<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/NCT02217202</url>
  </required_header>
  <id_info>
    <org_study_id>Ortho 1302</org_study_id>
    <nct_id>NCT02217202</nct_id>
  </id_info>
  <brief_title>Study of AQUACEL™ Ag Surgical Cover Dressing Following Total Knee Replacement</brief_title>
  <official_title>Prospective Cohort Study of the AQUACEL™ Ag SURGICAL Cover Dressing in Total Knee Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Golden Jubilee National Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ConvaTec Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Golden Jubilee National Hospital</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 determine whether the AQUACEL™ Ag SURGICAL cover dressing is&#xD;
      successful in reducing the incidence of wound infection in high risk patients following total&#xD;
      knee replacement. We will also look at the status of the wound, occurrence of blistering,&#xD;
      biochemistry results, dressing wear time and the number of dressing changes to quantify the&#xD;
      dressing performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All eligible patients over a two month period will be identified and invited to take part in&#xD;
      the study. Identification will be done though examination of clinical case notes of patients&#xD;
      who are candidates for total knee replacement or revision surgery. Demographic and medical&#xD;
      history data for all study patients will be collected. This will include age, gender, BMI,&#xD;
      smoking habits, alcohol consumption, diagnosis, operation, laterality and comorbidities. All&#xD;
      eligible patients who fulfil the selection criteria will be informed of the study at their&#xD;
      pre-surgery consultation, provided with the patient information sheet and approached to take&#xD;
      part in the study at a later date.&#xD;
&#xD;
      Patients who have agreed to take part in the study will have their knee surgery performed in&#xD;
      the same manner as if they had not agreed to take part. The clinical team will be informed of&#xD;
      a patient's participation in the study and will ensure that the AQUACEL™ Ag SURGICAL cover&#xD;
      dressing is used instead of the standard dressing protocol with these patients, both&#xD;
      immediately after surgery and at any other time when the patient requires the dressing to be&#xD;
      changed before discharge. Study patients will also be given a sufficient supply of the&#xD;
      dressing for home use on discharge from the hospital.&#xD;
&#xD;
      Patients will be observed during their inpatient stay where data including the wound status,&#xD;
      occurrence of blistering, dressing wear time, number of dressing changes, ease of dressing&#xD;
      changes, any unforeseen side effects and any surgical site infection will be recorded to&#xD;
      quantify the dressing performance by the healthcare staff. Appropriate data from lab results&#xD;
      will be extracted. After discharge, data will be collected from the Prevention and Control of&#xD;
      Infection team at regular intervals up to 30 days postoperatively. Study patients will be&#xD;
      followed up, as per hospital protocol, at six weeks by the Arthroplasty Outcomes team. Data&#xD;
      from this follow up will also be included in the study. After this appointment, patients will&#xD;
      no longer have any involvement in the study.&#xD;
&#xD;
      Once the data set is completed statistical analysis will be carried out to compare the&#xD;
      results of this study with those of a retrospective cohort study of a similar patient group,&#xD;
      where the Jubilee method dressing (a combination of DuoDERM® and AQUACEL® was used).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding withdrawn before ethical approval granted&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2050</start_date>
  <completion_date type="Anticipated">January 2050</completion_date>
  <primary_completion_date type="Anticipated">January 2050</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of surgical site infections.</measure>
    <time_frame>Up to 6 weeks post-operatively.</time_frame>
    <description>What is the incidence of surgical site infections following total knee replacements and revisions in high risk patients when using the AQUACEL™ Ag SURGICAL cover dressing?</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dressing performance.</measure>
    <time_frame>Up to 6 weeks post-operatively.</time_frame>
    <description>How does the AQUACEL™ Ag SURGICAL cover dressing perform in terms of the occurrence of blistering, dressing wear time and the number of dressing changes, ease of use and number of unforeseen complications?</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>ConvaTec Ag</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aquacel Ag dressing</intervention_name>
    <description>Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.</description>
    <arm_group_label>ConvaTec Ag</arm_group_label>
    <other_name>Convatec Aquacel Ag dressing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 40&#xD;
&#xD;
          -  Revision of total knee replacement&#xD;
&#xD;
          -  Rheumatoid arthritis or secondary arthritis&#xD;
&#xD;
          -  Patients on Warfarin&#xD;
&#xD;
          -  Patients on steroids&#xD;
&#xD;
          -  Patients on long term antibiotics&#xD;
&#xD;
          -  Previous deep joint infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to silver&#xD;
&#xD;
          -  Simultaneous bilateral total knee replacement patients&#xD;
&#xD;
          -  Patients who do not wish to participate&#xD;
&#xD;
          -  Patients who are unable to give informed consent&#xD;
&#xD;
          -  Patients who are unable to attend Golden Jubilee National Hospital for follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alistair M Ewen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Golden Jubilee National Hospital</affiliation>
  </overall_official>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>July 29, 2019</last_update_submitted>
  <last_update_submitted_qc>July 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Golden Jubilee National Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Alistair Ewen</investigator_full_name>
    <investigator_title>Orthopaedic Researcher</investigator_title>
  </responsible_party>
  <keyword>knee replacement</keyword>
  <keyword>knee arthroplasty</keyword>
  <keyword>revision</keyword>
  <keyword>high risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</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/NCT02217202
org study id: Ortho 1302
nct id: NCT02217202
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine whether the AQUACEL™ Ag SURGICAL cover dressing is
      successful in reducing the incidence of wound infection in high risk patients following total
      knee replacement. We will also look at the status of the wound, occurrence of blistering,
      biochemistry results, dressing wear time and the number of dressing changes to quantify the
      dressing performance.
All eligible patients over a two month period will be identified and invited to take part in
      the study. Identification will be done though examination of clinical case notes of patients
      who are candidates for total knee replacement or revision surgery. Demographic and medical
      history data for all study patients will be collected. This will include age, gender, BMI,
      smoking habits, alcohol consumption, diagnosis, operation, laterality and comorbidities. All
      eligible patients who fulfil the selection criteria will be informed of the study at their
      pre-surgery consultation, provided with the patient information sheet and approached to take
      part in the study at a later date.

      Patients who have agreed to take part in the study will have their knee surgery performed in
      the same manner as if they had not agreed to take part. The clinical team will be informed of
      a patient's participation in the study and will ensure that the AQUACEL™ Ag SURGICAL cover
      dressing is used instead of the standard dressing protocol with these patients, both
      immediately after surgery and at any other time when the patient requires the dressing to be
      changed before discharge. Study patients will also be given a sufficient supply of the
      dressing for home use on discharge from the hospital.

      Patients will be observed during their inpatient stay where data including the wound status,
      occurrence of blistering, dressing wear time, number of dressing changes, ease of dressing
      changes, any unforeseen side effects and any surgical site infection will be recorded to
      quantify the dressing performance by the healthcare staff. Appropriate data from lab results
      will be extracted. After discharge, data will be collected from the Prevention and Control of
      Infection team at regular intervals up to 30 days postoperatively. Study patients will be
      followed up, as per hospital protocol, at six weeks by the Arthroplasty Outcomes team. Data
      from this follow up will also be included in the study. After this appointment, patients will
      no longer have any involvement in the study.

      Once the data set is completed statistical analysis will be carried out to compare the
      results of this study with those of a retrospective cohort study of a similar patient group,
      where the Jubilee method dressing (a combination of DuoDERM® and AQUACEL® was used).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Incidence of surgical site infections.
time frame: Up to 6 weeks post-operatively.
description: What is the incidence of surgical site infections following total knee replacements and revisions in high risk patients when using the AQUACEL™ Ag SURGICAL cover dressing?
measure: Dressing performance.
time frame: Up to 6 weeks post-operatively.
description: How does the AQUACEL™ Ag SURGICAL cover dressing perform in terms of the occurrence of blistering, dressing wear time and the number of dressing changes, ease of use and number of unforeseen complications?
arm group label: ConvaTec Ag
arm group type: Experimental
description: Use of ConvaTec Ag sugical cover dressing post-operatively until wound has healed.
intervention type: Device
intervention name: Aquacel Ag dressing
description: Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.
arm group label: ConvaTec Ag
other name: Convatec Aquacel Ag dressing
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alistair M Ewen, PhD
role: Principal Investigator
affiliation: Golden Jubilee National Hospital
responsible party type: Principal Investigator
investigator affiliation: Golden Jubilee National Hospital
investigator full name: Dr. Alistair Ewen
investigator title: Orthopaedic Researcher
mesh term: Osteoarthritis
mesh term: Carboxymethylcellulose Sodium