<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/NCT03277131</url>
  </required_header>
  <id_info>
    <org_study_id>CT1701DUR</org_study_id>
    <nct_id>NCT03277131</nct_id>
  </id_info>
  <brief_title>DURAFIBER Ag Post-Market Clinical Follow-Up</brief_title>
  <official_title>A Prospective, Open, Non-Comparative Multicentre Study to Evaluate a Fibrous Silver Dressing (DURAFIBER™ Ag) in the Treatment of Moderate to Highly Exuding Venous Leg Ulcers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Smith &amp; Nephew, 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>
      The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many&#xD;
      bacteria are present in infected wounds over an 8 week period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many&#xD;
      bacteria are present in infected wounds over an 8 week period.&#xD;
&#xD;
      DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing&#xD;
      antimicrobial dressing for use on a variety of exuding wounds and is widely used in routine&#xD;
      clinical practice within the UK.&#xD;
&#xD;
      The primary outcome will be the quantitative reduction in bacterial load, based on a wound&#xD;
      biopsy, from baseline to week 8. Secondary objectives will include the quantitative reduction&#xD;
      in bacterial load, based on biopsy, from initial assessment to week 4, and the&#xD;
      semi-quantitative reduction in bacterial load, based on swab analysis, from baseline to weeks&#xD;
      4 and 8. Additionally dressing performance measures will be assessed as well as all adverse&#xD;
      events and device deficiencies.&#xD;
&#xD;
      In total 20 evaluable participants with an infected venous leg ulcer will be recruited into&#xD;
      the trial. All participants will have their wound dressed using DURAFIBER Ag and will be&#xD;
      followed-up for 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Actual">June 19, 2019</completion_date>
  <primary_completion_date type="Actual">June 19, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Wounds and Injuries</condition>
  <condition>Venous Leg Ulcer</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Antimicrobial Dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DURAFIBER Ag</intervention_name>
    <description>DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Inclusion Criteria to be confirmed at the initial assessment&#xD;
&#xD;
          -  The subject or must provide written informed consent.&#xD;
&#xD;
          -  Subjects must be at least eighteen (18) years of age.&#xD;
&#xD;
          -  Willing and able to make all required study visits.&#xD;
&#xD;
          -  Able to follow instructions.&#xD;
&#xD;
          -  Subjects must have a VLU, an ankle brachial pressure index (ABPI) taken within the&#xD;
             last 28 days of 0.8-1.3, and must be treated with compression therapy.&#xD;
&#xD;
          -  The subject must have a wound with an area ≥ 2cm².&#xD;
&#xD;
          -  The subject's wound must have moderate or high exudate levels.&#xD;
&#xD;
          -  The subject's reference wound must, in the opinion of the Healthcare Professional,&#xD;
             show signs of infection warranting treatment with DURAFIBER Ag.&#xD;
&#xD;
          -  In the clinician's opinion the subject's wound has an initial bacterial count of &gt; 104&#xD;
             cfu/g (which will be confirmed following the initial wound biopsy).&#xD;
&#xD;
        Inclusion criteria to be confirmed when the biopsy result is recorded:&#xD;
&#xD;
        -The subject's wound has a confirmed initial bacterial count of &gt; 104 cfu/g&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications or hypersensitivity to the use of the DURAFIBER Ag, ancillary&#xD;
             products or their components (e.g. known sensitivity to silver).&#xD;
&#xD;
          -  Participation in the treatment period of another clinical trial within thirty (30)&#xD;
             days of the date of consent.&#xD;
&#xD;
          -  Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which,&#xD;
             in the opinion of the Investigator, will interfere with the study assessments.&#xD;
&#xD;
          -  Subjects receiving topical antimicrobials or oil-based products (such as petrolatum)&#xD;
             at the reference wound surface.&#xD;
&#xD;
          -  Subjects being treated with immunosuppressive drugs or corticosteroids.&#xD;
&#xD;
          -  Subjects who have participated previously in this clinical trial and who have healed&#xD;
             or been withdrawn.&#xD;
&#xD;
          -  Subjects with a known history of poor compliance with medical treatment.&#xD;
&#xD;
          -  Subjects with a medical or physical condition that, in the opinion of the&#xD;
             Investigator, would preclude safe subject participation in the study.&#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>Helen Fearnley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bradford Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Huddleston, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Smith &amp; Nephew - Global Strategy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hull &amp; East Riding Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <state>East Yorkshire</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancashire Care NHS Foundation Trust</name>
      <address>
        <city>Preston</city>
        <state>Lancashire</state>
        <zip>PR2 8DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Foundation Trust</name>
      <address>
        <city>Barnsley</city>
        <state>South Yorkshire</state>
        <zip>S75 2EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff &amp; Vale University Healthcare Board</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northumbria Healthcare NHS Foundation Trust</name>
      <address>
        <city>Ashington</city>
        <zip>NE63 0HP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Bradford</city>
        <zip>BD9 6RJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Upon Tyne Hospitals NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <zip>NE3 3HD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>February 28, 2022</last_update_submitted>
  <last_update_submitted_qc>February 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 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>Varicose Ulcer</mesh_term>
    <mesh_term>Leg Ulcer</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03277131
org study id: CT1701DUR
nct id: NCT03277131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many
      bacteria are present in infected wounds over an 8 week period.
The aim of the study is to evaluate the performance of DURAFIBER Ag and to assess how many
      bacteria are present in infected wounds over an 8 week period.

      DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing
      antimicrobial dressing for use on a variety of exuding wounds and is widely used in routine
      clinical practice within the UK.

      The primary outcome will be the quantitative reduction in bacterial load, based on a wound
      biopsy, from baseline to week 8. Secondary objectives will include the quantitative reduction
      in bacterial load, based on biopsy, from initial assessment to week 4, and the
      semi-quantitative reduction in bacterial load, based on swab analysis, from baseline to weeks
      4 and 8. Additionally dressing performance measures will be assessed as well as all adverse
      events and device deficiencies.

      In total 20 evaluable participants with an infected venous leg ulcer will be recruited into
      the trial. All participants will have their wound dressed using DURAFIBER Ag and will be
      followed-up for 8 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the mean log10 bacterial count in tissue biopsies from baseline to week 8
time frame: 8 weeks
measure: Change in the mean log10 bacterial count from tissue biopsies from baseline to week 4.
time frame: 4 weeks
measure: The semi-quantitative presence of bacteria, bacteria type and species from the weekly swabs
time frame: 8 weeks
measure: Change in the number of subjects showing clinical signs of infection from baseline to weeks 4 and 8.
time frame: 8 weeks
arm group label: 1
arm group type: Experimental
description: Antimicrobial Dressing
intervention type: Device
intervention name: DURAFIBER Ag
description: DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing
arm group label: 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Helen Fearnley
role: Principal Investigator
affiliation: Bradford Teaching Hospitals NHS Foundation Trust
last name: Elizabeth Huddleston, PhD
role: Study Chair
affiliation: Smith & Nephew - Global Strategy
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Varicose Ulcer
mesh term: Leg Ulcer
mesh term: Wounds and Injuries
sharing ipd: No