<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/NCT02228122</url>
  </required_header>
  <id_info>
    <org_study_id>UoM Study REF: 14118</org_study_id>
    <nct_id>NCT02228122</nct_id>
  </id_info>
  <brief_title>The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Angela Oates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ConvaTec Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic&#xD;
      wound bacterial biofilms&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Chronic wounds and wound infections can be costly, resulting in prolonged&#xD;
      hospital stays and an increased risk of secondary infection and septicaemia. In the UK the&#xD;
      management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical&#xD;
      site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds&#xD;
      typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent&#xD;
      biofilm formation has been cited as a factor which induces a chronic inflammatory state and&#xD;
      delays healing times.&#xD;
&#xD;
      AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a&#xD;
      gel when it becomes wet. Its physical characteristics have the potential to increase the&#xD;
      speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound&#xD;
      bioburden. Removing these potential barriers to healing may help towards wound progression.&#xD;
&#xD;
      Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on&#xD;
      chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the&#xD;
      presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the&#xD;
      baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume&#xD;
      over the treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.</measure>
    <time_frame>up to day 28</time_frame>
    <description>Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Size of the wound and an indicator of healing</measure>
    <time_frame>up to day 28</time_frame>
    <description>Weekly measurements of wound size</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Diabetes</condition>
  <condition>Chronic Foot Wounds</condition>
  <arm_group>
    <arm_group_label>Aquacel® Ag+ Extra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aquacel® Ag+ Extra</intervention_name>
    <description>Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks.</description>
    <arm_group_label>Aquacel® Ag+ Extra</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provided written informed consent&#xD;
&#xD;
          -  Be over 18 years of age&#xD;
&#xD;
          -  Must have a chronic foot wound greater than 4 weeks in duration&#xD;
&#xD;
          -  Be willing and able to attend the clinic for the required study visits -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history of sensitivity to any one of the components of the device&#xD;
             being studied&#xD;
&#xD;
          -  Subjects who have any other medical condition which, according to the investigator&#xD;
             justifies exclusion from the study&#xD;
&#xD;
          -  Subjects who are currently participating in or have been on a clinical study within&#xD;
             the last 4 weeks.&#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>Andrew J McBain, BSc, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Angela Oates, BSc, MSc, PhD, FIBMS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Manchester Diabetes Centre</name>
      <address>
        <city>Manchester</city>
        <zip>M13 0JE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Dr Angela Oates</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Chronic wounds</keyword>
  <keyword>Biofilms</keyword>
  <keyword>Bacteria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboxymethylcellulose Sodium</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/NCT02228122
org study id: UoM Study REF: 14118
nct id: NCT02228122
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic
      wound bacterial biofilms
Background: Chronic wounds and wound infections can be costly, resulting in prolonged
      hospital stays and an increased risk of secondary infection and septicaemia. In the UK the
      management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical
      site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds
      typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent
      biofilm formation has been cited as a factor which induces a chronic inflammatory state and
      delays healing times.

      AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a
      gel when it becomes wet. Its physical characteristics have the potential to increase the
      speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound
      bioburden. Removing these potential barriers to healing may help towards wound progression.

      Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on
      chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the
      presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the
      baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume
      over the treatment period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.
time frame: up to day 28
description: Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms.
measure: Size of the wound and an indicator of healing
time frame: up to day 28
description: Weekly measurements of wound size
arm group label: Aquacel® Ag+ Extra
arm group type: Experimental
intervention type: Device
intervention name: Aquacel® Ag+ Extra
description: Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks.
arm group label: Aquacel® Ag+ Extra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew J McBain, BSc, PhD
role: Principal Investigator
affiliation: University of Manchester
last name: Angela Oates, BSc, MSc, PhD, FIBMS
role: Principal Investigator
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: University of Manchester
investigator full name: Dr Angela Oates
investigator title: Dr
mesh term: Wounds and Injuries
mesh term: Carboxymethylcellulose Sodium