<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/NCT02997592</url>
  </required_header>
  <id_info>
    <org_study_id>CIP0009</org_study_id>
    <nct_id>NCT02997592</nct_id>
  </id_info>
  <brief_title>Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns</brief_title>
  <acronym>SPINCARE2</acronym>
  <official_title>Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns - A Prospective Single Arm, Safety and Efficacy, Open Labeled Multi-center Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanomedic Technologies Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nicast Ltd.</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>
      Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A&#xD;
      prospective, single arm, safety and efficacy, open labeled multi-center study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SpinCare is an electrospinning portable device intended for the external treatment of&#xD;
      burns and wounds. The SpinCare is the first made on the spot, bed side, and completely&#xD;
      personalized dressing system; with excellent coverage of all size, shapes and difficult&#xD;
      contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates&#xD;
      excellent medium for tissue repair and healing.&#xD;
&#xD;
      The objective of this study is to evaluate the performance, safety and efficacy of the&#xD;
      SpinCare System in the treatment of superficial to intermediate partial thickness burns.&#xD;
&#xD;
      The study included 3 sites. Adult patients with superficial to intermediate partial thickness&#xD;
      burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface&#xD;
      Area); with an independent burn of up to 5% TBSA.&#xD;
&#xD;
      A prospective single arm, safety and efficacy, open labeled, multi-center study for the&#xD;
      treatment of partial thickness burn wounds not considered for surgery using the SpinCare&#xD;
      System.&#xD;
&#xD;
      44 patients enrolled in the study.&#xD;
&#xD;
      Endpoints:&#xD;
&#xD;
        -  Wound healing and re-epithelialization on day 21.&#xD;
&#xD;
        -  The burn will be considered healed when at least 95% of the total area is&#xD;
           re-epithelialized and no scabs exist.&#xD;
&#xD;
             -  Ease of use&#xD;
&#xD;
             -  At postoperative days 7, 14, 21&#xD;
&#xD;
        -  Dermal safety assessed by Draize Score&#xD;
&#xD;
        -  Visual estimate of wound healing and re-epithelialization&#xD;
&#xD;
        -  Pain&#xD;
&#xD;
        -  Infection&#xD;
&#xD;
        -  Itching&#xD;
&#xD;
             -  Itching and scar quality at 3 and 6 months&#xD;
&#xD;
             -  Itching and scar quality at 12 months (optional)&#xD;
&#xD;
             -  Device related adverse events&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">August 16, 2021</completion_date>
  <primary_completion_date type="Actual">March 9, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burn wound healing</measure>
    <time_frame>21 days</time_frame>
    <description>Wound healing and re-epithelialization on day 21. The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dermal safety test (erythema and edema)</measure>
    <time_frame>Every time the SpinCare dressing is delivered up to 21 days after initial dressing</time_frame>
    <description>Dermal safety will be assessed by Draize score including signs of erythema and edema.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain as assessed by VAS</measure>
    <time_frame>21 days</time_frame>
    <description>Pain will be assessed at rest, during dressing application (when applicable) and during dressing removal (when applicable) using VAS (Visual Analog Scale) scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants having an infection at the burn wound.</measure>
    <time_frame>Up to 21 days after initial application of the dressing</time_frame>
    <description>If infection is suspected clinically, a swab will be taken for microbiological examination and the patient will be treated according to the medical center's standard practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of use</measure>
    <time_frame>Every time the SpinCare is used up to 21 days after initial application of the dressing</time_frame>
    <description>ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Partial Thickness Burn</condition>
  <arm_group>
    <arm_group_label>SpinCare</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with partial thickness burns treated with the SpinCare System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpinCare</intervention_name>
    <description>The burn wound is treated using the SpinCare Systen</description>
    <arm_group_label>SpinCare</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old at enrolment. Both genders.&#xD;
&#xD;
          -  The patient has partial thickness burn wounds (second degree superficial to&#xD;
             intermediate) of up to 10% TBSA; of which the target wound for treatment is of up to&#xD;
             5% TBSA or up to 300cm2.&#xD;
&#xD;
          -  Presenting at the emergency room within the first 24-48 hours post-injury.&#xD;
&#xD;
          -  Patient's wound is defined as a partial thickness burn for conservative treatment&#xD;
             (superficial to intermediate second degree).&#xD;
&#xD;
          -  Patient underwent cleansing/debridement of initial burn before applying the dressing&#xD;
&#xD;
          -  The patient is able and willing to comply with study procedures and give written&#xD;
             informed consent prior to enrollment in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any known or suspected systemic infection&#xD;
&#xD;
          -  Any known sensitivity to components/products used in this study&#xD;
&#xD;
          -  Any active, uncontrolled, progressive or untreated malignancy&#xD;
&#xD;
          -  Use of penicillamine, corticosteroid or immunosuppressive medication within two months&#xD;
             prior to enrollment or who is likely to be prescribed these medications or any other&#xD;
             medications known to adversely affect wound healing during study participation&#xD;
&#xD;
          -  Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or&#xD;
             endocrinologic disorders&#xD;
&#xD;
          -  Major dermatological disorders such as: psoriasis, pemphigus, Steven Johnson, etc.&#xD;
&#xD;
          -  Patients with burns larger than 10% TBSA&#xD;
&#xD;
          -  Patients with burns up to 10% TBSA but no target wound of up to 5% TBSA or up to&#xD;
             300cm2&#xD;
&#xD;
          -  Patients suffering from electrical or chemical burns.&#xD;
&#xD;
          -  Patients suffering from frostbites.&#xD;
&#xD;
          -  Patients suffering from burn wounds that are third degree or full thickness.&#xD;
&#xD;
          -  Patients suffering from burn wounds in the head, neck or genital areas&#xD;
&#xD;
          -  Female patients who are pregnant or nursing&#xD;
&#xD;
          -  Psychiatric patient.&#xD;
&#xD;
          -  Soldiers&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to the Screening Visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moti Harats, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burn Unit, Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 12, 2022</last_update_submitted>
  <last_update_submitted_qc>June 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 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>Burns</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/NCT02997592
org study id: CIP0009
nct id: NCT02997592
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the SpinCare™ System in the Treatment of Partial Thickness Burns. A
      prospective, single arm, safety and efficacy, open labeled multi-center study
The SpinCare is an electrospinning portable device intended for the external treatment of
      burns and wounds. The SpinCare is the first made on the spot, bed side, and completely
      personalized dressing system; with excellent coverage of all size, shapes and difficult
      contours. The nano-fibrous dressing mimics the structure of natural body tissue and creates
      excellent medium for tissue repair and healing.

      The objective of this study is to evaluate the performance, safety and efficacy of the
      SpinCare System in the treatment of superficial to intermediate partial thickness burns.

      The study included 3 sites. Adult patients with superficial to intermediate partial thickness
      burns (second degree superficial to intermediate) of up to 10% TBSA (Total Body Surface
      Area); with an independent burn of up to 5% TBSA.

      A prospective single arm, safety and efficacy, open labeled, multi-center study for the
      treatment of partial thickness burn wounds not considered for surgery using the SpinCare
      System.

      44 patients enrolled in the study.

      Endpoints:

        -  Wound healing and re-epithelialization on day 21.

        -  The burn will be considered healed when at least 95% of the total area is
           re-epithelialized and no scabs exist.

             -  Ease of use

             -  At postoperative days 7, 14, 21

        -  Dermal safety assessed by Draize Score

        -  Visual estimate of wound healing and re-epithelialization

        -  Pain

        -  Infection

        -  Itching

             -  Itching and scar quality at 3 and 6 months

             -  Itching and scar quality at 12 months (optional)

             -  Device related adverse events
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Burn wound healing
time frame: 21 days
description: Wound healing and re-epithelialization on day 21. The burn will be considered healed when at least 95% of the total area is re-epithelialized and no scabs exist.
measure: Dermal safety test (erythema and edema)
time frame: Every time the SpinCare dressing is delivered up to 21 days after initial dressing
description: Dermal safety will be assessed by Draize score including signs of erythema and edema.
measure: Pain as assessed by VAS
time frame: 21 days
description: Pain will be assessed at rest, during dressing application (when applicable) and during dressing removal (when applicable) using VAS (Visual Analog Scale) scale.
measure: Number of participants having an infection at the burn wound.
time frame: Up to 21 days after initial application of the dressing
description: If infection is suspected clinically, a swab will be taken for microbiological examination and the patient will be treated according to the medical center's standard practice.
measure: Ease of use
time frame: Every time the SpinCare is used up to 21 days after initial application of the dressing
description: ease of applying and removing the dressing will be evaluated using 0-5 numerical rating scale (NRS).
arm group label: SpinCare
arm group type: Experimental
description: Patients with partial thickness burns treated with the SpinCare System
intervention type: Device
intervention name: SpinCare
description: The burn wound is treated using the SpinCare Systen
arm group label: SpinCare
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moti Harats, Dr
role: Principal Investigator
affiliation: Sheba Medical Center
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Burns
sharing ipd: No