ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers
NCT ID: NCT03782727
Last Updated: 2023-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
148 participants
OBSERVATIONAL
2019-03-12
2020-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Skin tumour removal undertaken curettage or Mohs micrographic surgery
3. People without the capacity to consent for the study
4. People who are on systemic immunosuppressive treatment
5. People who are already taking oral antibiotics
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cardiff University
OTHER
UK Dermatology Clinical Trials Network
NETWORK
Cardiff and Vale University Health Board
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rachel Abbott
Dermatology Consultant
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Oxford University Hospitals NHS Foundation Trust
Oxford, England, United Kingdom
Cardiff and Vale University Health Board
Cardiff, Wales, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Consent form
Document Type: Informed Consent Form: Patient Information leaflet
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RD 17/DEC/7165
Identifier Type: -
Identifier Source: org_study_id