be followed&#xD;
      in and out of hospital for 3 months or until the wound has healed clinically. The primary&#xD;
      outcome, surgical site infection (SSI), will be evaluated using prior Centre for Disease&#xD;
      Control (CDC) definitions. STATA will be used for statistical analysis.&#xD;
&#xD;
      Anticipated results: Although the incisional vacuum system (PrevenaTM) has been used&#xD;
      previously for spine wounds, there are no randomized control trials compared with standard&#xD;
      dressings. Since the infection rate in these wounds has been founds previously to be quite&#xD;
      high (10-25%) a reduction could have profound significant benefits on patient morbidity and&#xD;
      overall costs to the healthcare system. The pilot study will help inform the direction of a&#xD;
      larger, potentially multi-centered trial.&#xD;
&#xD;
      Conclusion: If a large treatment effect is demonstrated with the PrevenaTM System then this&#xD;
      could potentially change the standard of care for complex spine wounds.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with surgical site infection (SSI) of the spine have higher morbidity and mortality&#xD;
      and higher costs of care. Hospital length of stay has been shown to be significantly longer,&#xD;
      and readmission rate significantly higher, for infected patients than that for uninfected&#xD;
      patients. Repeated surgery, typically irrigation and debridement (I&amp;D), due to deep SSI is&#xD;
      required in the majority of these patients. The risk of post-operative spinal wound infection&#xD;
      is reported to be 1-20% depending on patient factors, surgical factors and spine pathology&#xD;
      factors. The risk of SSI can be as high as 10-25% in major risk groups, such as posterior&#xD;
      surgical approach in revision lumbar surgery, thoracolumbar trauma with neurological deficit,&#xD;
      and in surgery for metastatic disease. Wound complications such as seroma or dehiscence can&#xD;
      be as high as 40% in spine oncology patients, especially if they have received radiation&#xD;
      and/or chemotherapy. Definitive management is based on etiology, clinical course, and patient&#xD;
      risk factors. A patient who develops a post-operative wound infection often requires&#xD;
      prolonged hospitalization, revision surgical procedures, and long-term intravenous&#xD;
      antibiotics, which significantly increase health care resource utilization, and thus the&#xD;
      overall cost. Awareness of risk factors and development of preventive measures can lead to&#xD;
      improved outcomes.&#xD;
&#xD;
      There are many supplemental treatment strategies for post-operative spine infection and wound&#xD;
      complications in addition to I&amp;D. Vacuum assisted closure (VAC) of infected spine wounds has&#xD;
      proven to be an acceptable adjunct to aid in the closure or staging of complex spinal wounds.&#xD;
      The VAC system has proven to be safe and effective in the treatment of complex spinal wounds,&#xD;
      spinal SSI and wounds that are at high risk for failed primary closure. Indications for VAC&#xD;
      treatment as a means of preventing wound complications are evolving. Preemptive use of VAC&#xD;
      treatment on closed primary wounds has been employed in high risk (morbidly obese) patients&#xD;
      with acetabular fractures, and successful outcomes have been achieved. Use of VAC treatment&#xD;
      on closed wounds as a preventive measure in properly selected patients appears safe and has&#xD;
      effectively decreased wound complication rates. This mode of prophylactic treatment is called&#xD;
      &quot;incisional VAC therapy&quot;.&#xD;
&#xD;
      KCI (the manufacturer of a Vacuum Assisted Closure System) has gained FDA and Health Canada&#xD;
      approval for a specific device called &quot;Prevena™&quot;, which is designed for incisional vacuum&#xD;
      therapy. The Prevena™ System is indicated for use over clean, closed incisions that continue&#xD;
      to drain following sutured or stapled closure. It acts by removing exudate, helping hold the&#xD;
      edges of the incision together and protecting the surgical site from external contamination&#xD;
      in a clean, protected postoperative wound environment.&#xD;
&#xD;
      To date, no studies have been done to establish the efficacy of the Prevena™ System for use&#xD;
      on patients requiring spine surgery to reduce wound complications such as SSI, wound&#xD;
      dehiscence, or seroma formation. A recent systematic review of published studies examining&#xD;
      the use of dressings and drains in posterior spinal surgery found no evidence to support the&#xD;
      use of any particular system. A number of recent studies have also examined the incidence of&#xD;
      surgical site infection in different high-risk populations (10-25%) and a predictive model&#xD;
      for the development of a complex post surgical wound infection. The factors identified lead&#xD;
      to considerable disability, cost and additional utilization of health care resources. If a&#xD;
      prophylactic wound treatment can decrease wound complications in high risk patients, this may&#xD;
      lead to a decreased need for post-operative services, reduced complication rate, less&#xD;
      antibiotic usage and fewer returns to the operating room. If patients can avoid&#xD;
      complications, they can resume normal activities faster and ultimately should have higher&#xD;
      satisfaction.&#xD;
&#xD;
      In an era where health expenditure is literally exploding and becoming non-sustainable in&#xD;
      many countries, cost effectiveness analysis is required to responsibly manage scarce health&#xD;
      care resources. Specifically in the context of SSI, is the added cost of the Prevena™ System&#xD;
      justified by the potential decrease in wound complication rate?&#xD;
&#xD;
      HYPOTHESIS:&#xD;
&#xD;
      Use of the Prevena™ System will decrease the rate of acute post-operative Surgical Site&#xD;
      Infection.&#xD;
&#xD;
      STUDY DESIGN:&#xD;
&#xD;
      Consenting patients will be randomized to receive either standard sterile wound dressing or&#xD;
      the Prevena™ System at the time of closure of the surgical wound. Consenting and&#xD;
      randomization will be performed by a member of the research team. Post-stratification&#xD;
      randomization will be performed based on the three clinical presentation groups (revision&#xD;
      surgery, metastatic tumor and trauma with deficit). This ensures that the investigators get&#xD;
      appropriate randomization within each of the three clinical groups.&#xD;
&#xD;
      DATA COLLECTION:&#xD;
&#xD;
      The following data elements (with their time of collection) will be collected from the&#xD;
      patient's hospital chart of during follow-up clinical assessment&#xD;
&#xD;
      Patient Factors:&#xD;
&#xD;
      Gender (Consent) Age (Consent) Diabetes (Admission) BMI (Admission) Previous radiation to&#xD;
      planned surgical site (Admission) Currently undergoing chemotherapy (Admission) Smoker&#xD;
      (Admission)&#xD;
&#xD;
      Surgical Factors:&#xD;
&#xD;
      Date of Surgery (Surgery) Surgical Skin Preparation (Surgery) Estimated blood loss (Surgery)&#xD;
      Incision size (Surgery) Drains (Surgery) Instrumentation (Surgery) Number of levels in&#xD;
      decompression/fusion (Surgery) Blood transfusion (Surgery) Type of incision closure -&#xD;
      staples/suture (Surgery) Procedure details - Spine Surgical Invasiveness Index (Surgery)&#xD;
&#xD;
      Hospital Stay:&#xD;
&#xD;
      Admission Date (Admission) Discharge Date (Discharge) ICU admission pre-op (Admission) ICU&#xD;
      admission post-op (Admission) Antibiotic Use (Discharge)&#xD;
&#xD;
      Wound:&#xD;
&#xD;
      Exudate (Follow-up) Erythema (Follow-up) Separation of deep tissues (Follow-up)&#xD;
&#xD;
      Dressing Factors:&#xD;
&#xD;
      Dressing Supply Utilization (Discharge)&#xD;
&#xD;
      Data for each patient will be collected using the patient's hospital chart and visual&#xD;
      inspection of the wound by a clinician. One questionnaire, the EQ5D, will be completed by&#xD;
      study participants, with the help of a research assistant at Baseline (after obtaining&#xD;
      consent), on Post-operative Day 7, Day 14 and Week 6. Participants will also be asked to&#xD;
      complete this questionnaire if they have any unscheduled/unplanned encounters related to the&#xD;
      occurrence of either a primary (SSI) or secondary (dehiscence/seroma) outcome during the&#xD;
      study period.&#xD;
&#xD;
      METHODOLOGY:&#xD;
&#xD;
      Elective patients (revision and some metastatic cases) will be introduced to the study at the&#xD;
      time of surgical consent by a member of the research team. Emergent patients (all trauma and&#xD;
      most metastatic cases) will be introduced to the study pre-operatively in the Emergency&#xD;
      Department or in the Orthopaedic Clinic by a member of the research team. Study participants&#xD;
      will be randomized prior to surgery to receive either the Prevena™ System or standard wound&#xD;
      care.&#xD;
&#xD;
      All consenting participants will be randomized, based on the three primary diagnostic groups&#xD;
      (revision surgery, metastatic disease or fracture with deficit). Study participants who&#xD;
      receive the 'standard wound care' will have the dressing changed 3 days after their surgery&#xD;
      and will have study encounters on Post-operative Day 7, Day 14 and Week 6 for wound&#xD;
      inspection, dressing change (Day 7) and suture/staple removal (Day 14). Study participants&#xD;
      who receive the Prevena™ System will have the same schedule of study encounters for wound&#xD;
      inspection (Post-operative Day 7, Day 14 and Week 6). The Prevena™ System will be removed on&#xD;
      Day 7 and a dry, sterile dressing will be applied. On Day 14 sutures/staples will be removed.&#xD;
&#xD;
      Patients who have not yet been discharged at the time of the scheduled study encounter will&#xD;
      be seen in hospital. Patients who have been discharged prior to any scheduled study&#xD;
      encounters will be seen in a follow-up spine clinic.&#xD;
&#xD;
      Participants will all be assigned a unique study ID and the treatment allocation will be&#xD;
      hidden for the purposes of analysis. It will be impossible to blind physicians or&#xD;
      participants to the treatment group given the obvious difference in appearance of the&#xD;
      Prevena™ System versus standard wound dressing.&#xD;
&#xD;
      STATISTICS:&#xD;
&#xD;
      A power calculation has been performed to determine the number of participants required. This&#xD;
      analysis has presumed an incidence of SSI of 15% (based on an averaging calculation of&#xD;
      published data for these high risk groups), and used a 2-tailed analysis, assuming a power of&#xD;
      0.8 and a Type I error of 5%. For a 50% decrease in primary outcome rates, Surgical Site&#xD;
      Infection, (15% to 7.5%), 275 participants per group will be required. The pilot data&#xD;
      generated from the proposed study will allow for refinement of this target recruitment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2019</start_date>
  <completion_date type="Actual">December 12, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>Consenting patients will be randomized to receive either standard sterile wound dressing or the Prevena™ System at the time of closure of the surgical wound.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The treatment allocation will be hidden for the purposes of analysis. It will be impossible to blind physicians or participants to the treatment group given the obvious difference in appearance of the Prevena™ System versus standard wound dressing.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of acute post-operative Surgical Site Infection (SSI)</measure>
    <time_frame>6 weeks</time_frame>
    <description>The incidence rate of SSI for patients with the Prevena™ System will be compared to those with the standard dressing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post operative wound seroma or dehiscence</measure>
    <time_frame>1 week</time_frame>
    <description>The incidence of wounds requiring aspiration, surgical exploration, or incision repair for patients with the Prevena™ System will be compared to those with the standard dressing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource time commitment</measure>
    <time_frame>2 weeks</time_frame>
    <description>The time and resource commitment for post-operative, in-hospital, wound management for patients with the Prevena™ System will be compared to those with the standard dressing. This data is collected on a standardized log sheet appended to the nursing folio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return visits</measure>
    <time_frame>6 weeks</time_frame>
    <description>The number of unanticipated post-op clinic visits, hospital readmissions and, emergency department/urgent-unplanned clinic evaluations for patients with the Prevena™ System will be compared to those with the standard dressing.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Standard sterile wound dressing</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prevena™ system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment, until it is removed at Post-Operative Day 7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prevena™ system</intervention_name>
    <description>The Prevena™ System acts by removing exudate from a clean, closed incision. It helps hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.</description>
    <arm_group_label>Prevena™ system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard sterile wound dressing</intervention_name>
    <description>Standard wound care involves the application of an occlusive dressing in the operating room.</description>
    <arm_group_label>Standard sterile wound dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of and agree to consent to randomization&#xD;
&#xD;
          -  Require spine surgery with a posterior midline incision that involves the thoracic,&#xD;
             lumbar and/or sacral spine&#xD;
&#xD;
          -  Be one of the following clinical presentation groups:&#xD;
&#xD;
               1. Metastatic Tumor of the Thoracic or Lumbar spine (T1-S5), requiring&#xD;
                  instrumentation and decompression, with or without pre-operative site radiation&#xD;
&#xD;
               2. Revisions Surgery requiring additional instrumentation or revision&#xD;
                  instrumentation, for thoracolumbar degeneration or deformity (T1-S1), index&#xD;
                  surgery &gt;6 months prior&#xD;
&#xD;
               3. Acute Traumatic Thoracolumbar (T1-L5) fracture(s) with neurological deficit (AIS&#xD;
                  A-C), requiring instrumentation and decompression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Initially:&#xD;
&#xD;
          -  Undergoing percutaneous surgery&#xD;
&#xD;
          -  Active Surgical Site infection or Primary Spinal Column infection or Distant Site&#xD;
             Infection (urinary tract, respiratory tract, etc.)&#xD;
&#xD;
        Subsequently:&#xD;
&#xD;
          -  Failure to complete the 6-week clinical follow-up (Loss to Follow Up)&#xD;
&#xD;
          -  Second surgery, at the same anatomical site, required during study time period (six&#xD;
             weeks), for causes other than primary (SSI) or secondary (Dehiscence, Seroma) study&#xD;
             endpoints.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nova Scotia Health</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia (NS)</state>
        <zip>B3L 4P1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 25, 2019</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 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spine</keyword>
  <keyword>surgical dressing</keyword>
  <keyword>negative pressure therapy</keyword>
  <keyword>surgical infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</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/NCT03820219
org study id: REB1023961
nct id: NCT03820219
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: Posterior post-operative spine wounds involving surgery at multiple levels are
      known to have higher rates of wound complications relative to other areas of the body.
      Instrumentation, repeat surgery and prior radiation all contribute to more hostile
      environments for wound healing. The purpose of this study is to determine whether incisional
      vacuum dressings can help improve the healing/complication rates associated with these
      wounds.

      Methods: Patients will be recruited over a two year span as part of the initial pilot study
      to determine the capabilities/practicality of recruitment locally. Patients will be followed
      in and out of hospital for 3 months or until the wound has healed clinically. The primary
      outcome, surgical site infection (SSI), will be evaluated using prior Centre for Disease
      Control (CDC) definitions. STATA will be used for statistical analysis.

      Anticipated results: Although the incisional vacuum system (PrevenaTM) has been used
      previously for spine wounds, there are no randomized control trials compared with standard
      dressings. Since the infection rate in these wounds has been founds previously to be quite
      high (10-25%) a reduction could have profound significant benefits on patient morbidity and
      overall costs to the healthcare system. The pilot study will help inform the direction of a
      larger, potentially multi-centered trial.

      Conclusion: If a large treatment effect is demonstrated with the PrevenaTM System then this
      could potentially change the standard of care for complex spine wounds.
Patients with surgical site infection (SSI) of the spine have higher morbidity and mortality
      and higher costs of care. Hospital length of stay has been shown to be significantly longer,
      and readmission rate significantly higher, for infected patients than that for uninfected
      patients. Repeated surgery, typically irrigation and debridement (I&D), due to deep SSI is
      required in the majority of these patients. The risk of post-operative spinal wound infection
      is reported to be 1-20% depending on patient factors, surgical factors and spine pathology
      factors. The risk of SSI can be as high as 10-25% in major risk groups, such as posterior
      surgical approach in revision lumbar surgery, thoracolumbar trauma with neurological deficit,
      and in surgery for metastatic disease. Wound complications such as seroma or dehiscence can
      be as high as 40% in spine oncology patients, especially if they have received radiation
      and/or chemotherapy. Definitive management is based on etiology, clinical course, and patient
      risk factors. A patient who develops a post-operative wound infection often requires
      prolonged hospitalization, revision surgical procedures, and long-term intravenous
      antibiotics, which significantly increase health care resource utilization, and thus the
      overall cost. Awareness of risk factors and development of preventive measures can lead to
      improved outcomes.

      There are many supplemental treatment strategies for post-operative spine infection and wound
      complications in addition to I&D. Vacuum assisted closure (VAC) of infected spine wounds has
      proven to be an acceptable adjunct to aid in the closure or staging of complex spinal wounds.
      The VAC system has proven to be safe and effective in the treatment of complex spinal wounds,
      spinal SSI and wounds that are at high risk for failed primary closure. Indications for VAC
      treatment as a means of preventing wound complications are evolving. Preemptive use of VAC
      treatment on closed primary wounds has been employed in high risk (morbidly obese) patients
      with acetabular fractures, and successful outcomes have been achieved. Use of VAC treatment
      on closed wounds as a preventive measure in properly selected patients appears safe and has
      effectively decreased wound complication rates. This mode of prophylactic treatment is called
      "incisional VAC therapy".

      KCI (the manufacturer of a Vacuum Assisted Closure System) has gained FDA and Health Canada
      approval for a specific device called "Prevena™", which is designed for incisional vacuum
      therapy. The Prevena™ System is indicated for use over clean, closed incisions that continue
      to drain following sutured or stapled closure. It acts by removing exudate, helping hold the
      edges of the incision together and protecting the surgical site from external contamination
      in a clean, protected postoperative wound environment.

      To date, no studies have been done to establish the efficacy of the Prevena™ System for use
      on patients requiring spine surgery to reduce wound complications such as SSI, wound
      dehiscence, or seroma formation. A recent systematic review of published studies examining
      the use of dressings and drains in posterior spinal surgery found no evidence to support the
      use of any particular system. A number of recent studies have also examined the incidence of
      surgical site infection in different high-risk populations (10-25%) and a predictive model
      for the development of a complex post surgical wound infection. The factors identified lead
      to considerable disability, cost and additional utilization of health care resources. If a
      prophylactic wound treatment can decrease wound complications in high risk patients, this may
      lead to a decreased need for post-operative services, reduced complication rate, less
      antibiotic usage and fewer returns to the operating room. If patients can avoid
      complications, they can resume normal activities faster and ultimately should have higher
      satisfaction.

      In an era where health expenditure is literally exploding and becoming non-sustainable in
      many countries, cost effectiveness analysis is required to responsibly manage scarce health
      care resources. Specifically in the context of SSI, is the added cost of the Prevena™ System
      justified by the potential decrease in wound complication rate?

      HYPOTHESIS:

      Use of the Prevena™ System will decrease the rate of acute post-operative Surgical Site
      Infection.

      STUDY DESIGN:

      Consenting patients will be randomized to receive either standard sterile wound dressing or
      the Prevena™ System at the time of closure of the surgical wound. Consenting and
      randomization will be performed by a member of the research team. Post-stratification
      randomization will be performed based on the three clinical presentation groups (revision
      surgery, metastatic tumor and trauma with deficit). This ensures that the investigators get
      appropriate randomization within each of the three clinical groups.

      DATA COLLECTION:

      The following data elements (with their time of collection) will be collected from the
      patient's hospital chart of during follow-up clinical assessment

      Patient Factors:

      Gender (Consent) Age (Consent) Diabetes (Admission) BMI (Admission) Previous radiation to
      planned surgical site (Admission) Currently undergoing chemotherapy (Admission) Smoker
      (Admission)

      Surgical Factors:

      Date of Surgery (Surgery) Surgical Skin Preparation (Surgery) Estimated blood loss (Surgery)
      Incision size (Surgery) Drains (Surgery) Instrumentation (Surgery) Number of levels in
      decompression/fusion (Surgery) Blood transfusion (Surgery) Type of incision closure -
      staples/suture (Surgery) Procedure details - Spine Surgical Invasiveness Index (Surgery)

      Hospital Stay:

      Admission Date (Admission) Discharge Date (Discharge) ICU admission pre-op (Admission) ICU
      admission post-op (Admission) Antibiotic Use (Discharge)

      Wound:

      Exudate (Follow-up) Erythema (Follow-up) Separation of deep tissues (Follow-up)

      Dressing Factors:

      Dressing Supply Utilization (Discharge)

      Data for each patient will be collected using the patient's hospital chart and visual
      inspection of the wound by a clinician. One questionnaire, the EQ5D, will be completed by
      study participants, with the help of a research assistant at Baseline (after obtaining
      consent), on Post-operative Day 7, Day 14 and Week 6. Participants will also be asked to
      complete this questionnaire if they have any unscheduled/unplanned encounters related to the
      occurrence of either a primary (SSI) or secondary (dehiscence/seroma) outcome during the
      study period.

      METHODOLOGY:

      Elective patients (revision and some metastatic cases) will be introduced to the study at the
      time of surgical consent by a member of the research team. Emergent patients (all trauma and
      most metastatic cases) will be introduced to the study pre-operatively in the Emergency
      Department or in the Orthopaedic Clinic by a member of the research team. Study participants
      will be randomized prior to surgery to receive either the Prevena™ System or standard wound
      care.

      All consenting participants will be randomized, based on the three primary diagnostic groups
      (revision surgery, metastatic disease or fracture with deficit). Study participants who
      receive the 'standard wound care' will have the dressing changed 3 days after their surgery
      and will have study encounters on Post-operative Day 7, Day 14 and Week 6 for wound
      inspection, dressing change (Day 7) and suture/staple removal (Day 14). Study participants
      who receive the Prevena™ System will have the same schedule of study encounters for wound
      inspection (Post-operative Day 7, Day 14 and Week 6). The Prevena™ System will be removed on
      Day 7 and a dry, sterile dressing will be applied. On Day 14 sutures/staples will be removed.

      Patients who have not yet been discharged at the time of the scheduled study encounter will
      be seen in hospital. Patients who have been discharged prior to any scheduled study
      encounters will be seen in a follow-up spine clinic.

      Participants will all be assigned a unique study ID and the treatment allocation will be
      hidden for the purposes of analysis. It will be impossible to blind physicians or
      participants to the treatment group given the obvious difference in appearance of the
      Prevena™ System versus standard wound dressing.

      STATISTICS:

      A power calculation has been performed to determine the number of participants required. This
      analysis has presumed an incidence of SSI of 15% (based on an averaging calculation of
      published data for these high risk groups), and used a 2-tailed analysis, assuming a power of
      0.8 and a Type I error of 5%. For a 50% decrease in primary outcome rates, Surgical Site
      Infection, (15% to 7.5%), 275 participants per group will be required. The pilot data
      generated from the proposed study will allow for refinement of this target recruitment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Consenting patients will be randomized to receive either standard sterile wound dressing or the Prevena™ System at the time of closure of the surgical wound.
primary purpose: Treatment
masking: None (Open Label)
masking description: The treatment allocation will be hidden for the purposes of analysis. It will be impossible to blind physicians or participants to the treatment group given the obvious difference in appearance of the Prevena™ System versus standard wound dressing.
measure: Rate of acute post-operative Surgical Site Infection (SSI)
time frame: 6 weeks
description: The incidence rate of SSI for patients with the Prevena™ System will be compared to those with the standard dressing.
measure: Post operative wound seroma or dehiscence
time frame: 1 week
description: The incidence of wounds requiring aspiration, surgical exploration, or incision repair for patients with the Prevena™ System will be compared to those with the standard dressing.
measure: Resource time commitment
time frame: 2 weeks
description: The time and resource commitment for post-operative, in-hospital, wound management for patients with the Prevena™ System will be compared to those with the standard dressing. This data is collected on a standardized log sheet appended to the nursing folio.
measure: Return visits
time frame: 6 weeks
description: The number of unanticipated post-op clinic visits, hospital readmissions and, emergency department/urgent-unplanned clinic evaluations for patients with the Prevena™ System will be compared to those with the standard dressing.
arm group label: Standard sterile wound dressing
arm group type: Placebo Comparator
description: Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
arm group label: Prevena™ system
arm group type: Active Comparator
description: The Prevena™ System is indicated for use over clean, closed incisions that continue to drain following sutured or stapled closure. It acts by removing exudate, helping hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment, until it is removed at Post-Operative Day 7.
intervention type: Device
intervention name: Prevena™ system
description: The Prevena™ System acts by removing exudate from a clean, closed incision. It helps hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.
arm group label: Prevena™ system
intervention type: Other
intervention name: Standard sterile wound dressing
description: Standard wound care involves the application of an occlusive dressing in the operating room.
arm group label: Standard sterile wound dressing
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Surgical Wound Infection