<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/NCT04455724</url>
  </required_header>
  <id_info>
    <org_study_id>8183</org_study_id>
    <nct_id>NCT04455724</nct_id>
  </id_info>
  <brief_title>Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair</brief_title>
  <acronym>N-PITH</acronym>
  <official_title>Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</source>
  <oversight_info>
    <has_dmc>No</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>
      The investigators are testing the ability of vacuum dressings to improve wound healing for&#xD;
      patients having large hernias surgically repaired who are at risk of having wound&#xD;
      complications. The trial will randomly be giving some patients having this surgery the vacuum&#xD;
      dressing and some a standard dressing and observing how their wounds heal in hospital and at&#xD;
      follow-up appointments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicentre, clinical randomized controlled trial comparing the use of&#xD;
      incisional negative pressure wound therapy versus standard sterile dressings in high-risk&#xD;
      ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent&#xD;
      ventral hernia repair who have risk factors for surgical wound complications and randomizing&#xD;
      them to either receive a PREVENA incisional negative pressure wound therapy system dressing&#xD;
      for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The&#xD;
      primary outcome will be a composite of a variety of surgical site complications including&#xD;
      wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia&#xD;
      recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of&#xD;
      treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will&#xD;
      include perceived difference in Quality of Life and cost-effectiveness of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Given the physical differences in the negative pressure wound therapy systems compared to standard sterile dressings, patient participants and care providers will not be able to be blinded. Ultrasound evaluators and statisticians, however, will be.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical Site Complications</measure>
    <time_frame>First 3 months post-operatively</time_frame>
    <description>Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life after surgery: survey</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>Quality of life as measured using the Hernia-Related Quality of Life Survey (HerQLes). Scoring is out of 100, with higher scores indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>Cost in dollars per quality-adjusted life year, measured using hospital length of stay, cost of complications, and cost of intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Negative Pressure Incisional Wound Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A PREVENA™ PEEL &amp; PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard sterile dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Negative pressure incisional wound therapy</intervention_name>
    <description>A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.</description>
    <arm_group_label>Negative Pressure Incisional Wound Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard sterile dressing</intervention_name>
    <description>A standard, sterile island dressing</description>
    <arm_group_label>Standard sterile dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm&#xD;
             in largest diameter&#xD;
&#xD;
          2. have one or more of the following risk factors for post-operative surgical site&#xD;
             complications:&#xD;
&#xD;
               1. Body Mass Index (BMI) greater than or equal to 30&#xD;
&#xD;
               2. diagnosis of diabetes mellitus (either type I or II)&#xD;
&#xD;
               3. previous history of hernia recurrence&#xD;
&#xD;
               4. active smoker&#xD;
&#xD;
               5. presence of colostomy or ileostomy&#xD;
&#xD;
               6. age greater than 64&#xD;
&#xD;
               7. chronic obstructive pulmonary disease&#xD;
&#xD;
               8. chronic kidney disease&#xD;
&#xD;
               9. clinically immunocompromised.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the abdomen is left open post-operatively, or&#xD;
&#xD;
          2. if the patient has a sensitivity to silver.&#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>Christopher E Blewett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nathan E How, MD</last_name>
    <phone>613-539-1337</phone>
    <email>nathan.how@medportal.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christopher Blewett, MD</last_name>
    <phone>289 606 1333</phone>
    <email>blewettc@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Niagara Health St. Catharines Site</name>
      <address>
        <city>St. Catharines</city>
        <state>Ontario</state>
        <zip>L2R 2A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nathan How, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Lindmark M, Strigard K, Lowenmark T, Dahlstrand U, Gunnarsson U. Risk Factors for Surgical Complications in Ventral Hernia Repair. World J Surg. 2018 Nov;42(11):3528-3536. doi: 10.1007/s00268-018-4642-6.</citation>
    <PMID>29700567</PMID>
  </reference>
  <reference>
    <citation>Nguyen MT, Berger RL, Hicks SC, Davila JA, Li LT, Kao LS, Liang MK. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surg. 2014 May;149(5):415-21. doi: 10.1001/jamasurg.2013.5014.</citation>
    <PMID>24554114</PMID>
  </reference>
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    <citation>Lee L, Mata J, Landry T, Khwaja KA, Vassiliou MC, Fried GM, Feldman LS. A systematic review of synthetic and biologic materials for abdominal wall reinforcement in contaminated fields. Surg Endosc. 2014 Sep;28(9):2531-46. doi: 10.1007/s00464-014-3499-5. Epub 2014 Mar 12.</citation>
    <PMID>24619334</PMID>
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    <citation>Castro PM, Rabelato JT, Monteiro GG, del Guerra GC, Mazzurana M, Alvarez GA. Laparoscopy versus laparotomy in the repair of ventral hernias: systematic review and meta-analysis. Arq Gastroenterol. 2014 Jul-Sep;51(3):205-11. doi: 10.1590/s0004-2803201400030008.</citation>
    <PMID>25296080</PMID>
  </reference>
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    <citation>Fischer JP, Wink JD, Nelson JA, Kovach SJ 3rd. Among 1,706 cases of abdominal wall reconstruction, what factors influence the occurrence of major operative complications? Surgery. 2014 Feb;155(2):311-9. doi: 10.1016/j.surg.2013.08.014.</citation>
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    <citation>Lovecchio F, Farmer R, Souza J, Khavanin N, Dumanian GA, Kim JY. Risk factors for 30-day readmission in patients undergoing ventral hernia repair. Surgery. 2014 Apr;155(4):702-10. doi: 10.1016/j.surg.2013.12.021. Epub 2013 Dec 25.</citation>
    <PMID>24612622</PMID>
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    <citation>Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017 May;96(1):1-15. doi: 10.1016/j.jhin.2017.03.004. Epub 2017 Mar 8.</citation>
    <PMID>28410761</PMID>
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    <PMID>27681586</PMID>
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    <citation>Gheorghe A, Moran G, Duffy H, Roberts T, Pinkney T, Calvert M. Health Utility Values Associated with Surgical Site Infection: A Systematic Review. Value Health. 2015 Dec;18(8):1126-37. doi: 10.1016/j.jval.2015.08.004. Epub 2015 Sep 26.</citation>
    <PMID>26686800</PMID>
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    <citation>Guest JF, Fuller GW, Vowden P. Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study. BMJ Open. 2018 Dec 14;8(12):e022591. doi: 10.1136/bmjopen-2018-022591.</citation>
    <PMID>30552253</PMID>
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  <reference>
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    <citation>Capobianco CM, Zgonis T. An overview of negative pressure wound therapy for the lower extremity. Clin Podiatr Med Surg. 2009 Oct;26(4):619-31. doi: 10.1016/j.cpm.2009.08.002.</citation>
    <PMID>19778692</PMID>
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    <citation>Ma Z, Li Z, Shou K, Jian C, Li P, Niu Y, Qi B, Yu A. Negative pressure wound therapy: Regulating blood flow perfusion and microvessel maturation through microvascular pericytes. Int J Mol Med. 2017 Nov;40(5):1415-1425. doi: 10.3892/ijmm.2017.3131. Epub 2017 Sep 13.</citation>
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    <PMID>19541009</PMID>
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    <citation>Scherer SS, Pietramaggiori G, Mathews JC, Prsa MJ, Huang S, Orgill DP. The mechanism of action of the vacuum-assisted closure device. Plast Reconstr Surg. 2008 Sep;122(3):786-797. doi: 10.1097/PRS.0b013e31818237ac.</citation>
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    <citation>Moues CM, Vos MC, van den Bemd GJ, Stijnen T, Hovius SE. Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial. Wound Repair Regen. 2004 Jan-Feb;12(1):11-7. doi: 10.1111/j.1067-1927.2004.12105.x.</citation>
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    <citation>Dohmen PM, Markou T, Ingemansson R, Rotering H, Hartman JM, van Valen R, Brunott M, Segers P. Use of incisional negative pressure wound therapy on closed median sternal incisions after cardiothoracic surgery: clinical evidence and consensus recommendations. Med Sci Monit. 2014 Oct 4;20:1814-25. doi: 10.12659/MSM.891169.</citation>
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    <citation>Rodriguez-Unda N, Soares KC, Azoury SC, Baltodano PA, Hicks CW, Burce KK, Cornell P, Cooney CM, Eckhauser FE. Negative-Pressure Wound Therapy in the Management of High-Grade Ventral Hernia Repairs. J Gastrointest Surg. 2015 Nov;19(11):2054-61. doi: 10.1007/s11605-015-2894-0. Epub 2015 Aug 4.</citation>
    <PMID>26239514</PMID>
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    <citation>Ren H, Li Y. Severe complications after negative pressure wound therapy in burned wounds: two case reports. Ther Clin Risk Manag. 2014 Jul 1;10:513-6. doi: 10.2147/TCRM.S66117. eCollection 2014.</citation>
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    <citation>Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst Rev. 2019 Mar 26;3(3):CD009261. doi: 10.1002/14651858.CD009261.pub4.</citation>
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    <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>
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    <PMID>22549748</PMID>
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    <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>
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  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 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>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</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/NCT04455724
org study id: 8183
nct id: NCT04455724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The investigators are testing the ability of vacuum dressings to improve wound healing for
      patients having large hernias surgically repaired who are at risk of having wound
      complications. The trial will randomly be giving some patients having this surgery the vacuum
      dressing and some a standard dressing and observing how their wounds heal in hospital and at
      follow-up appointments.
This study is a multicentre, clinical randomized controlled trial comparing the use of
      incisional negative pressure wound therapy versus standard sterile dressings in high-risk
      ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent
      ventral hernia repair who have risk factors for surgical wound complications and randomizing
      them to either receive a PREVENA incisional negative pressure wound therapy system dressing
      for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The
      primary outcome will be a composite of a variety of surgical site complications including
      wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia
      recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of
      treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will
      include perceived difference in Quality of Life and cost-effectiveness of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Given the physical differences in the negative pressure wound therapy systems compared to standard sterile dressings, patient participants and care providers will not be able to be blinded. Ultrasound evaluators and statisticians, however, will be.
measure: Surgical Site Complications
time frame: First 3 months post-operatively
description: Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.
measure: Quality of life after surgery: survey
time frame: 3 months post-operatively
description: Quality of life as measured using the Hernia-Related Quality of Life Survey (HerQLes). Scoring is out of 100, with higher scores indicating better quality of life.
measure: Cost-effectiveness
time frame: 3 months post-operatively
description: Cost in dollars per quality-adjusted life year, measured using hospital length of stay, cost of complications, and cost of intervention
arm group label: Negative Pressure Incisional Wound Therapy
arm group type: Experimental
description: A PREVENA™ PEEL & PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site.
arm group label: Standard sterile dressing
arm group type: Active Comparator
description: A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge.
intervention type: Device
intervention name: Negative pressure incisional wound therapy
description: A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
arm group label: Negative Pressure Incisional Wound Therapy
intervention type: Device
intervention name: Standard sterile dressing
description: A standard, sterile island dressing
arm group label: Standard sterile dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher E Blewett, MD
role: Principal Investigator
affiliation: McMaster University
last name: Nathan E How, MD
phone: 613-539-1337
email: nathan.how@medportal.ca
last name: Christopher Blewett, MD
phone: 289 606 1333
email: blewettc@gmail.com
facility: 
status: Recruiting
contact: 
country: Canada
citation: Lindmark M, Strigard K, Lowenmark T, Dahlstrand U, Gunnarsson U. Risk Factors for Surgical Complications in Ventral Hernia Repair. World J Surg. 2018 Nov;42(11):3528-3536. doi: 10.1007/s00268-018-4642-6.
PMID: 29700567
citation: Nguyen MT, Berger RL, Hicks SC, Davila JA, Li LT, Kao LS, Liang MK. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surg. 2014 May;149(5):415-21. doi: 10.1001/jamasurg.2013.5014.
PMID: 24554114
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responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral
sharing ipd: No