<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/NCT03034213</url>
  </required_header>
  <id_info>
    <org_study_id>CA2017-002</org_study_id>
    <nct_id>NCT03034213</nct_id>
  </id_info>
  <brief_title>Gentrix™ Versus Biological or Prosthetic Mesh</brief_title>
  <official_title>Randomized, Controlled Trial Comparing Separation of Components Repair With Retrorectus Gentrix™ Surgical Matrix Versus Biological or Prosthetic Mesh for Open Ventral Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Integra LifeSciences Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of South Florida</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis for this study is complex incisional hernia repair using the separation of&#xD;
      components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will&#xD;
      lead to fewer incisional hernia recurrences and fewer wound complications compared to the&#xD;
      same incisional hernia repair techniques reinforced with other prosthetic or&#xD;
      biologically-derived mesh.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biological and prosthetic mesh products are extensively used in hernia repairs. However, they&#xD;
      also have their limitations. Potential complications associated with prosthetic mesh for&#xD;
      hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation,&#xD;
      adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby&#xD;
      organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential&#xD;
      complications associated with biological mesh include: adverse inflammatory response, laxity,&#xD;
      eventration, and recurrent herniation. This study is a two-arm, randomized, controlled trial&#xD;
      comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus&#xD;
      biological or prosthetic mesh for open ventral hernia repair.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Cease of Funding&#xD;
  </why_stopped>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">June 16, 2021</completion_date>
  <primary_completion_date type="Actual">June 16, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of incisional hernia recurrence</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to incisional hernia recurrence</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of wound complications</measure>
    <time_frame>90 days from study incisional hernia repair</time_frame>
    <description>Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of enterocutaneous fistula formation</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Carolinas Comfort Scale score</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
    <description>Patient-centered outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Visual Analog Scale score</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
    <description>Patient-centered outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean mesh deployment time</measure>
    <time_frame>duration of surgery (incisional hernia repair)</time_frame>
    <description>Defined as the time mesh preparation starts to time mesh placement ends</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean procedure time</measure>
    <time_frame>duration of surgery (incisional hernia repair)</time_frame>
    <description>Defined as time of incision to time of closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total cost of hospitalization for primary admission</measure>
    <time_frame>duration of hospitalization for incisional hernia repair</time_frame>
    <description>Defined as from surgery to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total cost of surgery for primary admission</measure>
    <time_frame>duration of surgery (incisional hernia repair)</time_frame>
    <description>Defined as from preoperative preparation to anesthesia discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total cost of narcotic usage for primary admission</measure>
    <time_frame>duration of hospitalization for incisional hernia repair</time_frame>
    <description>Defined as narcotic use from surgery to hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean total cost of readmissions</measure>
    <time_frame>2 years from study incisional hernia repair</time_frame>
    <description>Defined as any hospital readmissions related to ventral hernia complications or recurrence</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Ventral Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gentrix(TM) Surgical Matrix</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care mesh</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Gentrix™ Surgical Matrix (Treatment)</intervention_name>
    <description>Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)</intervention_name>
    <description>A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients ≥ 18 years old.&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status classification of I, II,&#xD;
             III or IV.&#xD;
&#xD;
          -  Able to provide informed consent in English or Spanish.&#xD;
&#xD;
          -  Stated willingness to comply with all study procedures and availability for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Body Mass Index (BMI) =&lt; 45.&#xD;
&#xD;
          -  Incisional hernia from a midline incision ≥ 4 cm in greatest diameter, or any&#xD;
             recurrent incisional hernia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other type of ventral hernia, such as umbilical, epigastric or Spigelian hernia.&#xD;
&#xD;
          -  Pregnant, breastfeeding, or unwilling to practice birth control during participation&#xD;
             in the study, if applicable.&#xD;
&#xD;
          -  Allergy or hypersensitivity to materials in porcine-based study products, biological&#xD;
             or prosthetic meshes, or personal preference.&#xD;
&#xD;
          -  Contraindications to general anesthesia.&#xD;
&#xD;
          -  Patient undergoing any emergency surgery prior to treatment.&#xD;
&#xD;
          -  Severe comorbid conditions likely to limit survival to less than 3 years in the&#xD;
             opinion of the Investigator.&#xD;
&#xD;
          -  Have abdominal loss of domain such that the operation would be impractical or would&#xD;
             adversely affect respiratory or cardiovascular function to an unacceptable degree in&#xD;
             the opinion of the Investigator.&#xD;
&#xD;
          -  Inability to close the fascia primarily with abdominal wall mobilization or component&#xD;
             separation; confirmed intra-operatively.&#xD;
&#xD;
          -  History of malignancy within the past 5 years except for non-melanoma skin cancer.&#xD;
&#xD;
          -  Known active malignancy present and/or had chemotherapy 12 weeks prior to screening or&#xD;
             planned chemotherapy within 12 weeks of treatment with exception of basal cell&#xD;
             carcinoma, squamous cell carcinoma, or prostate cancer in situ.&#xD;
&#xD;
          -  Cirrhosis with or without ascites.&#xD;
&#xD;
          -  Received high dose steroids (&gt;/=100mg of prednisone) within the past 6 weeks of&#xD;
             screening.&#xD;
&#xD;
          -  Uncontrolled diabetes (i.e. known HbA1C value &gt; 7% within the prior 6 weeks of the&#xD;
             Screening Visit).&#xD;
&#xD;
          -  History of drug addiction (recreational drugs, prescription drugs or alcohol) that in&#xD;
             the Investigator's opinion may interfere with protocol assessments and/or the&#xD;
             subject's ability to complete the required follow up.&#xD;
&#xD;
          -  Serious or active medical or psychiatric condition which, in the opinion of the&#xD;
             Investigator, may interfere with treatment, assessment, or compliance with the&#xD;
             protocol.&#xD;
&#xD;
          -  Suspected presence of enterocutaneous fistula.&#xD;
&#xD;
          -  Planned use of external VAC dressing intra-operatively.&#xD;
&#xD;
          -  Suspected bowel obstruction (partial or intermittent), strangulation, peritonitis, or&#xD;
             perforation.&#xD;
&#xD;
          -  Active necrotizing fasciitis or any other known active local or systemic infection.&#xD;
&#xD;
          -  Subject report of participation in an investigational drug or device study that would&#xD;
             impact the safety or scientific integrity of this study (in the opinion of the&#xD;
             Investigator and with the approval of the Sponsor) within the past 6 weeks prior to&#xD;
             treatment in this trial.&#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>Vic Velanovich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida - South Tampa Campus</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida Morsani Center for Advanced Health Care</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>FitzGerald JF, Kumar AS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec;27(4):140-8. doi: 10.1055/s-0034-1394155.</citation>
    <PMID>26106284</PMID>
  </reference>
  <reference>
    <citation>Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.</citation>
    <PMID>9382393</PMID>
  </reference>
  <results_reference>
    <citation>Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.</citation>
    <PMID>26206646</PMID>
  </results_reference>
  <results_reference>
    <citation>Fekkes JF, Velanovich V. Amelioration of the effects of obesity on short-term postoperative complications of laparoscopic and open ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2015 Apr;25(2):151-7. doi: 10.1097/SLE.0000000000000100.</citation>
    <PMID>25222715</PMID>
  </results_reference>
  <results_reference>
    <citation>Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.</citation>
    <PMID>21904861</PMID>
  </results_reference>
  <results_reference>
    <citation>Fischer JP, Wink JD, Tuggle CT, Nelson JA, Kovach SJ. Wound risk assessment in ventral hernia repair: generation and internal validation of a risk stratification system using the ACS-NSQIP. Hernia. 2015 Feb;19(1):103-11. doi: 10.1007/s10029-014-1318-5. Epub 2014 Dec 4.</citation>
    <PMID>25472771</PMID>
  </results_reference>
  <results_reference>
    <citation>Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.</citation>
    <PMID>18387468</PMID>
  </results_reference>
  <results_reference>
    <citation>Nielsen K, Poelman MM, den Bakker FM, van der Ploeg T, Bonjer HJ, Schreurs WH. Comparison of the Dutch and English versions of the Carolinas Comfort Scale: a specific quality-of-life questionnaire for abdominal hernia repairs with mesh. Hernia. 2014 Aug;18(4):459-64. doi: 10.1007/s10029-013-1173-9. Epub 2013 Oct 29.</citation>
    <PMID>24166693</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mesh</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</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/NCT03034213
org study id: CA2017-002
nct id: NCT03034213
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The hypothesis for this study is complex incisional hernia repair using the separation of
      components technique reinforced with retrorectus placement of Gentrix™ Surgical Matrix will
      lead to fewer incisional hernia recurrences and fewer wound complications compared to the
      same incisional hernia repair techniques reinforced with other prosthetic or
      biologically-derived mesh.
Biological and prosthetic mesh products are extensively used in hernia repairs. However, they
      also have their limitations. Potential complications associated with prosthetic mesh for
      hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation,
      adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby
      organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential
      complications associated with biological mesh include: adverse inflammatory response, laxity,
      eventration, and recurrent herniation. This study is a two-arm, randomized, controlled trial
      comparing separation of components repair with retrorectus Gentrix™ Surgical Matrix versus
      biological or prosthetic mesh for open ventral hernia repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of incisional hernia recurrence
time frame: 2 years from study incisional hernia repair
measure: Time to incisional hernia recurrence
time frame: 2 years from study incisional hernia repair
measure: Incidence of wound complications
time frame: 90 days from study incisional hernia repair
description: Complications of interest: surgical site infections, seroma formation, and wound dehiscence or skin separation
measure: Incidence of enterocutaneous fistula formation
time frame: 2 years from study incisional hernia repair
measure: Mean Carolinas Comfort Scale score
time frame: 2 years from study incisional hernia repair
description: Patient-centered outcome
measure: Mean Visual Analog Scale score
time frame: 2 years from study incisional hernia repair
description: Patient-centered outcome
measure: Mean mesh deployment time
time frame: duration of surgery (incisional hernia repair)
description: Defined as the time mesh preparation starts to time mesh placement ends
measure: Mean procedure time
time frame: duration of surgery (incisional hernia repair)
description: Defined as time of incision to time of closure
measure: Mean total cost of hospitalization for primary admission
time frame: duration of hospitalization for incisional hernia repair
description: Defined as from surgery to hospital discharge
measure: Mean total cost of surgery for primary admission
time frame: duration of surgery (incisional hernia repair)
description: Defined as from preoperative preparation to anesthesia discharge
measure: Mean total cost of narcotic usage for primary admission
time frame: duration of hospitalization for incisional hernia repair
description: Defined as narcotic use from surgery to hospital discharge
measure: Mean total cost of readmissions
time frame: 2 years from study incisional hernia repair
description: Defined as any hospital readmissions related to ventral hernia complications or recurrence
arm group label: Treatment
arm group type: Active Comparator
description: Gentrix(TM) Surgical Matrix
arm group label: Control
arm group type: Active Comparator
description: Standard of care mesh
intervention type: Device
intervention name: Gentrix™ Surgical Matrix (Treatment)
description: Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.
arm group label: Treatment
intervention type: Device
intervention name: Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)
description: A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vic Velanovich, MD
role: Principal Investigator
affiliation: University of South Florida
facility: 
facility: 
facility: 
country: United States
citation: FitzGerald JF, Kumar AS. Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons? Clin Colon Rectal Surg. 2014 Dec;27(4):140-8. doi: 10.1055/s-0034-1394155.
PMID: 26106284
citation: Zhou XH, Melfi CA, Hui SL. Methods for comparison of cost data. Ann Intern Med. 1997 Oct 15;127(8 Pt 2):752-6. doi: 10.7326/0003-4819-127-8_part_2-199710151-00063.
PMID: 9382393
citation: Holihan JL, Alawadi Z, Martindale RG, Roth JS, Wray CJ, Ko TC, Kao LS, Liang MK. Adverse Events after Ventral Hernia Repair: The Vicious Cycle of Complications. J Am Coll Surg. 2015 Aug;221(2):478-85. doi: 10.1016/j.jamcollsurg.2015.04.026. Epub 2015 May 9.
PMID: 26206646
citation: Fekkes JF, Velanovich V. Amelioration of the effects of obesity on short-term postoperative complications of laparoscopic and open ventral hernia repair. Surg Laparosc Endosc Percutan Tech. 2015 Apr;25(2):151-7. doi: 10.1097/SLE.0000000000000100.
PMID: 25222715
citation: Poulose BK, Shelton J, Phillips S, Moore D, Nealon W, Penson D, Beck W, Holzman MD. Epidemiology and cost of ventral hernia repair: making the case for hernia research. Hernia. 2012 Apr;16(2):179-83. doi: 10.1007/s10029-011-0879-9. Epub 2011 Sep 9.
PMID: 21904861
citation: Fischer JP, Wink JD, Tuggle CT, Nelson JA, Kovach SJ. Wound risk assessment in ventral hernia repair: generation and internal validation of a risk stratification system using the ACS-NSQIP. Hernia. 2015 Feb;19(1):103-11. doi: 10.1007/s10029-014-1318-5. Epub 2014 Dec 4.
PMID: 25472771
citation: Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1.
PMID: 18387468
citation: Nielsen K, Poelman MM, den Bakker FM, van der Ploeg T, Bonjer HJ, Schreurs WH. Comparison of the Dutch and English versions of the Carolinas Comfort Scale: a specific quality-of-life questionnaire for abdominal hernia repairs with mesh. Hernia. 2014 Aug;18(4):459-64. doi: 10.1007/s10029-013-1173-9. Epub 2013 Oct 29.
PMID: 24166693
responsible party type: Sponsor
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No