RecruitingPhase IVInterventional

Examining antibiotics for ulcerated skin cancer surgical excision

This study is investigating if antibiotics can help prevent infections after surgery for a type of skin cancer that has caused a wound on the skin. Every year, many people in the UK have skin cancer removed, and those with ulcerated skin cancer are more likely to get an infection afterwards. Doctors often give antibiotics to prevent infections, but it's not clear if they always work or if they lead to unnecessary side effects or antibiotic resistance. In this study, participants will either receive a single dose of a common antibiotic called flucloxacillin or a dummy pill (placebo) before their surgery. Researchers will then check how many people in each group develop a wound infection. The results will help decide if antibiotics should be routinely given before this type of skin cancer surgery.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Cardiff and Vale University Health Board

Enrolment target

380

Start

10 Mar 2026

Estimated completion

01 Apr 2027

Antibiotic treatment for the prevention of surgical site infection in participants receiving ulcerated skin cancer excision

What is this study about?

Skin cancer is very common, and in the UK, about 200,000 people have skin cancer removed by surgery each year. Sometimes, skin cancer can break through the skin, creating an open wound. This is called 'ulcerated skin cancer'. People with this type of cancer are more likely to get a wound infection after their surgery.

Doctors often give antibiotics before surgery to try and stop these infections from happening. However, we don't actually know for sure if these antibiotics always help. Giving antibiotics when they're not really needed can sometimes cause side effects, like feeling sick, and can also lead to something called 'antibiotic resistance'. This is where bacteria become stronger and the antibiotics work less well in the future. This study aims to find out if giving a single dose of antibiotics before surgery for ulcerated skin cancer genuinely reduces the risk of wound infections.

To do this, some people having this surgery will be given an antibiotic called flucloxacillin, and others will receive a dummy pill (placebo) that looks like the antibiotic but contains no medicine. A computer will decide which one you get, so it's completely fair. By comparing the number of infections in both groups, the study hopes to give clear guidance to doctors on whether antibiotics are truly helpful in preventing infections for this specific type of surgery.

Key takeaways

This study investigates if a single antibiotic dose prevents wound infections after ulcerated skin cancer surgery.
Participation involves receiving either a common antibiotic (flucloxacillin) or a dummy pill.
You will receive extra monitoring and follow-up for your surgical wound.
The study helps determine if antibiotics are truly needed, which can reduce side effects and antibiotic resistance.
You won't know if you're receiving the antibiotic or the placebo, and neither will your doctors.
The study will run from March 2026 to December 2027.

Who may be eligible?

This study is looking for adults aged 16 or older who are having surgery for an ulcerated skin cancer that is visible on their skin. You must be undergoing surgery where the wound is closed up straight away and it's your first time taking part in this specific study.

You won't be able to join if you already have signs of a skin infection, or if your surgery involves specific methods like Mohs micrographic surgery, or if your wound will be left open to heal later. Also, if you’ve taken antibiotics recently (in the last 24 hours), have very poor kidney function, or have had a serious allergic reaction to penicillin in the past, you won't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Are you having surgery for skin cancer that has an open wound (ulcerated)?
Will your surgical wound be closed immediately after surgery?
Have you had a severe allergic reaction to penicillin before?
Are you currently taking oral antibiotics or have you taken them recently?
Do you have very poor kidney function?

Answer every question to see your result.

What does participation involve?

If you take part, before your surgery, a computer will randomly decide whether you receive a single dose of the antibiotic flucloxacillin or a dummy pill (placebo). You won't know which one you've been given, and neither will your doctors. Everyone in the study will get the usual wound care advice that the NHS provides.

After your surgery, you'll be given a booklet with photos to help you identify possible signs of infection. You'll be asked to contact the study team if you're worried about your wound. The study team will also contact you by phone or text several times after your surgery (between 5-10 days, 15-20 days, and around 30 days) to check on your wound, ask about any signs of infection, and see if you've had any side effects. If a wound infection is suspected, you'll be asked to come to the hospital for a check-up and receive any necessary treatment. You'll also be asked how long it took you to return to your normal activities. This close monitoring will last for about a month after your surgery.

Potential risks and benefits

By taking part in this study, you will help doctors understand whether antibiotics can reduce wound infections after surgery for ulcerated skin cancer. You will also receive closer monitoring of your wound than you normally would. The antibiotic used, flucloxacillin, is common and generally safe, but like all medicines, it can have side effects such as feeling sick, bloating, indigestion, or diarrhoea. You will be closely monitored, and if you experience any side effects, you should tell the study team, your GP, or go to A&E if urgent. Some participants will receive a dummy pill, which is unlikely to cause harm. There is a small chance you might feel some mild discomfort if wound swabs are needed for analysis. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (14)

University Hospital of Wales
Approximate
Cardiff, Wales
Walsall Manor Hospital
Approximate
Walsall, England
Castle Hill Hospital
Approximate
Cottingham, England
Churchill Hospital
Approximate
Oxford, England
James Cook University Hospital
Approximate
Middlesbrough, England
Royal Victoria Hospital
Approximate
Belfast, Northern Ireland
Stoke Mandeville Hospital
Approximate
Aylesbury, England
Morriston Hospital
Approximate
Swansea, Wales
Northampton General Hospital
Approximate
Northampton, England
Brighton General Hospital
Approximate
Brighton, England
Royal United Hospital
Unverified
Bath, England
Victoria Hospital, NHS Fife
Unverified
Kirkaldy, Scotland

Common questions

What is 'ulcerated skin cancer'?

It's a type of skin cancer that has caused an open wound or sore on the skin's surface.

Why don't doctors already know if antibiotics are needed?

While antibiotics are often given, there isn't clear scientific proof yet that they always help prevent infections after this specific type of surgery without sometimes causing unwanted side effects or antibiotic resistance.

What is a 'placebo'?

A placebo is a dummy pill that looks like the medicine being tested but does not contain any active drug. It helps compare the real medicine's effects fairly.

Will I know if I'm getting the antibiotic or the placebo?

No, neither you nor your doctors will know, so that the results of the study are unbiased.

How long will I be involved in the study?

Your direct involvement for monitoring your wound and side effects will primarily be for about one month after your surgery.

How to find out more

Burhan Ben Karatas

excise-ctr@cardiff.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.