ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers

NCT03782727 | Completed Results

• 1 other identifier: RD 17/DEC/7165
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Skin Cancer

Keywords

skin cancer; surgery; ulcerated; infection

Outcome Measures

Primary Outcomes (1)

• 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.

  Four weeks after surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \) at least 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• Cardiff University: collaborator
• UK Dermatology Clinical Trials Network: collaborator

Study Sites (3)

Oxford University Hospitals NHS Foundation Trust

Oxford, England, OX4 2PG, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff, Wales, CF14 4XW, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Skin Neoplasms; Ulcer; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Rachel Abbott
• Organization: Cardiff and Vale University Health Board

rachel.abbott@wales.nhs.uk

02920743181

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology Consultant

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 20, 2018
• Study Start: March 12, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-12

Locations

GB (3)