<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/NCT02228889</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0041</org_study_id>
    <nct_id>NCT02228889</nct_id>
  </id_info>
  <brief_title>RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction</brief_title>
  <official_title>Prospective Trial Comparing the Performance Profiles of Two Non-Cross-Linked Porcine Dermal Matrices in Abdominal Wall Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeffrey Janis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare the clinical outcomes of two commonly used,&#xD;
      FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice&#xD;
      and XenMatrix). The two meshes are derived from pig skin from which cells have been removed&#xD;
      and which have been sterilized. The two meshes are made by two different companies using&#xD;
      different processes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized-controlled trial comparing two porcine acellular matrices&#xD;
      in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of&#xD;
      mesh used while surgeons are not).&#xD;
&#xD;
      Our goals in this study are:&#xD;
&#xD;
        1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked&#xD;
           porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively&#xD;
&#xD;
        2. SECONDARY OUTCOMES&#xD;
&#xD;
      i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in&#xD;
      abdominal wall reconstruction at 30 days and 1 year postoperatively&#xD;
&#xD;
        1. Infection&#xD;
&#xD;
        2. Seroma&#xD;
&#xD;
        3. Hematoma&#xD;
&#xD;
        4. Wound dehiscence&#xD;
&#xD;
        5. Skin necrosis&#xD;
&#xD;
        6. Formation of enterocutaneous fistula&#xD;
&#xD;
        7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice&#xD;
           at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix&#xD;
           and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient&#xD;
           pain, physical functioning and quality of life after hernia repair between XenMatrix and&#xD;
           Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient&#xD;
           Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS&#xD;
           Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C.&#xD;
           Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Abdominal wall reconstruction using Strattice</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall complication rate at 1 year</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Surgical Site Occurrences (SSOs) at 1 year</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:&#xD;
Infection&#xD;
Seroma&#xD;
Hematoma&#xD;
Wound dehiscence&#xD;
Skin necrosis&#xD;
Formation of enterocutaneous fistula&#xD;
Mesh infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hernia recurrence rate at 30 days</measure>
    <time_frame>30 days postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bulge rate at 30 days</measure>
    <time_frame>30 days postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall complication rate at 30 days</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Surgical Site Occurrences (SSOs) at 30 days</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include:&#xD;
Infection&#xD;
Seroma&#xD;
Hematoma&#xD;
Wound dehiscence&#xD;
Skin necrosis&#xD;
Formation of enterocutaneous fistula&#xD;
Mesh infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hernia recurrence rate at 1 year</measure>
    <time_frame>1 year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bulge rate at 1 year</measure>
    <time_frame>1 year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity preoperatively</measure>
    <time_frame>At the last office visit before surgery (average of 1-3 weeks before surgery)</time_frame>
    <description>Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference preoperatively</measure>
    <time_frame>At the last office visit before surgery (average of 1-3 weeks before surgery)</time_frame>
    <description>Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity postoperatively</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain interference postoperatively</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning preoperatively</measure>
    <time_frame>At the last office visit before surgery (average of 1-3 weeks before surgery)</time_frame>
    <description>Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical functioning postoperatively</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life preoperatively</measure>
    <time_frame>At the last office visit before surgery (average of 1-3 weeks before surgery)</time_frame>
    <description>Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life postoperatively</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Hernia, Ventral</condition>
  <condition>Intestinal Fistula</condition>
  <condition>Fibromatosis, Abdominal</condition>
  <arm_group>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XenMatrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abdominal wall reconstruction with Strattice</intervention_name>
    <description>Abdominal wall reconstruction using Strattice</description>
    <arm_group_label>Strattice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess pain intensity at last office visit preoperatively</intervention_name>
    <description>Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess pain interference at last office visit preoperatively</intervention_name>
    <description>Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess physical functioning at last office visit preoperatively</intervention_name>
    <description>Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess patient quality of life at last office visit preoperatively</intervention_name>
    <description>Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess patient pain intensity postoperatively</intervention_name>
    <description>Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess pain interference postoperatively</intervention_name>
    <description>Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess physical functioning postoperatively</intervention_name>
    <description>Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess quality of life postoperatively</intervention_name>
    <description>Assess quality of life at 1 year postoperatively using the HerQLes survey</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess hernia recurrence at 30 days postoperatively</intervention_name>
    <description>Assess hernia recurrence at 30 days</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess bulge at 30 days postoperatively</intervention_name>
    <description>Assess bulge at 30 days</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess Surgical Site Occurrences at 30 days postoperatively</intervention_name>
    <description>Assess Surgical Site Occurrences at 30 days</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess hernia recurrence at 1 year postoperatively</intervention_name>
    <description>Assess hernia recurrence at 1 year postoperatively</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess bulge at 1 year postoperatively</intervention_name>
    <description>Assess bulge at 1 year postoperatively</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess Surgical Site Occurrences at 1 year postoperatively</intervention_name>
    <description>Assess Surgical Site Occurrences at 1 year postoperatively</description>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess overall complications at 30 days postoperatively</intervention_name>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assess overall complications at 1 year postoperatively</intervention_name>
    <arm_group_label>Strattice</arm_group_label>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Abdominal wall reconstruction with XenMatrix</intervention_name>
    <description>Abdominal wall reconstruction with XenMatrix</description>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Strattice</intervention_name>
    <description>Strattice mesh</description>
    <arm_group_label>Strattice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XenMatrix</intervention_name>
    <description>Xenmatrix mesh</description>
    <arm_group_label>XenMatrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Patients presenting for elective hernia repair, with Ventral Hernia Working Group&#xD;
             (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia&#xD;
             size, discomfort, risk of bowel incarceration, effect on physical function), and who&#xD;
             have comorbidities or contamination making the use of synthetic mesh contraindicated)&#xD;
&#xD;
          -  Patients deemed to be good surgical candidates, with no active life-threatening&#xD;
             cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who&#xD;
             can have a major surgical procedure without an exceedingly high risk of medical&#xD;
             complications such as pulmonary edema, myocardial infarction, pulmonary embolism,&#xD;
             renal failure, life-threatening bleeding, stroke).&#xD;
&#xD;
          -  Patients presenting for resection of large abdominal wall tumors who are expected to&#xD;
             undergo have tumor extirpative defect that would require biologic mesh for closure&#xD;
             (patients with a large tumor of the abdominal wall who will have a large defect in&#xD;
             their fascia after resection, who need biologic mesh for reinforcement).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to porcine products&#xD;
&#xD;
          -  Active smokers (within the past 4 weeks) presenting for elective hernia repair&#xD;
&#xD;
          -  Patients with active life-threatening cardiac disease, pulmonary disease, renal&#xD;
             disease, hematologic disease presenting for elective hernia repair&#xD;
&#xD;
          -  Patients presenting for emergent hernia repair (in the setting of bowel strangulation,&#xD;
             necrosis, penetrating trauma) as it will be difficult to consent those patients for&#xD;
             the study preoperatively&#xD;
&#xD;
          -  Patients with severe systemic sepsis&#xD;
&#xD;
          -  Patients with frank purulence in the wound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey E Janis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ibrahim Z Khansa, MD</last_name>
    <phone>614-293-9030</phone>
    <email>ibrahim.khansa@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeffrey E Janis, MD</last_name>
    <phone>614-366-1704</phone>
    <email>jeffrey.janis@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jeffrey E Janis, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ibrahim Z Khansa, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Daniel S Eiferman, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vimal Narula, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 21, 2022</last_update_submitted>
  <last_update_submitted_qc>September 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jeffrey Janis</investigator_full_name>
    <investigator_title>Professor of Plastic Surgery, Vice-Chairman</investigator_title>
  </responsible_party>
  <keyword>Hernia</keyword>
  <keyword>Abdominal wall reconstruction</keyword>
  <keyword>Abdominal wall defect</keyword>
  <keyword>Porcine mesh</keyword>
  <keyword>Component separation</keyword>
  <keyword>Abdominal wall tumor</keyword>
  <keyword>Desmoid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibroma</mesh_term>
    <mesh_term>Fibromatosis, Abdominal</mesh_term>
    <mesh_term>Intestinal Fistula</mesh_term>
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Fistula</mesh_term>
    <mesh_term>Hernia, Ventral</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/NCT02228889
org study id: 2014H0041
nct id: NCT02228889
lead sponsor: 
has dmc: No
The purpose of the study is to compare the clinical outcomes of two commonly used,
      FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice
      and XenMatrix). The two meshes are derived from pig skin from which cells have been removed
      and which have been sterilized. The two meshes are made by two different companies using
      different processes.
This is a prospective, randomized-controlled trial comparing two porcine acellular matrices
      in abdominal wall reconstruction. It is single-blind (patients are blinded to the type of
      mesh used while surgeons are not).

      Our goals in this study are:

        1. PRIMARY OUTCOME: To compare the overall complication rates between two non-cross-linked
           porcine dermal matrices (XenMatrix and Strattice) at 30 days and 1 year postoperatively

        2. SECONDARY OUTCOMES

      i. To compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in
      abdominal wall reconstruction at 30 days and 1 year postoperatively

        1. Infection

        2. Seroma

        3. Hematoma

        4. Wound dehiscence

        5. Skin necrosis

        6. Formation of enterocutaneous fistula

        7. Mesh infection ii. To compare the hernia recurrence rate between XenMatrix and Strattice
           at 30 days and 1 year postoperatively iii. To compare the bulge rate between XenMatrix
           and Strattice at 30 days and 1 year postoperatively iv. To compare to changes in patient
           pain, physical functioning and quality of life after hernia repair between XenMatrix and
           Strattice, preoperatively, and at 1 year postoperatively A. Pain assessment: Patient
           Reported Outcomes Measurement Information System (PROMIS) Pain Intensity survey, PROMIS
           Pain Interference survey B. Physical functioning assessment: PROMIS Physical Function C.
           Quality of life assessment: Hernia-Related Quality-of-Life (HerQLes) survey
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Abdominal wall reconstruction using Strattice
primary purpose: Treatment
masking: Single (Participant)
measure: Overall complication rate at 1 year
time frame: 1 year postoperatively
description: Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 1 year postoperatively
measure: Rate of Surgical Site Occurrences (SSOs) at 1 year
time frame: 1 year postoperatively
description: Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 1 year postoperatively. These include:
Infection
Seroma
Hematoma
Wound dehiscence
Skin necrosis
Formation of enterocutaneous fistula
Mesh infection
measure: Hernia recurrence rate at 30 days
time frame: 30 days postoperatively
measure: Bulge rate at 30 days
time frame: 30 days postoperatively
measure: Overall complication rate at 30 days
time frame: 30 days postoperatively
description: Compare the overall complication rates between two non-cross-linked porcine dermal matrices (XenMatrix and Strattice) at 30 days postoperatively
measure: Rate of Surgical Site Occurrences (SSOs) at 30 days
time frame: 30 days postoperatively
description: Compare the rate of Surgical Site Occurrences (SSOs) between XenMatrix and Strattice in abdominal wall reconstruction at 30 days postoperatively. These include:
Infection
Seroma
Hematoma
Wound dehiscence
Skin necrosis
Formation of enterocutaneous fistula
Mesh infection
measure: Hernia recurrence rate at 1 year
time frame: 1 year postoperatively
measure: Bulge rate at 1 year
time frame: 1 year postoperatively
measure: Pain intensity preoperatively
time frame: At the last office visit before surgery (average of 1-3 weeks before surgery)
description: Measure patient pain intensity of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Intensity survey
measure: Pain interference preoperatively
time frame: At the last office visit before surgery (average of 1-3 weeks before surgery)
description: Measure patient pain interference of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Pain Interference survey
measure: Pain intensity postoperatively
time frame: 1 year postoperatively
description: Measure patient pain intensity of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Intensity survey
measure: Pain interference postoperatively
time frame: 1 year postoperatively
description: Measure patient pain interference of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Pain Interference survey
measure: Physical functioning preoperatively
time frame: At the last office visit before surgery (average of 1-3 weeks before surgery)
description: Measure physical functioning of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the PROMIS Physical Function survey
measure: Physical functioning postoperatively
time frame: 1 year postoperatively
description: Measure physical functioning of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the PROMIS Physical Function survey
measure: Quality of life preoperatively
time frame: At the last office visit before surgery (average of 1-3 weeks before surgery)
description: Measure patient quality of life of the two groups (XenMatrix and Strattice), at the last office visit before surgery (average of 1-3 weeks before surgery), using the HerQLes survey (Hernia Related Quality of Life survey)
measure: Quality of life postoperatively
time frame: 1 year postoperatively
description: Measure patient quality of life of the two groups (XenMatrix and Strattice), at 1 year postoperatively, using the HerQLes survey (Hernia Related Quality of Life survey)
arm group label: Strattice
arm group type: Experimental
description: Abdominal wall reconstruction with Strattice Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
arm group label: XenMatrix
arm group type: Experimental
description: Abdominal wall reconstruction with XenMatrix Assess pain intensity at last office visit preoperatively Assess pain interference at last office visit preoperatively Assess physical functioning at last office visit preoperatively Assess patient quality of life at last office visit preoperatively Assess patient pain intensity postoperatively Assess pain interference postoperatively Assess physical functioning postoperatively Assess quality of life postoperatively Assess hernia recurrence at 30 days postoperatively Assess bulge at 30 days postoperatively Assess Surgical Site Occurrences at 30 days postoperatively Assess hernia recurrence at 1 year postoperatively Assess bulge at 1 year postoperatively Assess Surgical Site Occurrences at 1 year postoperatively Assess overall complications at 30 days postoperatively Assess overall complications at 1 year postoperatively
intervention type: Procedure
intervention name: Abdominal wall reconstruction with Strattice
description: Abdominal wall reconstruction using Strattice
arm group label: Strattice
intervention type: Other
intervention name: Assess pain intensity at last office visit preoperatively
description: Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess pain interference at last office visit preoperatively
description: Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess physical functioning at last office visit preoperatively
description: Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess patient quality of life at last office visit preoperatively
description: Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess patient pain intensity postoperatively
description: Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess pain interference postoperatively
description: Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess physical functioning postoperatively
description: Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess quality of life postoperatively
description: Assess quality of life at 1 year postoperatively using the HerQLes survey
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess hernia recurrence at 30 days postoperatively
description: Assess hernia recurrence at 30 days
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess bulge at 30 days postoperatively
description: Assess bulge at 30 days
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess Surgical Site Occurrences at 30 days postoperatively
description: Assess Surgical Site Occurrences at 30 days
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess hernia recurrence at 1 year postoperatively
description: Assess hernia recurrence at 1 year postoperatively
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess bulge at 1 year postoperatively
description: Assess bulge at 1 year postoperatively
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess Surgical Site Occurrences at 1 year postoperatively
description: Assess Surgical Site Occurrences at 1 year postoperatively
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess overall complications at 30 days postoperatively
arm group label: Strattice
arm group label: XenMatrix
intervention type: Other
intervention name: Assess overall complications at 1 year postoperatively
arm group label: Strattice
arm group label: XenMatrix
intervention type: Procedure
intervention name: Abdominal wall reconstruction with XenMatrix
description: Abdominal wall reconstruction with XenMatrix
arm group label: XenMatrix
intervention type: Device
intervention name: Strattice
description: Strattice mesh
arm group label: Strattice
intervention type: Device
intervention name: XenMatrix
description: Xenmatrix mesh
arm group label: XenMatrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Jeffrey E Janis, MD
role: Principal Investigator
affiliation: Ohio State University
last name: Ibrahim Z Khansa, MD
phone: 614-293-9030
email: ibrahim.khansa@gmail.com
last name: Jeffrey E Janis, MD
phone: 614-366-1704
email: jeffrey.janis@osumc.edu
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Jeffrey Janis
investigator title: Professor of Plastic Surgery, Vice-Chairman
mesh term: Fibroma
mesh term: Fibromatosis, Abdominal
mesh term: Intestinal Fistula
mesh term: Hernia
mesh term: Fistula
mesh term: Hernia, Ventral