Skin CancerOASISNCT03782727
ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers
An observational study of Skin Cancer, run by Cardiff and Vale University Health Board at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- How many people
- 148 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 12 Mar 2019to 31 May 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People undergoing surgical excision of ulcerated skin cancer of any type at any body site in the dermatology departments at the University Hospital of Wales Cardiff; Churchill Hospital, Oxford and Queen Elizabeth Hospital, Birmingham.
Who may be able to join
- 1) at least 18 years old
Who cannot join
- Evidence of wound infection at the time of the procedure
- Skin tumour removal undertaken curettage or Mohs micrographic surgery
- People without the capacity to consent for the study
- People who are on systemic immunosuppressive treatment
- People who are already taking oral antibiotics
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Cardiff and Vale University Health Board
Cardiff, Wales, CF14 4XW
Oxford University Hospitals NHS Foundation Trust
Oxford, England, OX4 2PG
About this study
Official title: Observational Study to Estimate the Proportion of Post-operative Infection Following Excision of Ulcerated Skin Tumours
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Skin Cancer
- Keywords
- skin cancer, surgery, ulcerated, infection
- Medical subject headings
- Skin Neoplasms, Ulcer, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments.
Percentage of participants with surgical site infection (SSI) identified by online/ postal questionnaire (Bluebelle Wound Healing Questionnaire) four weeks after surgery.
Measured: Four weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start12 Mar 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- Cardiff University, UK Dermatology Clinical Trials Network
- Responsible party
- Principal investigator, Rachel Abbott, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782727
- Sponsor's protocol ID
- RD 17/DEC/7165
- Acronym
- OASIS
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2018
- Last updated
- 21 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Estimate the Proportion of Post-operative Infection Following Excision of Ulcerated Skin Tumours
- ClinicalTrials.gov ID
- NCT03782727
- Acronym / sponsor ID
- OASIS / RD 17/DEC/7165
- Conditions
- Skin Cancer
- Keywords
- skin cancer, surgery, ulcerated, infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- Cardiff University, UK Dermatology Clinical Trials Network
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 21 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People undergoing surgical excision of ulcerated skin cancer of any type at any body site in the dermatology departments at the University Hospital of Wales Cardiff; Churchill Hospital, Oxford and Queen Elizabeth Hospital, Birmingham.
Key inclusion criteria (1 listed)
- 1) at least 18 years old
Key exclusion criteria (5 listed)
- Evidence of wound infection at the time of the procedure
- Skin tumour removal undertaken curettage or Mohs micrographic surgery
- People without the capacity to consent for the study
- People who are on systemic immunosuppressive treatment
- People who are already taking oral antibiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments.
Time frame: Four weeks after surgery.
Percentage of participants with surgical site infection (SSI) identified by online/ postal questionnaire (Bluebelle Wound Healing Questionnaire) four weeks after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, run by Cardiff and Vale University Health Board at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments. (time frame: Four weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.