<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/NCT04407364</url>
  </required_header>
  <id_info>
    <org_study_id>MPMCOM20</org_study_id>
    <nct_id>NCT04407364</nct_id>
  </id_info>
  <brief_title>MPM Medical CoMatryx Surgical Bovine Collagen Study</brief_title>
  <official_title>The CoMatryx Surgical Collagen Powder is a Soft Tissue Repair Product Made of 100% Type I Bovine Collagen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MPM Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Texas Health Resources</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MPM Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this prospective enrollment study is to collect data confirming safety,&#xD;
      performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum&#xD;
      1-year follow-up and compare it to a historical control group who did not receive the product&#xD;
      at the time of surgery.&#xD;
&#xD;
      The primary objective is to confirm safety and clinical benefits of the product. This will be&#xD;
      assessed by recording the rate of wound healing and incidence and frequency of wound care&#xD;
      related complications. Relationship of complications to the product should be specified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CoMatryx Surgical Collagen powder is a soft tissue repair product made of 100% Type I&#xD;
      Bovine collagen. It is non-hydrolyzed and not cross-linked chemically. It is biocompatible,&#xD;
      biodegradable and free of synthetics. The product does not have any specific storage&#xD;
      requirements.&#xD;
&#xD;
      The CoMatryx Surgical Collagen powder provides a physiologically favorable environment to&#xD;
      promote healing at the wound site. When administered, the powder conforms to the wound site&#xD;
      and forms a gelatinous occlusive barrier. Along with providing 19 amino acids directly to the&#xD;
      wound site it also occludes live nerve endings reducing pain. Treating the wound with the&#xD;
      CoMatryx Surgical Collagen powder provides the non-hydrolyzed collagen wound surface&#xD;
      promoting autolytic debridement. The powder is effective in all phases of wound healing and&#xD;
      can be delivered with antibiotics in areas where there may be a cavity. This product has FDA&#xD;
      510(k) clearance for surgical wounds, full thickness wounds, traumatic wounds and skin tears.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Anticipated">December 2, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CoMatryx Surgical Bovine Collagen</measure>
    <time_frame>This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.</time_frame>
    <description>The primary objective is to confirm safety and performance of the study product. This will be assessed by recording the rate of healing, incidence and frequency of complications and adverse events relative to the surgical incision at 1-week, 2-week, 6-week, 6-month and 1-year follow-up. Height and Weight will be combined as BMI(kg/m^2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CoMatryx Surgical Bovine Collagen Height and Weight</measure>
    <time_frame>This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.</time_frame>
    <description>Height and Weight will be combined as BMI(kg/m^2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bovine Collagen</measure>
    <time_frame>This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.</time_frame>
    <description>The secondary objective is the assessment of clinical benefits by analyzing recorded subject-reported pain scores</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Surgical Wound, Healed</condition>
  <arm_group>
    <arm_group_label>Intervention Cohort</arm_group_label>
    <description>The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical Cohort</arm_group_label>
    <description>Primary and Revision total hip arthroplasty patients between 18-85 years of age</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoMatryx Surgical Bovine Collagen</intervention_name>
    <description>The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen</description>
    <arm_group_label>Historical Cohort</arm_group_label>
    <arm_group_label>Intervention Cohort</arm_group_label>
    <other_name>Interventional Cohort</other_name>
    <other_name>Historical Cohort with no intervention</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary and Revision total hip arthroplasty patients between 18-85 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Subjects must be 18 years of age or older&#xD;
&#xD;
               -  Subject must be willing and able to sign IRB approved informed consent&#xD;
&#xD;
               -  Subject must have a BMI of 35 or higher&#xD;
&#xD;
               -  Surgical approach of only ASI (anterior supine)&#xD;
&#xD;
               -  Primary total hip arthroplasty&#xD;
&#xD;
               -  Revision total hip arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Subjects more than 85 years of age&#xD;
&#xD;
               -  Subjects who will be or have undergone bilateral total hip replacements&#xD;
&#xD;
               -  Subject is known to be pregnant or nursing&#xD;
&#xD;
               -  Subject is an alcohol or drug abuser&#xD;
&#xD;
               -  Subject has a psychiatric illness or cognitive deficit that will not allow for&#xD;
                  proper informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kwame Ennin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Health Physicians Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Scott Miller</last_name>
    <phone>9728934049</phone>
    <email>scott.miller@mpmmed.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shuvie Dasgupta</last_name>
    <phone>9729817114</phone>
    <email>ShuvalaxmiDasgupta@texashealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Texas Center for Joint Replacement</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>shuvie dasgupta</last_name>
      <phone>972-981-7114</phone>
      <email>ShuvalaxmiDasgupta@texashealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</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>Surgical Wound</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/NCT04407364
org study id: MPMCOM20
nct id: NCT04407364
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this prospective enrollment study is to collect data confirming safety,
      performance and clinical benefits of the CoMatryx Surgical Collagen powder at a minimum
      1-year follow-up and compare it to a historical control group who did not receive the product
      at the time of surgery.

      The primary objective is to confirm safety and clinical benefits of the product. This will be
      assessed by recording the rate of wound healing and incidence and frequency of wound care
      related complications. Relationship of complications to the product should be specified.
The CoMatryx Surgical Collagen powder is a soft tissue repair product made of 100% Type I
      Bovine collagen. It is non-hydrolyzed and not cross-linked chemically. It is biocompatible,
      biodegradable and free of synthetics. The product does not have any specific storage
      requirements.

      The CoMatryx Surgical Collagen powder provides a physiologically favorable environment to
      promote healing at the wound site. When administered, the powder conforms to the wound site
      and forms a gelatinous occlusive barrier. Along with providing 19 amino acids directly to the
      wound site it also occludes live nerve endings reducing pain. Treating the wound with the
      CoMatryx Surgical Collagen powder provides the non-hydrolyzed collagen wound surface
      promoting autolytic debridement. The powder is effective in all phases of wound healing and
      can be delivered with antibiotics in areas where there may be a cavity. This product has FDA
      510(k) clearance for surgical wounds, full thickness wounds, traumatic wounds and skin tears.
observational model: Cohort
time perspective: Retrospective
measure: CoMatryx Surgical Bovine Collagen
time frame: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
description: The primary objective is to confirm safety and performance of the study product. This will be assessed by recording the rate of healing, incidence and frequency of complications and adverse events relative to the surgical incision at 1-week, 2-week, 6-week, 6-month and 1-year follow-up. Height and Weight will be combined as BMI(kg/m^2)
measure: CoMatryx Surgical Bovine Collagen Height and Weight
time frame: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
description: Height and Weight will be combined as BMI(kg/m^2)
measure: Bovine Collagen
time frame: This study will require following-up with patients up to 1-year post surgery. The estimated time of completion from enrollment (100 patients) to completing 1 year follow-up is 2 years.
description: The secondary objective is the assessment of clinical benefits by analyzing recorded subject-reported pain scores
arm group label: Intervention Cohort
description: The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
arm group label: Historical Cohort
description: Primary and Revision total hip arthroplasty patients between 18-85 years of age
intervention type: Device
intervention name: CoMatryx Surgical Bovine Collagen
description: The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
arm group label: Historical Cohort
arm group label: Intervention Cohort
other name: Interventional Cohort
other name: Historical Cohort with no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kwame Ennin, MD
role: Principal Investigator
affiliation: Texas Health Physicians Group
last name: Scott Miller
phone: 9728934049
email: scott.miller@mpmmed.com
last name: Shuvie Dasgupta
phone: 9729817114
email: ShuvalaxmiDasgupta@texashealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Surgical Wound
sharing ipd: No