<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/NCT04417140</url>
  </required_header>
  <id_info>
    <org_study_id>LSUHSC-NO IRB # 19-174</org_study_id>
    <nct_id>NCT04417140</nct_id>
  </id_info>
  <brief_title>A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis</brief_title>
  <acronym>NO-HERNIA</acronym>
  <official_title>A Prospective, Double-Blinded, Randomized Controlled Trial of Dehydrated Human Amniotic-Chorionic Membrane for Incisional Hernia Prophylaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center in New Orleans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LSUHSC-NO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Louisiana State University Health Sciences Center in New Orleans</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, no standard of care exists to prevent incisional hernias (IH). This study will&#xD;
      compare how frequently IH develop in standard abdominal closures vs. abdominal closures with&#xD;
      dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of&#xD;
      IH.&#xD;
&#xD;
      If patients decide to participate in this study, they will be randomly assigned to one of two&#xD;
      study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The&#xD;
      assignment will be made by computer program and is completely random. Patients are not&#xD;
      informed of which arm they are assigned.&#xD;
&#xD;
      Arm A (Treatment Arm): dHACM Patients enrolled in this arm will have a thin sheet of dHACM&#xD;
      placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human&#xD;
      Amniotic-Chorion Membrane. It is a FDA-registered healing adjunct that has been applied in a&#xD;
      broad range of diseases including wounds, plantar fasciitis and burns.&#xD;
&#xD;
      Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure.&#xD;
&#xD;
      Data collection will be performed at routine follow-up outpatient clinic visits with the&#xD;
      primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will&#xD;
      see a surgeon who is blinded to the randomization. This surgeon will perform a painless&#xD;
      handheld ultrasound examination of the incision site.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two million laparotomies are performed annually in the United States (US). Following these&#xD;
      surgeries, the incidence of new incisional hernias (IH) is estimated at 400,000 cases per&#xD;
      year. These hernias are a major source of morbidity and mortality for patients, and they&#xD;
      result in $6-10 billion per year in healthcare costs. Our multidisciplinary hernia prevention&#xD;
      group has identified a novel IH prevention strategy in the form of dehydrated human&#xD;
      amniotic-chorionic membrane (dHACM). We previously showed that dHACM prevents IH in animal&#xD;
      models, and subsequently in a prospective cohort of high-risk patients.&#xD;
&#xD;
      The purpose of this trial is to quantify the efficacy of dHACM in IH prophylaxis by&#xD;
      performing a prospective, double-blinded randomized controlled trial. Our specific aim is to&#xD;
      test the hypothesis that augmentation of standard abdominal fascia closures with&#xD;
      prophylactic, onlay dHACM sheets without fixation will reduce IH formation in a high-risk&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Anticipated">May 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 20, 2022</primary_completion_date>
  <phase>Phase 4</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>5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from LSUHSC-NO surgeons' practices .&#xD;
Subjects will be randomized to treatment or control at a rate of 1:1, stratified by surgeon. Subjects, nursing staff, and surgeons not present at the time of fascial closure will be kept blinded to the subjects' treatment arm. Computer-generated randomization will be performed in permutated blocks of 20 patients, using SAS version 9.4.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from 8 LSUHSC-NO surgeons' practices (Drs. Boudreaux, Stuke, Orangio, Moore, tMarr, Hunt, Greiffenstein, and Barton).&#xD;
Subjects will be randomized to treatment or control at a rate of 1:1, stratified by surgeon. Subjects, nursing staff, and surgeons not present at the time of fascial closure will be kept blinded to the subjects' treatment arm. Computer-generated randomization will be performed in permutated blocks of 20 patients, using SAS version 9.4.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac&gt; 4mm diameter</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intraoperative and postoperative complications</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">533</enrollment>
  <condition>Incisional Hernia</condition>
  <arm_group>
    <arm_group_label>Treatment Arm-dHACM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients enrolled in this arm will have routine closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>dHACM (AmnioWrap)</intervention_name>
    <description>Dehydrated human amnion-chorion membrane (dHACM) is a healing adjunct that has been applied in a broad range of disease, and is FDA registered for wound healing.</description>
    <arm_group_label>Treatment Arm-dHACM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient &gt; 18 years&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Non-emergent operation&#xD;
&#xD;
          -  Predicted incisional herna (IH) risk ≥150% of the average IH risk, as calculated by&#xD;
             the University of Pennsylvania Hernia Risk Calculator, which accounts for 18 IH risk&#xD;
             factors&#xD;
&#xD;
          -  BMI &gt; 27 yields IH risk &gt; 150% of the average IH risk; this can be used as a shortcut&#xD;
             for screening potential subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous intraperitoneal mesh placement&#xD;
&#xD;
          -  Previous abdominal incisional hernia&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Patients with inflammatory bowel disease&#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_contact>
    <last_name>Frank Lau, MD</last_name>
    <phone>504-412-1240</phone>
    <email>flau@lsuhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ann D McKendrick, MSW</last_name>
    <phone>504-251-3924</phone>
    <email>amcken@lsuhsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Frank Lau, MD</last_name>
      <phone>504-412-1240</phone>
      <email>flau@lsuhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Ian Hodgdon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Michael Cook, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center in New Orleans</investigator_affiliation>
    <investigator_full_name>Frank Lau, MD</investigator_full_name>
    <investigator_title>Associate Professor of Plastic &amp; Reconstructive Surgery</investigator_title>
  </responsible_party>
  <keyword>amniotic membrane</keyword>
  <keyword>placenta-derived tissue</keyword>
  <keyword>incisional hernia</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/NCT04417140
org study id: LSUHSC-NO IRB # 19-174
nct id: NCT04417140
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Currently, no standard of care exists to prevent incisional hernias (IH). This study will
      compare how frequently IH develop in standard abdominal closures vs. abdominal closures with
      dHACM added. By adding dHACM to the standard closure, we think we can reduce the formation of
      IH.

      If patients decide to participate in this study, they will be randomly assigned to one of two
      study arms, Arm A or Arm B. They will have a 50% chance of being assigned to either arm. The
      assignment will be made by computer program and is completely random. Patients are not
      informed of which arm they are assigned.

      Arm A (Treatment Arm): dHACM Patients enrolled in this arm will have a thin sheet of dHACM
      placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human
      Amniotic-Chorion Membrane. It is a FDA-registered healing adjunct that has been applied in a
      broad range of diseases including wounds, plantar fasciitis and burns.

      Arm B (Control Arm) Patients enrolled in this arm will have standard fascial closure.

      Data collection will be performed at routine follow-up outpatient clinic visits with the
      primary surgeon to assess for IH related symptoms. At 6 months after surgery, patients will
      see a surgeon who is blinded to the randomization. This surgeon will perform a painless
      handheld ultrasound examination of the incision site.
Two million laparotomies are performed annually in the United States (US). Following these
      surgeries, the incidence of new incisional hernias (IH) is estimated at 400,000 cases per
      year. These hernias are a major source of morbidity and mortality for patients, and they
      result in $6-10 billion per year in healthcare costs. Our multidisciplinary hernia prevention
      group has identified a novel IH prevention strategy in the form of dehydrated human
      amniotic-chorionic membrane (dHACM). We previously showed that dHACM prevents IH in animal
      models, and subsequently in a prospective cohort of high-risk patients.

      The purpose of this trial is to quantify the efficacy of dHACM in IH prophylaxis by
      performing a prospective, double-blinded randomized controlled trial. Our specific aim is to
      test the hypothesis that augmentation of standard abdominal fascia closures with
      prophylactic, onlay dHACM sheets without fixation will reduce IH formation in a high-risk
      population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from LSUHSC-NO surgeons' practices .
Subjects will be randomized to treatment or control at a rate of 1:1, stratified by surgeon. Subjects, nursing staff, and surgeons not present at the time of fascial closure will be kept blinded to the subjects' treatment arm. Computer-generated randomization will be performed in permutated blocks of 20 patients, using SAS version 9.4.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: 5.1 General Design Description A double-blinded RCT with two arms: treatment (dHACM) and control. Patients will be recruited from 8 LSUHSC-NO surgeons' practices (Drs. Boudreaux, Stuke, Orangio, Moore, tMarr, Hunt, Greiffenstein, and Barton).
Subjects will be randomized to treatment or control at a rate of 1:1, stratified by surgeon. Subjects, nursing staff, and surgeons not present at the time of fascial closure will be kept blinded to the subjects' treatment arm. Computer-generated randomization will be performed in permutated blocks of 20 patients, using SAS version 9.4.
measure: Incidence of IH as determined by physical exam or abdominal ultrasound demonstrating a midline fascial defect and hernia sac> 4mm diameter
time frame: 6 months
measure: Intraoperative and postoperative complications
time frame: 6 months
arm group label: Treatment Arm-dHACM
arm group type: Experimental
description: Patients enrolled in this arm will have a thin sheet of dHACM placed as an overlay over the length of the closed incisions. dHACM is Dehydrated Human Amniotic-Chorion Membrane. It is a FDA registered healing adjunct that has been applied in a broad range of diseases including wounds, plantar fasciitis and burns.
arm group label: Control Arm
arm group type: No Intervention
description: Patients enrolled in this arm will have routine closure.
intervention type: Biological
intervention name: dHACM (AmnioWrap)
description: Dehydrated human amnion-chorion membrane (dHACM) is a healing adjunct that has been applied in a broad range of disease, and is FDA registered for wound healing.
arm group label: Treatment Arm-dHACM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Lau, MD
phone: 504-412-1240
email: flau@lsuhsc.edu
last name: Ann D McKendrick, MSW
phone: 504-251-3924
email: amcken@lsuhsc.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center in New Orleans
investigator full name: Frank Lau, MD
investigator title: Associate Professor of Plastic & Reconstructive Surgery
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No