<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/NCT02992951</url>
  </required_header>
  <id_info>
    <org_study_id>R2034</org_study_id>
    <nct_id>NCT02992951</nct_id>
  </id_info>
  <brief_title>DACC in the REduction of Surgical Site INfection</brief_title>
  <acronym>DRESSINg</acronym>
  <official_title>A Randomised Controlled Trial to Assess the Clinical and Cost Effectiveness of Dialkylcarbamoylchloride (DACC) Coated Post-operative Dressings Versus Standard Care in the Prevention of Surgical Site Infection in Clean or Clean-contaminated, Vascular Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Hull</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hull University Teaching Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Surgical site infection is an infection at a place in the body where surgery has taken place,&#xD;
      and has been reported in around 5% of people undergoing an operation. In vascular surgery,&#xD;
      infection rates are as high as 30%. Methods to reduce this rate of infection should be&#xD;
      investigated thoroughly for their effectiveness and cost-effectiveness.&#xD;
&#xD;
      The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact&#xD;
      is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts&#xD;
      with, and binds bacteria, causing them to be mechanically removed from a wound when the&#xD;
      dressing is changed.The trial aims to compare the effectiveness of this dressing to a&#xD;
      standard, non-coated dressing, in the reduction of surgical site infection.&#xD;
&#xD;
      718 patients from a number of centres across the UK will be recruited to this study. Adult&#xD;
      patients who are having a vascular surgery operation will be approached for entry into the&#xD;
      trial. The trial will be explained to them, as well as an explanation that participation is&#xD;
      voluntary and their operation or other aspects of their care will not be impacted in any way&#xD;
      should participants not wish to participate.&#xD;
&#xD;
      Participants will be randomised by computer into one of two groups - one group whose wounds&#xD;
      are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard&#xD;
      dressing. Patients will be followed up at 5-7 days and 30 days, and at 1 year. At the follow&#xD;
      up, their wounds will be inspected for infection, and participants will be asked to complete&#xD;
      short questionnaires measuring quality of life.&#xD;
&#xD;
      The trial will aim to answer a number of questions, with the primary question being does a&#xD;
      DACC coated dressing applied after an operation reduce the risk of an infection at the&#xD;
      surgery site? It will also ask whether this treatment is cost-effective and whether it&#xD;
      promotes satisfactory healing.&#xD;
&#xD;
      A Study Within a Trial will validate a remote diagnostic measure for detecting surgical site&#xD;
      infection using wound images and the Bluebelle Wound Healing Questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2025</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30 day infection rate</measure>
    <time_frame>30 days</time_frame>
    <description>Surgical Site Infection at 30 days post-op</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 year infection rate</measure>
    <time_frame>1 year</time_frame>
    <description>Surgical Site Infection at 1 year post-op (implant patients only)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (SF-36 V2)</measure>
    <time_frame>7 days, 30 days, 3 months, 6 months, 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (EQ-5D-5L)</measure>
    <time_frame>7 days, 30 days, 3 months, 6 months, 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>30-day mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bluebelle wound healing questionnaire</measure>
    <time_frame>Days 30 and 37</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">718</enrollment>
  <condition>Infection, Bacterial</condition>
  <condition>Wound Infection</condition>
  <condition>Wound Infection, Surgical</condition>
  <condition>Surgical Incision</condition>
  <condition>Surgical Wound</condition>
  <arm_group>
    <arm_group_label>DACC-Coated Post-Operative Dressing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DACC-Coated Post-Operative Dressing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-DACC coated Occlusive Post-operative Film Dressing</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-DACC coated Occlusive Post-operative Film Dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DACC-Coated Post Operative Dressing</intervention_name>
    <description>Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.</description>
    <arm_group_label>DACC-Coated Post-Operative Dressing</arm_group_label>
    <other_name>Leukomed Sorbact</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In order to be eligible for inclusion in the study the participants must meet the following&#xD;
        criteria:&#xD;
&#xD;
          -  Adults ≥18 yrs undergoing clean or clean-contaminated lower limb vascular surgery,&#xD;
             with wounds closed by primary intention.&#xD;
&#xD;
          -  Able to understand the Patient Information Sheet and supplementary materials and&#xD;
             capable and willing to give informed consent and follow the protocol requirements&#xD;
             (including attending all follow-up visits and completing written questionnaires).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will not be included in the study if they meet any of the following exclusion&#xD;
        criteria:&#xD;
&#xD;
          -  Patients on antibiotics for other conditions at the time of surgery or in the follow&#xD;
             up period.&#xD;
&#xD;
          -  Patients undergoing any procedure that does not include lower limb incisions.&#xD;
&#xD;
          -  Allergies to any component of either the DACC-coated dressing or the control dressing.&#xD;
&#xD;
          -  Inability to give informed consent due to incapacity (as defined by the MCA 2005)&#xD;
&#xD;
          -  Aged under 18 years at the time of recruitment&#xD;
&#xD;
          -  Use of investigational drug/device therapy within preceding 4 weeks that may interfere&#xD;
             with this 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>George Smith, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hull and East Yorkshire NHS Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ross Lathan, MBBS</last_name>
    <phone>01482674643</phone>
    <email>ross.lathan2@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Judith Long</last_name>
    <phone>01482 675784</phone>
    <email>judith.long2@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Academic Vascular Surgery Unit, Vascular Laboratory, Alderson House, Hull Royal Infirmary</name>
      <address>
        <city>Hull</city>
        <state>East Riding Of Yorkshire</state>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ross Lathan, MbChB</last_name>
      <phone>01482674643</phone>
      <email>ross.lathan2@nhs.net</email>
    </contact>
    <investigator>
      <last_name>George E Smith, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ian C Chetter, M.D</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Joshua P Totty, MBBS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paris L Cai, MbChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ross Lathan, MbChB</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0400-2</url>
    <description>Abstract Link</description>
  </link>
  <reference>
    <citation>Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019.</citation>
    <PMID>30680225</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infection</keyword>
  <keyword>Surgical Site Infection</keyword>
  <keyword>Dialkylcarbamoylchloride</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Bacterial Infections</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</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/NCT02992951
org study id: R2034
nct id: NCT02992951
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgical site infection is an infection at a place in the body where surgery has taken place,
      and has been reported in around 5% of people undergoing an operation. In vascular surgery,
      infection rates are as high as 30%. Methods to reduce this rate of infection should be
      investigated thoroughly for their effectiveness and cost-effectiveness.

      The investigators aim to conduct a research trial examining one such method. Leukomed Sorbact
      is a wound dressing coated with a chemical (DACC) derived from spider-silk that interacts
      with, and binds bacteria, causing them to be mechanically removed from a wound when the
      dressing is changed.The trial aims to compare the effectiveness of this dressing to a
      standard, non-coated dressing, in the reduction of surgical site infection.

      718 patients from a number of centres across the UK will be recruited to this study. Adult
      patients who are having a vascular surgery operation will be approached for entry into the
      trial. The trial will be explained to them, as well as an explanation that participation is
      voluntary and their operation or other aspects of their care will not be impacted in any way
      should participants not wish to participate.

      Participants will be randomised by computer into one of two groups - one group whose wounds
      are dressed with Leukomed Sorbact, and the other whose wounds are dressed with a standard
      dressing. Patients will be followed up at 5-7 days and 30 days, and at 1 year. At the follow
      up, their wounds will be inspected for infection, and participants will be asked to complete
      short questionnaires measuring quality of life.

      The trial will aim to answer a number of questions, with the primary question being does a
      DACC coated dressing applied after an operation reduce the risk of an infection at the
      surgery site? It will also ask whether this treatment is cost-effective and whether it
      promotes satisfactory healing.

      A Study Within a Trial will validate a remote diagnostic measure for detecting surgical site
      infection using wound images and the Bluebelle Wound Healing Questionnaire.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 30 day infection rate
time frame: 30 days
description: Surgical Site Infection at 30 days post-op
measure: 1 year infection rate
time frame: 1 year
description: Surgical Site Infection at 1 year post-op (implant patients only)
measure: Quality of Life (SF-36 V2)
time frame: 7 days, 30 days, 3 months, 6 months, 1 year
measure: Quality of Life (EQ-5D-5L)
time frame: 7 days, 30 days, 3 months, 6 months, 1 year
measure: Mortality
time frame: 30 days
description: 30-day mortality
measure: Bluebelle wound healing questionnaire
time frame: Days 30 and 37
arm group label: DACC-Coated Post-Operative Dressing
arm group type: Experimental
description: DACC-Coated Post-Operative Dressing
arm group label: Non-DACC coated Occlusive Post-operative Film Dressing
arm group type: No Intervention
description: Non-DACC coated Occlusive Post-operative Film Dressing
intervention type: Device
intervention name: DACC-Coated Post Operative Dressing
description: Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.
arm group label: DACC-Coated Post-Operative Dressing
other name: Leukomed Sorbact
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: George Smith, M.D
role: Principal Investigator
affiliation: Hull and East Yorkshire NHS Trust
last name: Ross Lathan, MBBS
phone: 01482674643
email: ross.lathan2@nhs.net
last name: Judith Long
phone: 01482 675784
email: judith.long2@nhs.net
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United Kingdom
url: https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0400-2
description: Abstract Link
citation: Totty JP, Harwood AE, Cai PL, Hitchman LH, Smith GE, Chetter IC. Assessing the effectiveness of dialkylcarbamoylchloride (DACC)-coated post-operative dressings versus standard care in the prevention of surgical site infection in clean or clean-contaminated, vascular surgery (the DRESSINg trial): study protocol for a pilot feasibility randomised controlled trial. Pilot Feasibility Stud. 2019 Jan 18;5:11. doi: 10.1186/s40814-019-0400-2. eCollection 2019.
PMID: 30680225
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Wound Infection
mesh term: Bacterial Infections
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No