N/A
N=148
ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers
Skin Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03782727 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments. — 35 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiff and Vale University Health Board
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Ascertain the Percentage of Surgical Site Infections Following Excision of Ulcerated Skin Tumours in Dermatology Departments. |
35 | — |
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.
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.
Eligibility Criteria
Inclusion Criteria
- at least 18 years old
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03782727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.