<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/NCT01704924</url>
  </required_header>
  <id_info>
    <org_study_id>KCI-2011-8268</org_study_id>
    <nct_id>NCT01704924</nct_id>
  </id_info>
  <brief_title>Prospective Observation of Wound Healing With Prevena Incision Management System</brief_title>
  <official_title>Prospective Observation of Wound Healing With Prevena Incision Management System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to assess the quality of wound healing in abdominal scars with and without&#xD;
      the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved&#xD;
      wound healing with less swelling, bruising, and inflammation, as well as less potential for&#xD;
      infection, seroma, and dehiscence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The quality of wound healing can be of the utmost importance for patients undergoing large&#xD;
      abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease&#xD;
      seroma and infection rates in high risk patients. This study aims to quantify the effect, if&#xD;
      any, that negative pressure wound therapy has on closed incisions. The technology may provide&#xD;
      benefits even in lower risk patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No study subjects enrolled, Investigator decided to cancel the project&#xD;
  </why_stopped>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scarring</measure>
    <time_frame>0-6 months</time_frame>
    <description>Assess quality of scar: hypertrophy, hyperpigmentation, etc</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Scarring</condition>
  <arm_group>
    <arm_group_label>Prevena</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Incision with prevena device overlying</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prevena device is not used</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prevena</intervention_name>
    <description>Device will be applied at end of procedure over closed incision</description>
    <arm_group_label>Prevena</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard of Care Dressing</intervention_name>
    <description>Dressing applied as Standard of Care</description>
    <arm_group_label>Standard of Care dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  abdominal procedure with incision &gt;20cm&#xD;
&#xD;
          -  must be &gt;18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  history of allergy or reaction to adhesives&#xD;
&#xD;
          -  pregnant or anticipated pregnancy within 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory Evans, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of California Irvine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California at Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.kci1.com/KCI1/prevena</url>
    <description>Prevena Product Website</description>
  </link>
  <reference>
    <citation>Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.</citation>
    <PMID>21761149</PMID>
  </reference>
  <reference>
    <citation>Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.</citation>
    <PMID>21804414</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>October 9, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>January 17, 2018</last_update_submitted>
  <last_update_submitted_qc>January 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Gregory R. Evans</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Prevena</keyword>
  <keyword>negative pressure wound therapy</keyword>
  <keyword>Incisional wound vac</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cicatrix</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/NCT01704924
org study id: KCI-2011-8268
nct id: NCT01704924
lead sponsor: 
has dmc: No
This study aims to assess the quality of wound healing in abdominal scars with and without
      the Prevena Incision Management System. The hypothesis is that Prevena will lead to improved
      wound healing with less swelling, bruising, and inflammation, as well as less potential for
      infection, seroma, and dehiscence.
The quality of wound healing can be of the utmost importance for patients undergoing large
      abdominal surgery. Incisional negative pressure wound therapy has been observed to decrease
      seroma and infection rates in high risk patients. This study aims to quantify the effect, if
      any, that negative pressure wound therapy has on closed incisions. The technology may provide
      benefits even in lower risk patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Scarring
time frame: 0-6 months
description: Assess quality of scar: hypertrophy, hyperpigmentation, etc
arm group label: Prevena
arm group type: Active Comparator
description: Incision with prevena device overlying
arm group label: Standard of Care dressing
arm group type: Active Comparator
description: Prevena device is not used
intervention type: Device
intervention name: Prevena
description: Device will be applied at end of procedure over closed incision
arm group label: Prevena
intervention type: Procedure
intervention name: Standard of Care Dressing
description: Dressing applied as Standard of Care
arm group label: Standard of Care dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory Evans, MD
role: Principal Investigator
affiliation: The University of California Irvine
facility: 
country: United States
url: http://www.kci1.com/KCI1/prevena
description: Prevena Product Website
citation: Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15.
PMID: 21761149
citation: Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.
PMID: 21804414
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Gregory R. Evans
investigator title: Professor
mesh term: Cicatrix