<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/NCT03271164</url>
  </required_header>
  <id_info>
    <org_study_id>CL-K1002-P011</org_study_id>
    <nct_id>NCT03271164</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Efficacy of FBPM10 System in the Treatment of Post-surgical Wounds</brief_title>
  <official_title>Prospective Randomized Controlled Case Series Evaluating the Safety and Efficacy of FBPM10 System When Compared to Standard of Care in the Treatment of Post-surgical Wounds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLOX Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KLOX Technologies Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective randomized controlled case series in patients having a surgery for&#xD;
      bilateral breast reduction. Objectives of the case series are to evaluate the safety and&#xD;
      efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E&#xD;
      cream) in the treatment of post-surgical wounds.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 29, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events, Serious adverse events, device incidents and compliance</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Number of adverse events, serious adverse events, device incidents and missed treatment visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale (POSAS)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Assessment of the efficacy of FBPM10 and standard of care by the patient and by the investigator via the POSAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vancouver Scar Scale (VSS)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of wound management</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Patient's self-assessment of ease of wound management by a specific questionnaire</description>
  </secondary_outcome>
  <other_outcome>
    <measure>External echography</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Assessment of the aspect and depth of the dermal and epidermal superficial subcutaneous tissues in the two treatment groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Post-surgical Wounds</condition>
  <arm_group>
    <arm_group_label>Treatment with FBPM10 system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One breast will be randomized to be treated with FBPM10 System.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment with standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One breast will be selected to be treated with massages with vitamin E cream.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FBPM10 System</intervention_name>
    <description>Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.</description>
    <arm_group_label>Treatment with FBPM10 system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massages with vitamin E cream</intervention_name>
    <description>The other breast will be treated with wound massages with vitamin E cream.</description>
    <arm_group_label>Treatment with standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated written informed consent form;&#xD;
&#xD;
          2. Female 18 years of age and older;&#xD;
&#xD;
          3. Good general health, stable weight, free of systemic diseases such as diabetes,&#xD;
             arthritis, HIV infection or genetic disorder that could influence the outcome of the&#xD;
             treatment;&#xD;
&#xD;
          4. Fitzpatrick skin type I to III;&#xD;
&#xD;
          5. Patients with bilateral breast reduction, expected to have newly formed post-surgery&#xD;
             breast incisions of comparable length and of comparable appearance, located on&#xD;
             comparable skin area;&#xD;
&#xD;
          6. Patients able to understand, willing and able to comply with all study requirements&#xD;
             and post-operative instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to understand the Study and its requirements or to give informed consent;&#xD;
&#xD;
          2. Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that&#xD;
             might interfere with healing within the last three months prior to Treatment&#xD;
             initiation;&#xD;
&#xD;
          3. Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel,&#xD;
             enoxaparin or high doses of aspirin (&gt; 162 mg daily);&#xD;
&#xD;
          4. Female pregnant patient (by medical history or as ascertained by a pregnancy test);&#xD;
&#xD;
          5. Patient with current alcohol use or actively consuming drugs (addiction) as it may&#xD;
             interfere with patient's ability to comply with Study procedures;&#xD;
&#xD;
          6. Patient with known photosensitivity, taking drug(s) to treat photosensitivity, with&#xD;
             concurrent disease (such as porphyria) or drug(s) (such as methotrexate or&#xD;
             chloroquine) known to induce severe photosensitivity of the skin;&#xD;
&#xD;
          7. Patients who are immunocompromised or taking immunosuppressive therapy;&#xD;
&#xD;
          8. Any concurrent therapy that, in the investigator's opinion, would interfere with the&#xD;
             evaluation of the safety or efficacy of the Study investigational device;&#xD;
&#xD;
          9. Patient has ongoing malignant disease of any type, active systemic, local skin&#xD;
             infection or disease, autoimmune disease or any significant chronic disease which, in&#xD;
             the opinion of the investigator, might interfere with the evaluation of the Study&#xD;
             objectives or would result in non-compliance with the Study protocol;&#xD;
&#xD;
         10. Patients having had surgery in the area to be incised within one year of Study&#xD;
             Screening;&#xD;
&#xD;
         11. Patients with tattoos in the areas of incisions;&#xD;
&#xD;
         12. Patients with history or familial history of keloids or hypertrophic scars;&#xD;
&#xD;
         13. Patients with incisions that are actively bleeding;&#xD;
&#xD;
         14. Patients with known skin hypersensitivity;&#xD;
&#xD;
         15. Patients with known allergic reactions to silicone.&#xD;
&#xD;
         16. Patients that cannot start the treatment within 14 days of the surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Victoria Park Medispa</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3Z1C3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</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>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin E</mesh_term>
  </intervention_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/NCT03271164
org study id: CL-K1002-P011
nct id: NCT03271164
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized controlled case series in patients having a surgery for
      bilateral breast reduction. Objectives of the case series are to evaluate the safety and
      efficacy of the FBPM10 System when compared with standard of care (massages with vitamin E
      cream) in the treatment of post-surgical wounds.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events, Serious adverse events, device incidents and compliance
time frame: Up to 24 weeks
description: Number of adverse events, serious adverse events, device incidents and missed treatment visits
measure: Patient and Observer Scar Assessment Scale (POSAS)
time frame: Up to 24 weeks
description: Assessment of the efficacy of FBPM10 and standard of care by the patient and by the investigator via the POSAS
measure: Vancouver Scar Scale (VSS)
time frame: Up to 24 weeks
description: Assessment of the efficacy of FBPM10 and standard of care by the investigator via the VSS
measure: Ease of wound management
time frame: Up to 24 weeks
description: Patient's self-assessment of ease of wound management by a specific questionnaire
measure: External echography
time frame: Up to 24 weeks
description: Assessment of the aspect and depth of the dermal and epidermal superficial subcutaneous tissues in the two treatment groups
arm group label: Treatment with FBPM10 system
arm group type: Experimental
description: One breast will be randomized to be treated with FBPM10 System.
arm group label: Treatment with standard of care
arm group type: Active Comparator
description: One breast will be selected to be treated with massages with vitamin E cream.
intervention type: Device
intervention name: FBPM10 System
description: Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
arm group label: Treatment with FBPM10 system
intervention type: Other
intervention name: Massages with vitamin E cream
description: The other breast will be treated with wound massages with vitamin E cream.
arm group label: Treatment with standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
mesh term: Vitamin E