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ObservAtional Study to Investigate Surgical Site Infection in Ulcerated Skin Cancers

NCT03782727 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 148

Last updated 2023-12-21

Study results available
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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

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • UK Dermatology Clinical Trials Network

    collaborator NETWORK

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782727 on ClinicalTrials.gov