<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/NCT03782727</url>
  </required_header>
  <id_info>
    <org_study_id>RD 17/DEC/7165</org_study_id>
    <nct_id>NCT03782727</nct_id>
  </id_info>
  <brief_title>ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers</brief_title>
  <acronym>OASIS</acronym>
  <official_title>Observational Study to Estimate the Proportion of Post-operative Infection Following Excision of Ulcerated Skin Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardiff and Vale University Health Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cardiff University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UK Dermatology Clinical Trials Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cardiff and Vale University Health Board</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 investigators aim to recruit 311 participants to this study from three UK Dermatology&#xD;
      departments. The investigators will invite people with suspected skin cancers whose lesions&#xD;
      have a broken surface (also known as ulcerated) who will undergo surgery.&#xD;
&#xD;
      This study is being carried out because it is possible that patients with skin cancers with&#xD;
      ulceration might be at greater risk of developing a wound infection after surgery. The aim of&#xD;
      this study is to determine how many people with ulcerated skin cancers develop an infection&#xD;
      of the wound after it has been surgically removed.&#xD;
&#xD;
      People with ulcerated skin cancers who will have surgery will be invited to participate in&#xD;
      the study. If they agree, a member of the research team will explain the study and consent&#xD;
      them to participate in the study. At the time of surgery, information will be collected about&#xD;
      the participant, skin tumour and procedure. The participant will be given standardised advice&#xD;
      regarding wound care and further care will be as per each centre's 'normal clinical care'. If&#xD;
      participants are diagnosed with a wound infection then they will asked to take a 'wound&#xD;
      selfie' and share the photo with the research team. The research team will contact the&#xD;
      participant via a postal questionnaire which will be sent four weeks after the procedure to&#xD;
      determine whether they had any concerns about post-operative infection and whether any action&#xD;
      was taken.&#xD;
&#xD;
      Additionally, all participants at the University Hospital of Wales will have a surface swab&#xD;
      taken from their ulcerated skin cancer and these will be analysed in the Public Health Wales&#xD;
      laboratory at the University of Wales, Cardiff. The aim of this aspect of the study is to&#xD;
      identify the most common bacteria in ulcerated tumours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinicians in the dermatology departments will identify eligible participants at the time of&#xD;
      initial consultation. An information leaflet will be provided and details of the participants&#xD;
      who are interested in participating will be forwarded to the research team to check&#xD;
      eligibility prior to the procedure. Prior to the procedure relevant clinical information will&#xD;
      be recorded in the Case Report Form (CRF) including demographic data, tumour site, tumour&#xD;
      size, size of tumoural ulceration and type of wound closure. Histopathological data will be&#xD;
      collected on tumour type when it is reported. Participants and clinicians will be asked&#xD;
      whether they would agree for the patients to be randomised to no antibiotics, topical&#xD;
      treatment eg. InadineTM dressings, a short course of antibiotics or a longer course of&#xD;
      antibiotics in a future RCT. Following the procedure, information about whether oral&#xD;
      antibiotics were prescribed will be recorded on a standardized CRF. All participants will be&#xD;
      provided with the same information leaflet detailing standard post-operative advice and&#xD;
      further care will be as per each centre's 'standard clinical care' which will also be&#xD;
      recorded.&#xD;
&#xD;
      If participants are diagnosed with SSI they will be asked to take a photo of their wound on a&#xD;
      camera phone and then to share the photo with the Cardiff University Centre for Trials&#xD;
      Research (CTR) via email. Reeves et al. have described this practice as a 'wound selfie' and&#xD;
      report that the term is readily understood. If participants are not able to take of photo of&#xD;
      their wound then they will be invited to attend the department to have a photograph taken by&#xD;
      medical photography. All participants will be sent a questionnaire by the research team four&#xD;
      weeks following their procedure to enquire specifically whether the participant was diagnosed&#xD;
      and treated for wound infection. These data will be collected by Cardiff University CTR who&#xD;
      will co-ordinate the study.&#xD;
&#xD;
      Additionally, all participants at University Hospital of Wales will have a surface swab taken&#xD;
      from their ulcerated skin tumour and these will be analysed in the Public Health Wales&#xD;
      laboratory at the University of Wales, Cardiff. The aim of this aspect of the study is to&#xD;
      identify the most common organisms that colonise ulcerated tumours. Previous studies have&#xD;
      commented on growth from ulcerated tumours, however it is not clear if this was conducted in&#xD;
      a research laboratory setting. This will help to guide antibiotic choice in a future&#xD;
      randomized controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2019</start_date>
  <completion_date type="Actual">May 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To ascertain the proportion of surgical site infections following excision of ulcerated skin tumours in Dermatology Departments.</measure>
    <time_frame>Four weeks after surgery.</time_frame>
    <description>Proportion of participants with surgical site infection (SSI) identified by postal questionnaire four weeks after surgery.</description>
  </primary_outcome>
  <enrollment type="Actual">148</enrollment>
  <condition>Skin Cancer</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Participants enrolled to the study at University Hospital Cardiff will have swabs of&#xD;
      ulcerated skin tumours taken and analysed in the Public Health Wales laboratory at the&#xD;
      University of Wales, Cardiff.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People undergoing surgical excision of ulcerated skin cancer of any type at any body site&#xD;
        in the dermatology departments at the University Hospital of Wales Cardiff; Churchill&#xD;
        Hospital, Oxford and Queen Elizabeth Hospital, Birmingham.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) at least 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of wound infection at the time of the procedure&#xD;
&#xD;
          2. Skin tumour removal undertaken curettage or Mohs micrographic surgery&#xD;
&#xD;
          3. People without the capacity to consent for the study&#xD;
&#xD;
          4. People who are on systemic immunosuppressive treatment&#xD;
&#xD;
          5. People who are already taking oral antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <state>England</state>
        <zip>OX4 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiff and Vale University Health Board</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardiff and Vale University Health Board</investigator_affiliation>
    <investigator_full_name>Rachel Abbott</investigator_full_name>
    <investigator_title>Dermatology Consultant</investigator_title>
  </responsible_party>
  <keyword>skin cancer</keyword>
  <keyword>surgery</keyword>
  <keyword>ulcerated</keyword>
  <keyword>infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Skin Neoplasms</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 16, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03782727
org study id: RD 17/DEC/7165
nct id: NCT03782727
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aim to recruit 311 participants to this study from three UK Dermatology
      departments. The investigators will invite people with suspected skin cancers whose lesions
      have a broken surface (also known as ulcerated) who will undergo surgery.

      This study is being carried out because it is possible that patients with skin cancers with
      ulceration might be at greater risk of developing a wound infection after surgery. The aim of
      this study is to determine how many people with ulcerated skin cancers develop an infection
      of the wound after it has been surgically removed.

      People with ulcerated skin cancers who will have surgery will be invited to participate in
      the study. If they agree, a member of the research team will explain the study and consent
      them to participate in the study. At the time of surgery, information will be collected about
      the participant, skin tumour and procedure. The participant will be given standardised advice
      regarding wound care and further care will be as per each centre's 'normal clinical care'. If
      participants are diagnosed with a wound infection then they will asked to take a 'wound
      selfie' and share the photo with the research team. The research team will contact the
      participant via a postal questionnaire which will be sent four weeks after the procedure to
      determine whether they had any concerns about post-operative infection and whether any action
      was taken.

      Additionally, all participants at the University Hospital of Wales will have a surface swab
      taken from their ulcerated skin cancer and these will be analysed in the Public Health Wales
      laboratory at the University of Wales, Cardiff. The aim of this aspect of the study is to
      identify the most common bacteria in ulcerated tumours.
Clinicians in the dermatology departments will identify eligible participants at the time of
      initial consultation. An information leaflet will be provided and details of the participants
      who are interested in participating will be forwarded to the research team to check
      eligibility prior to the procedure. Prior to the procedure relevant clinical information will
      be recorded in the Case Report Form (CRF) including demographic data, tumour site, tumour
      size, size of tumoural ulceration and type of wound closure. Histopathological data will be
      collected on tumour type when it is reported. Participants and clinicians will be asked
      whether they would agree for the patients to be randomised to no antibiotics, topical
      treatment eg. InadineTM dressings, a short course of antibiotics or a longer course of
      antibiotics in a future RCT. Following the procedure, information about whether oral
      antibiotics were prescribed will be recorded on a standardized CRF. All participants will be
      provided with the same information leaflet detailing standard post-operative advice and
      further care will be as per each centre's 'standard clinical care' which will also be
      recorded.

      If participants are diagnosed with SSI they will be asked to take a photo of their wound on a
      camera phone and then to share the photo with the Cardiff University Centre for Trials
      Research (CTR) via email. Reeves et al. have described this practice as a 'wound selfie' and
      report that the term is readily understood. If participants are not able to take of photo of
      their wound then they will be invited to attend the department to have a photograph taken by
      medical photography. All participants will be sent a questionnaire by the research team four
      weeks following their procedure to enquire specifically whether the participant was diagnosed
      and treated for wound infection. These data will be collected by Cardiff University CTR who
      will co-ordinate the study.

      Additionally, all participants at University Hospital of Wales will have a surface swab taken
      from their ulcerated skin tumour and these will be analysed in the Public Health Wales
      laboratory at the University of Wales, Cardiff. The aim of this aspect of the study is to
      identify the most common organisms that colonise ulcerated tumours. Previous studies have
      commented on growth from ulcerated tumours, however it is not clear if this was conducted in
      a research laboratory setting. This will help to guide antibiotic choice in a future
      randomized controlled trial.
observational model: Case-Only
time perspective: Prospective
measure: To ascertain the proportion of surgical site infections following excision of ulcerated skin tumours in Dermatology Departments.
time frame: Four weeks after surgery.
description: Proportion of participants with surgical site infection (SSI) identified by postal questionnaire four weeks after surgery.
Participants enrolled to the study at University Hospital Cardiff will have swabs of
      ulcerated skin tumours taken and analysed in the Public Health Wales laboratory at the
      University of Wales, Cardiff.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Cardiff and Vale University Health Board
investigator full name: Rachel Abbott
investigator title: Dermatology Consultant
mesh term: Infections
mesh term: Skin Neoplasms
mesh term: Ulcer
sharing ipd: Undecided
submitted: March 16, 2023