<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/NCT03830515</url>
  </required_header>
  <id_info>
    <org_study_id>KTM005</org_study_id>
    <nct_id>NCT03830515</nct_id>
  </id_info>
  <brief_title>Evaluation of microMend Device to Close Lacerations</brief_title>
  <official_title>Evaluation of microMend Device to Close Skin Wounds Associated With Repair of Lacerations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KitoTech Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KitoTech Medical, Inc.</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, total of 20 subjects will have lacerations will be closed with microMend,&#xD;
      which is an FDA-listed wound closure product. microMend is a wound closure device that is the&#xD;
      size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive&#xD;
      backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10,&#xD;
      and 3 months using a combination of questionnaires and photographs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-arm Phase 2 Study to evaluate closure of skin wounds associated&#xD;
      with laceration repair using microMend devices. A maximum of 20 Subjects will be enrolled in&#xD;
      the Study in order to have 15 Subjects with evaluations at Month 3 after wound closure. The&#xD;
      primary intent is to assess the wound closure results with microMend closure at Month 3 after&#xD;
      the wound closure procedure. Evaluations will also take place at Days 0 and 10 and 1 Month&#xD;
      post-procedure to assess wound closure results. An Independent Plastic Surgeon who is not&#xD;
      closing wounds in the study will assess the efficacy of wound closure at Day 10, Month 1, and&#xD;
      Month 3. Assessment will also be made of the Subject's pain with applying microMend, time of&#xD;
      wound closure, and opinions of the Providers and Subjects about microMend.&#xD;
&#xD;
      Screening data will be reviewed to determine Subject eligibility. Subjects who meet all&#xD;
      inclusion criteria and none of the exclusion criteria will be entered into the Study. The&#xD;
      Provider may elect to close additional wounds in subjects who have more than one wound that&#xD;
      qualifies for the study.&#xD;
&#xD;
      In the Study, eligible Subjects will undergo the laceration repair procedure as is standard&#xD;
      and customary for each Provider except for skin closure will be performed using microMend&#xD;
      devices. If more than one device is needed, the devices are to be applied adjacent to one&#xD;
      another along the entire length of the wound. microMend devices are to be applied immediately&#xD;
      adjacent to one another with no more than 1 mm separating each adjacent device. (Note: Each&#xD;
      device closes 1-1.5 cm of wound length.). In addition, devices should be applied such that&#xD;
      they extend to or beyond the ends of the wound along its length.&#xD;
&#xD;
      A minimum of two (2) photographs will be taken of each wound both before and after the&#xD;
      application of microMend devices on the day of the wound closure procedure (Day 0).&#xD;
&#xD;
      If a wound is under high tension and/or has a maximum gap of more than 1 cm between the wound&#xD;
      edges, it should be closed with subcutaneous sutures before applying microMend devices. If&#xD;
      this is not performed, the wound should not be closed with microMend and the Subject is not&#xD;
      eligible for the study.&#xD;
&#xD;
      Standard surgical staples, sutures, tissue adhesives, SteriStrips or other bandages should&#xD;
      not be used to close any portion of skin wounds closed with microMend devices.&#xD;
&#xD;
      Each wound should be free of significant tissue injury and bleeding, contain no foreign&#xD;
      bodies, and should be clean and completely dry and free of hair before application of&#xD;
      microMend.&#xD;
&#xD;
      No other wound closure products, such as tissue adhesives, bandages such as SteriStrips,&#xD;
      staples, or sutures should be applied to the wound.&#xD;
&#xD;
      Solutions, ointments, creams, and other moist materials should be avoided during the time&#xD;
      period when the microMend remains on the skin except those recommended by the Provider.&#xD;
&#xD;
      After application of the microMend devices, it is recommended that each wound be covered with&#xD;
      a non-stick gauze dressing. (Note: contact of adhesive with microMend devices is strictly&#xD;
      prohibited.) Subject contact with the wound site should be minimized after placement of the&#xD;
      microMend devices and the dressing. All other activities associated with the laceration&#xD;
      repair procedure should follow the standard procedure used by the Provider. The Provider will&#xD;
      fill out a questionnaire about the wound closure procedure. The Subject will rate the level&#xD;
      of pain associated with microMend application.&#xD;
&#xD;
      The microMend devices are to be removed at the return clinic visit on Day 10 (acceptable&#xD;
      range: Days 7-12) by the Provider (Physician, Nurse Practitioner, Physician's Assistant, or&#xD;
      other qualified health care provider). Photographs are to be obtained of each wound both&#xD;
      before and after removal of all microMend devices. A minimum of two (2) photographs will be&#xD;
      taken of each wound both before and after removal of microMend devices. The Subject will fill&#xD;
      out a questionnaire providing an opinion of microMend.&#xD;
&#xD;
      Each Subject is to return to the clinic at one (1) month post-procedure (acceptable range:&#xD;
      Days 25-40) to obtain photographs of each wound. A minimum of two (2) photographs will be&#xD;
      taken at the 1-month clinic visit. Each Subject is to return to the clinic at three (3)&#xD;
      months after wound closure (acceptable range: 11-15 weeks) to obtain photographs of each&#xD;
      wound. A minimum of two (2) photographs will be taken at the 1-month clinic visit.&#xD;
&#xD;
      Photographs obtained on Day 0, Day 10, Month 1, and Month 3 will be assessed for wound&#xD;
      closure results by an Independent Plastic Surgeon, who is not performing laceration repair or&#xD;
      wound closure in the study. The wound closure will be rated as either Satisfactory or&#xD;
      Unsatisfactory. The quality of the wound closure will further be rated as Excellent, Good,&#xD;
      Fair, or Poor. For Subjects that have had more than one wound closed with microMend devices,&#xD;
      each wound is to be assessed separately at Day 0, Day 10, Month 1, and Month 3.&#xD;
&#xD;
      Total duration of Subject participation will be approximately 4 months, including screening,&#xD;
      treatment, and follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 20, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A single arm open label study testing the ability of microMend to close lacerations.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound closure results of skin wounds after healing</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of photographs of wounds closed with microMend at Monthg 3 by independent physician with experience in assessing skin wounds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall assessment of microMend by Provider at end of the wound closure procedure.</measure>
    <time_frame>Day 0</time_frame>
    <description>Questionnaire on opinion of Provider (Physician, PA, or Nurse Practitioner on usability and other characteristics of microMend</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of wound closure.</measure>
    <time_frame>ay 0</time_frame>
    <description>Measurement of time in seconds to close wound with microMend devices.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject's assessment of microMend.</measure>
    <time_frame>Day 0</time_frame>
    <description>Measurement of pain upon placement of microMend using VAS scoring system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subject's assessment of pain with application of microMend</measure>
    <time_frame>Day 10</time_frame>
    <description>Questionnaire regarding evaluation of microMend</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Lacerations</condition>
  <condition>Wounds</condition>
  <arm_group>
    <arm_group_label>Closure of lacerations with microMend</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laceration closure with microMend</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>microMend</intervention_name>
    <description>Wound closure product consisting of tan array of tiny metal Microstaples affixed to adhesive backing. The device is the size and shape of a butterfly closure and intended for closure of skin wounds.</description>
    <arm_group_label>Closure of lacerations with microMend</arm_group_label>
    <other_name>microMend Skin Closure Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects undergoing a laceration repair that would require sutures, staples, or tissue&#xD;
             adhesives to close the skin wound&#xD;
&#xD;
          -  Age equal to or greater than 18 years old&#xD;
&#xD;
          -  Written informed consent obtained from Subject or Subject's legal representative and&#xD;
             ability for Subject to comply with the requirements of the Study&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Wound on face&#xD;
&#xD;
          -  Wound on flexor surfaces such as over joints&#xD;
&#xD;
          -  Wound on digits (fingers or toes)&#xD;
&#xD;
          -  Wound under high tension, which is not closed with subcutaneous sutures before&#xD;
             application of microMend devices&#xD;
&#xD;
          -  Wound that has a gap of more than 1 cm between the wound edges immediately prior to&#xD;
             application of microMend devices&#xD;
&#xD;
          -  Wound with jagged or irregular edges&#xD;
&#xD;
          -  Wound with significant tissue injury&#xD;
&#xD;
          -  Visual evidence of active infection, contaminated or devitalized tissue, or rash at&#xD;
             laceration location&#xD;
&#xD;
          -  Wound that contain a foreign body&#xD;
&#xD;
          -  Wound site that contains tattoo or other identifiable features&#xD;
&#xD;
          -  Subject with keloid(s)&#xD;
&#xD;
          -  Medical disorder that, in the opinion of the Provider, could have a significant effect&#xD;
             on wound healing&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability of Subject to carry out Subject instructions&#xD;
&#xD;
          -  Subject lacks the capacity to consent&#xD;
&#xD;
          -  Medication that, in the opinion of the Provider, could have a significant effect on&#xD;
             wound healing&#xD;
&#xD;
          -  Skin disorder, such as psoriasis, or current dermatitis or eczema at wound site&#xD;
&#xD;
          -  History of keloids or scar hypertrophy&#xD;
&#xD;
          -  Known bleeding diathesis&#xD;
&#xD;
          -  Sensitivity or allergy to adhesives or medical tape&#xD;
&#xD;
          -  Active infection in any part of the body&#xD;
&#xD;
          -  Use of sutures or staples in addition to microMend to close the outermost skin layer&#xD;
&#xD;
          -  Use of tissue adhesive or other adhesives directly over the wound&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesca Beaudoin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine, Walpert School of Medicine, Brown University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Jay, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine, Walpert School of Medicine, Brown University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ronald Berenson, MD</last_name>
    <phone>206-790-1094</phone>
    <email>rberenson@kitotechmedical.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesca Beaudoin, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2019</study_first_submitted>
  <study_first_submitted_qc>February 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lacerations</keyword>
  <keyword>Wounds</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</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/NCT03830515
org study id: KTM005
nct id: NCT03830515
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
In this study, total of 20 subjects will have lacerations will be closed with microMend,
      which is an FDA-listed wound closure product. microMend is a wound closure device that is the
      size and shape of a butterfly bandage and incorporates tiny Microstaples into an adhesive
      backing. Assessments by practitioners and Subjects of microMend will be made at Days 0 10,
      and 3 months using a combination of questionnaires and photographs.
This is an open-label, single-arm Phase 2 Study to evaluate closure of skin wounds associated
      with laceration repair using microMend devices. A maximum of 20 Subjects will be enrolled in
      the Study in order to have 15 Subjects with evaluations at Month 3 after wound closure. The
      primary intent is to assess the wound closure results with microMend closure at Month 3 after
      the wound closure procedure. Evaluations will also take place at Days 0 and 10 and 1 Month
      post-procedure to assess wound closure results. An Independent Plastic Surgeon who is not
      closing wounds in the study will assess the efficacy of wound closure at Day 10, Month 1, and
      Month 3. Assessment will also be made of the Subject's pain with applying microMend, time of
      wound closure, and opinions of the Providers and Subjects about microMend.

      Screening data will be reviewed to determine Subject eligibility. Subjects who meet all
      inclusion criteria and none of the exclusion criteria will be entered into the Study. The
      Provider may elect to close additional wounds in subjects who have more than one wound that
      qualifies for the study.

      In the Study, eligible Subjects will undergo the laceration repair procedure as is standard
      and customary for each Provider except for skin closure will be performed using microMend
      devices. If more than one device is needed, the devices are to be applied adjacent to one
      another along the entire length of the wound. microMend devices are to be applied immediately
      adjacent to one another with no more than 1 mm separating each adjacent device. (Note: Each
      device closes 1-1.5 cm of wound length.). In addition, devices should be applied such that
      they extend to or beyond the ends of the wound along its length.

      A minimum of two (2) photographs will be taken of each wound both before and after the
      application of microMend devices on the day of the wound closure procedure (Day 0).

      If a wound is under high tension and/or has a maximum gap of more than 1 cm between the wound
      edges, it should be closed with subcutaneous sutures before applying microMend devices. If
      this is not performed, the wound should not be closed with microMend and the Subject is not
      eligible for the study.

      Standard surgical staples, sutures, tissue adhesives, SteriStrips or other bandages should
      not be used to close any portion of skin wounds closed with microMend devices.

      Each wound should be free of significant tissue injury and bleeding, contain no foreign
      bodies, and should be clean and completely dry and free of hair before application of
      microMend.

      No other wound closure products, such as tissue adhesives, bandages such as SteriStrips,
      staples, or sutures should be applied to the wound.

      Solutions, ointments, creams, and other moist materials should be avoided during the time
      period when the microMend remains on the skin except those recommended by the Provider.

      After application of the microMend devices, it is recommended that each wound be covered with
      a non-stick gauze dressing. (Note: contact of adhesive with microMend devices is strictly
      prohibited.) Subject contact with the wound site should be minimized after placement of the
      microMend devices and the dressing. All other activities associated with the laceration
      repair procedure should follow the standard procedure used by the Provider. The Provider will
      fill out a questionnaire about the wound closure procedure. The Subject will rate the level
      of pain associated with microMend application.

      The microMend devices are to be removed at the return clinic visit on Day 10 (acceptable
      range: Days 7-12) by the Provider (Physician, Nurse Practitioner, Physician's Assistant, or
      other qualified health care provider). Photographs are to be obtained of each wound both
      before and after removal of all microMend devices. A minimum of two (2) photographs will be
      taken of each wound both before and after removal of microMend devices. The Subject will fill
      out a questionnaire providing an opinion of microMend.

      Each Subject is to return to the clinic at one (1) month post-procedure (acceptable range:
      Days 25-40) to obtain photographs of each wound. A minimum of two (2) photographs will be
      taken at the 1-month clinic visit. Each Subject is to return to the clinic at three (3)
      months after wound closure (acceptable range: 11-15 weeks) to obtain photographs of each
      wound. A minimum of two (2) photographs will be taken at the 1-month clinic visit.

      Photographs obtained on Day 0, Day 10, Month 1, and Month 3 will be assessed for wound
      closure results by an Independent Plastic Surgeon, who is not performing laceration repair or
      wound closure in the study. The wound closure will be rated as either Satisfactory or
      Unsatisfactory. The quality of the wound closure will further be rated as Excellent, Good,
      Fair, or Poor. For Subjects that have had more than one wound closed with microMend devices,
      each wound is to be assessed separately at Day 0, Day 10, Month 1, and Month 3.

      Total duration of Subject participation will be approximately 4 months, including screening,
      treatment, and follow-up.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single arm open label study testing the ability of microMend to close lacerations.
primary purpose: Treatment
masking: None (Open Label)
measure: Wound closure results of skin wounds after healing
time frame: 3 months
description: Assessment of photographs of wounds closed with microMend at Monthg 3 by independent physician with experience in assessing skin wounds.
measure: Overall assessment of microMend by Provider at end of the wound closure procedure.
time frame: Day 0
description: Questionnaire on opinion of Provider (Physician, PA, or Nurse Practitioner on usability and other characteristics of microMend
measure: Time of wound closure.
time frame: ay 0
description: Measurement of time in seconds to close wound with microMend devices.
measure: Subject's assessment of microMend.
time frame: Day 0
description: Measurement of pain upon placement of microMend using VAS scoring system
measure: Subject's assessment of pain with application of microMend
time frame: Day 10
description: Questionnaire regarding evaluation of microMend
arm group label: Closure of lacerations with microMend
arm group type: Experimental
description: Laceration closure with microMend
intervention type: Device
intervention name: microMend
description: Wound closure product consisting of tan array of tiny metal Microstaples affixed to adhesive backing. The device is the size and shape of a butterfly closure and intended for closure of skin wounds.
arm group label: Closure of lacerations with microMend
other name: microMend Skin Closure Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Francesca Beaudoin, MD, PhD
role: Principal Investigator
affiliation: Department of Emergency Medicine, Walpert School of Medicine, Brown University
last name: Gregory Jay, MD, PhD
role: Principal Investigator
affiliation: Department of Emergency Medicine, Walpert School of Medicine, Brown University
last name: Ronald Berenson, MD
phone: 206-790-1094
email: rberenson@kitotechmedical.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Lacerations
sharing ipd: No