<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/NCT03773575</url>
  </required_header>
  <id_info>
    <org_study_id>18P.577</org_study_id>
    <nct_id>NCT03773575</nct_id>
  </id_info>
  <brief_title>Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications</brief_title>
  <acronym>PREVENA-AMP</acronym>
  <official_title>Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputation Wound Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thomas Jefferson University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Acelity</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Thomas Jefferson University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled&#xD;
      trial with a goal of evaluating the impact of a closed incision negative pressure dressing&#xD;
      (PREVENA) on incidence of post-operative wound complications and medical costs in patients&#xD;
      undergoing lower extremity amputation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to&#xD;
      evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL &amp; PLACE™&#xD;
      Dressing Kit) on incidence of post-operative wound complications in patients undergoing&#xD;
      above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately&#xD;
      five (5) participating sites will be randomized to receive either the Prevena dressing or a&#xD;
      standard care dressing. The incision will be assessed for complications at post-op day 5 or&#xD;
      day 6 and at approximately 30 days after discharge. The primary outcome of this study is&#xD;
      reported wound complications, including dehiscence (opening of the incision), seroma, lymph&#xD;
      leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood&#xD;
      supply), and necrosis (tissue death) A major complication is defined as any wound&#xD;
      complication requiring intravenous or oral antibiotics, reoperation and/or hospital&#xD;
      readmission. All data (demographics, medical history, and clinical outcomes) will be&#xD;
      collected via medical record review&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">August 15, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2024</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall rate of wound complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Presence of any of the following post-procedure:&#xD;
Dehiscence (skin or fascia)&#xD;
Seroma&#xD;
Lymph leak&#xD;
Infection (superficial or deep, using CDC Surgical Site Infection criteria)&#xD;
Hematoma&#xD;
Ischemia&#xD;
Necrosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay (LOS)</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day Return to Operating Room (ROR)</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day hospital readmissions</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Rehospitalization for wound complication within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence rates of wound complications</measure>
    <time_frame>30 days post procedure</time_frame>
    <description>Individual rates of the incidence of each of the following:&#xD;
Dehiscence (skin or fascia)&#xD;
Seroma&#xD;
Lymph leak&#xD;
Infection (superficial or deep, using CDC Surgical Site Infection criteria)&#xD;
Hematoma&#xD;
Ischemia&#xD;
Necrosis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>30-day hospitalization costs</measure>
    <time_frame>admission to discharge; 30 days post procedure</time_frame>
    <description>Index hospitalization costs as well as all readmission days within 30d related to any wound complication</description>
  </other_outcome>
  <other_outcome>
    <measure>30-day hospital variable costs</measure>
    <time_frame>admission to discharge; 30 days post procedure</time_frame>
    <description>Variable costs (not charges) for each admission obtained from hospital administration</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Amputation</condition>
  <condition>Amputation; Postoperative, Sequelae</condition>
  <condition>Wound Dehiscence</condition>
  <condition>Seroma</condition>
  <condition>Wound Infection, Surgical</condition>
  <condition>Lymph Leakage</condition>
  <arm_group>
    <arm_group_label>Prevena</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PREVENA™ PEEL &amp; PLACE™ Dressing Kit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>sterile gauze dressing supplemented with an Ace wrap</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PREVENA™ PEEL &amp; PLACE™ Dressing Kit</intervention_name>
    <description>In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).</description>
    <arm_group_label>Prevena</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adults 18 years or older&#xD;
&#xD;
          2. Patients undergoing above-knee amputation (includes the revision of emergency&#xD;
             guillotine amputations)&#xD;
&#xD;
          3. Patients undergoing below-knee amputation (includes the revision of emergency&#xD;
             guillotine amputations)&#xD;
&#xD;
          4. Informed Consent signed by patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Minors under 18 years&#xD;
&#xD;
          2. Women who are pregnant or breastfeeding&#xD;
&#xD;
          3. Patients undergoing emergent or guillotine amputation&#xD;
&#xD;
          4. Patients having BOTH legs amputated&#xD;
&#xD;
          5. Patients with sensitivity to silver&#xD;
&#xD;
          6. Unwilling or unable to provide informed consent&#xD;
&#xD;
          7. Inability to comply with planned study procedures&#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>Paul DiMuzio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thomas Jefferson University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Melissa McCarey</last_name>
    <phone>215-503-7417</phone>
    <email>Melissa.McCarey@jefferson.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Westchester Medical Center</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher Hall</last_name>
      <email>Christopher.Hall2@wmchealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeontaik Kwon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University/Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa McCarey</last_name>
      <phone>215-503-7417</phone>
      <email>melissa.mccarey@jefferson.edu</email>
    </contact>
    <investigator>
      <last_name>Paul DiMuzio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dawn Salvatore, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Babak Abai, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Gemelli Hospital</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>8, 00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Federico Biscetti</last_name>
      <email>federico.biscetti@policlinicogemelli.it</email>
    </contact>
    <investigator>
      <last_name>Federico Biscetti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf</url>
    <description>National Healthcare Safety Network definition of Surgical Site Infection (SSI) Event</description>
  </link>
  <reference>
    <citation>Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15.</citation>
    <PMID>21840153</PMID>
  </reference>
  <reference>
    <citation>Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.</citation>
    <PMID>21723151</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>
  <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>Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.</citation>
    <PMID>23111014</PMID>
  </reference>
  <reference>
    <citation>Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.</citation>
    <PMID>26994715</PMID>
  </reference>
  <reference>
    <citation>Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.</citation>
    <PMID>30126781</PMID>
  </reference>
  <reference>
    <citation>O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.</citation>
    <PMID>497341</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 1, 2023</last_update_submitted>
  <last_update_submitted_qc>May 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</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>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03773575/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03773575
org study id: 18P.577
nct id: NCT03773575
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled
      trial with a goal of evaluating the impact of a closed incision negative pressure dressing
      (PREVENA) on incidence of post-operative wound complications and medical costs in patients
      undergoing lower extremity amputation.
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to
      evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™
      Dressing Kit) on incidence of post-operative wound complications in patients undergoing
      above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately
      five (5) participating sites will be randomized to receive either the Prevena dressing or a
      standard care dressing. The incision will be assessed for complications at post-op day 5 or
      day 6 and at approximately 30 days after discharge. The primary outcome of this study is
      reported wound complications, including dehiscence (opening of the incision), seroma, lymph
      leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood
      supply), and necrosis (tissue death) A major complication is defined as any wound
      complication requiring intravenous or oral antibiotics, reoperation and/or hospital
      readmission. All data (demographics, medical history, and clinical outcomes) will be
      collected via medical record review
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Overall rate of wound complications
time frame: 30 days post procedure
description: Presence of any of the following post-procedure:
Dehiscence (skin or fascia)
Seroma
Lymph leak
Infection (superficial or deep, using CDC Surgical Site Infection criteria)
Hematoma
Ischemia
Necrosis
measure: Length of stay (LOS)
time frame: 30 days post procedure
description: index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication
measure: 30-day Return to Operating Room (ROR)
time frame: 30 days post procedure
description: Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation
measure: 30-day hospital readmissions
time frame: 30 days post procedure
description: Rehospitalization for wound complication within 30 days
measure: Incidence rates of wound complications
time frame: 30 days post procedure
description: Individual rates of the incidence of each of the following:
Dehiscence (skin or fascia)
Seroma
Lymph leak
Infection (superficial or deep, using CDC Surgical Site Infection criteria)
Hematoma
Ischemia
Necrosis
measure: 30-day hospitalization costs
time frame: admission to discharge; 30 days post procedure
description: Index hospitalization costs as well as all readmission days within 30d related to any wound complication
measure: 30-day hospital variable costs
time frame: admission to discharge; 30 days post procedure
description: Variable costs (not charges) for each admission obtained from hospital administration
arm group label: Prevena
arm group type: Experimental
description: PREVENA™ PEEL & PLACE™ Dressing Kit
arm group label: Standard Care
arm group type: No Intervention
description: sterile gauze dressing supplemented with an Ace wrap
intervention type: Device
intervention name: PREVENA™ PEEL & PLACE™ Dressing Kit
description: In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).
arm group label: Prevena
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul DiMuzio, MD
role: Principal Investigator
affiliation: Thomas Jefferson University
last name: Melissa McCarey
phone: 215-503-7417
email: Melissa.McCarey@jefferson.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
country: United States
url: http://www.cdc.gov/nhsn/PDFs/pscManual/9pscSSIcurrent.pdf
description: National Healthcare Safety Network definition of Surgical Site Infection (SSI) Event
citation: Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15.
PMID: 21840153
citation: Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1.
PMID: 21723151
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
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: Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27.
PMID: 23111014
citation: Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.
PMID: 26994715
citation: Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17.
PMID: 30126781
citation: O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
PMID: 497341
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Wounds and Injuries
sharing ipd: No
provided document: 