<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/NCT01706848</url>
  </required_header>
  <id_info>
    <org_study_id>HAL-0297</org_study_id>
    <nct_id>NCT01706848</nct_id>
  </id_info>
  <brief_title>Celotres for Improvement in Wound Healing and Resulting Scar Consequences Following Suturing of a Wound</brief_title>
  <acronym>PMCS EURO HEAL</acronym>
  <official_title>A Post Market Clinical Study Evaluating the Safety, Device Performance and Possible Emergent Risks of Celotres in the Improvement of Wound Healing and the Resulting Scar Consequences Following Suturing of a Wound</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Halscion, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Halscion, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to actively gather additional information on safety, device&#xD;
      performance and possible emergent risks following the use of Celotres in a post-market&#xD;
      setting when used to improve wound healing and the resulting scar consequences following&#xD;
      suturing of a wound.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Safety</measure>
    <time_frame>Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12</time_frame>
    <description>Safety as defined by the incidence of device related adverse events.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness</measure>
    <time_frame>Assessed at Months 1, 3, 6, 9 and 12</time_frame>
    <description>Patient and Observer Scar Assessment Scale (POSAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device Performance Evaluation</measure>
    <time_frame>Assessed at Day 1</time_frame>
    <description>Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Scar</condition>
  <arm_group>
    <arm_group_label>Celotres</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Scar halves randomized to treatment with device, opposite side treated per standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard surgical wound closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Scar halves randomized to treatment with device, opposite side treated per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Celotres</intervention_name>
    <description>Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.</description>
    <arm_group_label>Celotres</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surgical Closure by Standard of Care</intervention_name>
    <description>Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.</description>
    <arm_group_label>Standard surgical wound closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients electing to undergo a surgical procedure;&#xD;
&#xD;
          -  Patients able and willing to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known or potential risk of allergy or sensitivity to products or&#xD;
             substances containing porcine gelatin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Venkat Ramakrishnan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brentwood Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Angelius Szpital Proviat</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Leczenia Oparzen Chirugil Plastysznej</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Westbourne Center</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 3SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brentwood Hospital</name>
      <address>
        <city>Brentwood</city>
        <zip>CM15 8EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plastic Surgery W1 Ltd, Suite 1</name>
      <address>
        <city>London</city>
        <zip>W1G9LG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morriston Hospital</name>
      <address>
        <city>Swansea</city>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>May 24, 2014</last_update_submitted>
  <last_update_submitted_qc>May 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01706848
org study id: HAL-0297
nct id: NCT01706848
lead sponsor: 
has dmc: No
The objective of the study is to actively gather additional information on safety, device
      performance and possible emergent risks following the use of Celotres in a post-market
      setting when used to improve wound healing and the resulting scar consequences following
      suturing of a wound.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
description: Safety as defined by the incidence of device related adverse events.
measure: Effectiveness
time frame: Assessed at Months 1, 3, 6, 9 and 12
description: Patient and Observer Scar Assessment Scale (POSAS)
measure: Device Performance Evaluation
time frame: Assessed at Day 1
description: Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator
arm group label: Celotres
arm group type: Active Comparator
description: Scar halves randomized to treatment with device, opposite side treated per standard of care.
arm group label: Standard surgical wound closure
arm group type: Active Comparator
description: Scar halves randomized to treatment with device, opposite side treated per standard of care.
intervention type: Other
intervention name: Celotres
description: Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
arm group label: Celotres
intervention type: Other
intervention name: Surgical Closure by Standard of Care
description: Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
arm group label: Standard surgical wound closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Venkat Ramakrishnan, MD
role: Principal Investigator
affiliation: Brentwood Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Poland
country: United Kingdom
responsible party type: Sponsor