<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/NCT01709240</url>
  </required_header>
  <id_info>
    <org_study_id>BW102</org_study_id>
    <nct_id>NCT01709240</nct_id>
  </id_info>
  <brief_title>Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure</brief_title>
  <official_title>Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IonMed Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IonMed Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and performance of the BioWeld1 System&#xD;
      procedure for surgical incision closure of the skin in women scheduled for elective C-section&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In every surgical procedure, there is a need to close the incision that was made. Current&#xD;
      methods for incision closure include stitching, gluing and stapling. Some of these methods&#xD;
      are time consuming, have potential for infection and may leave a significant scar. The&#xD;
      bioWeld1 technology suggests a new approach for incision closure. It is a novel medical&#xD;
      device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan&#xD;
      film is intended to be applied to the skin incision, while the BioWeld1device is used for&#xD;
      welding the Chitosan to the skin by means of cold plasma technology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Internal decision&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">April 2013</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Safety</measure>
    <time_frame>Within 21 days post procedure</time_frame>
    <description>Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance</measure>
    <time_frame>At 21 days post procedure</time_frame>
    <description>The following secondary variables will be examined:&#xD;
Complete epidermal closure.&#xD;
Redness and edemas grade &lt;1 in at least 87% of the subjects.&#xD;
Encrustation grade &lt;1 in at least 87% of the subjects.&#xD;
Discharge from wound is negative in at least 87% of the subjects.&#xD;
Photographic evidence of clean healing in at least 30% of the cases.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Child Delivery Using an Elective C- Section</condition>
  <arm_group>
    <arm_group_label>BioWeld1 System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioWeld1 System</intervention_name>
    <description>External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.</description>
    <arm_group_label>BioWeld1 System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 20 to 40 years old.&#xD;
&#xD;
          2. Women scheduled for child delivery using an elective C- section.&#xD;
&#xD;
          3. Women in their first or second pregnancy having a C-section for the first time&#xD;
&#xD;
          4. Healthy women with no systemic diseases such as diabetes, heart disease etc.&#xD;
&#xD;
          5. Women with average weight, BMI prior pregnancy of 18.5-25.&#xD;
&#xD;
          6. Women with no skin diseases&#xD;
&#xD;
          7. Subject understands the study requirements and the treatment procedures and provides&#xD;
             written Informed Consent before any study-specific tests or procedures are performed.&#xD;
&#xD;
          8. The subject commits to return for the scheduled post-operative follow-up visits at the&#xD;
             clinic&#xD;
&#xD;
        General Exclusion Criteria:&#xD;
&#xD;
          1. Women intended for any abdominal surgery other than C-section procedure&#xD;
&#xD;
          2. Women intended for C-section procedure for other purpose than child delivery&#xD;
&#xD;
          3. Any prior C-section procedure for any purpose&#xD;
&#xD;
          4. Women Received/Receiving radiotherapy or chemotherapy of any kind.&#xD;
&#xD;
          5. Women receiving steroids or any other medication that interferes with wound healing.&#xD;
&#xD;
          6. Women receiving Acutan in the last half year.&#xD;
&#xD;
          7. Women with bleeding diathesis or hypercoagulable state.&#xD;
&#xD;
          8. Women with prior cosmetic or medical treatment in the target area (e.g.&#xD;
             phosphatydilcholine injections).&#xD;
&#xD;
          9. Women suffering from Thrombocytopenia (platelets count&lt;100,000/mm3) pre-procedure.&#xD;
&#xD;
         10. Women who is currently participating or have participated in an investigational study,&#xD;
             other than this study, within the past 60 days.&#xD;
&#xD;
         11. Psychiatric background.&#xD;
&#xD;
        Intra operative exclusion criteria:&#xD;
&#xD;
          1. Severe excessive bleeding from the wound&#xD;
&#xD;
          2. Patient is not eligible for an experimental closure according to the physician&#xD;
             discretion.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Drorit Hochner-Celnikier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah University Hospital, Mount Scopus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hadassah University Hospital, Mount Scopus</name>
      <address>
        <city>Jerusalem</city>
        <zip>91240</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chitosan</keyword>
  <keyword>Plasma</keyword>
  <keyword>Incision Closure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</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/NCT01709240
org study id: BW102
nct id: NCT01709240
lead sponsor: 
has dmc: No
The purpose of this study is to assess the safety and performance of the BioWeld1 System
      procedure for surgical incision closure of the skin in women scheduled for elective C-section
      procedure.
In every surgical procedure, there is a need to close the incision that was made. Current
      methods for incision closure include stitching, gluing and stapling. Some of these methods
      are time consuming, have potential for infection and may leave a significant scar. The
      bioWeld1 technology suggests a new approach for incision closure. It is a novel medical
      device that consists of a Chitosan film and the BioWeld1 plasma ejecting device. The Chitosan
      film is intended to be applied to the skin incision, while the BioWeld1device is used for
      welding the Chitosan to the skin by means of cold plasma technology.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: Within 21 days post procedure
description: Frequency and severity of incision closure procedure-related adverse events (burns, wound dehiscence or need for additional surgical procedure of the skin wound).
measure: Performance
time frame: At 21 days post procedure
description: The following secondary variables will be examined:
Complete epidermal closure.
Redness and edemas grade <1 in at least 87% of the subjects.
Encrustation grade <1 in at least 87% of the subjects.
Discharge from wound is negative in at least 87% of the subjects.
Photographic evidence of clean healing in at least 30% of the cases.
arm group label: BioWeld1 System
arm group type: Experimental
intervention type: Device
intervention name: BioWeld1 System
description: External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
arm group label: BioWeld1 System
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Drorit Hochner-Celnikier, MD
role: Principal Investigator
affiliation: Hadassah University Hospital, Mount Scopus
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Surgical Wound