Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mr Burhan Ben Karatas
excise-ctr@cardiff.ac.uk


Dr Rachel Abbott
rachel.abbott@wales.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Examining antibiotics for ulcerated skin cancer surgical excision
Back

Examining antibiotics for ulcerated skin cancer surgical excision

Recruiting

Open to: All Genders

Age: Mixed

Cardiff Norwich Oxford Middlesbrough Walsall Cottingham Aylesbury Swansea Bath Bury St. Edmunds Brighton Kirkaldy Belfast Northampton

Medical Conditions

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

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Skin cancer is the most common type of cancer. Every year in the UK, around 200,000 people have their skin cancer removed surgically. Some people develop skin cancers that break through the skin surface, causing a wound on the skin (called an ulcerated skin cancer), which are six times more likely to develop a wound infection after surgery. Doctors often prescribe antibiotics at the time of surgery to prevent wound infections, but it is unknown whether antibiotics reduce the risk of getting an infection. Using more antibiotics than are needed may lead to patients having unnecessary side effects and lead to the bacteria causing the infection becoming resistant to antibiotics, which then work less well in the future. The study looks at whether antibiotics should be prescribed to patients at the time of surgically removing their ulcerated skin cancer to reduce their risk of wound infection. Participants will be given a one-off dose of antibiotic or no antibiotic (dummy pill called placebo). The study will see how many in each group develop wound infections. This will help to decide whether antibiotics should be given to patients before skin surgery.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

10 Mar 2026 01 Apr 2027

Before surgery, participants will be randomly allocated by a computer to have a one-off dose of a common antibiotic or no antibiotics (placebo). Everyone will receive the same wound care advice that they normally get as part of their NHS treatment. Participants will be asked to contact us if they are worried about their wound, and they will receive a photo booklet to help identify potential infections. They will be contacted between days 5-10, 15-20 and 30 days after surgery to ask about their wound, signs of infection and side effects. Participants will be seen in the hospital if a wound infection is suspected, and all will receive additional treatment if required. They will also be asked how long it took to return to normal activity, and the impact on daily activities.


Patients with ulcerated skin cancers from participating UK NHS hospitals.

You can take part if:



You may not be able to take part if:


1. Clinical evidence of skin cancer infection at baseline using CDC criteria.2. Skin tumour removal planned with curettage, Mohs micrographic surgery/ margin-controlled excision or shave excision.3. Wound left for delayed reconstruction or secondary intention healing or closed with dermal substitute.4. Concurrent oral antibiotic treatment (<24 hours after last dose).5. Documented poor renal function (creatinine clearance < 10ml/min).6. Previous allergic reaction to penicillin.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • Norfolk and Norwich University Hospitals NHS Foundation Trust
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Churchill Hospital
    Old Road Headington
    Oxford
    OX3 7LE
  • James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • Walsall Manor Hospital
    Moat Road
    Walsall
    WS2 9PS
  • Castle Hill Hospital
    Castle Road
    Cottingham
    HU16 5JQ
  • Stoke Mandeville Hospital
    Mandeville Road
    Aylesbury
    HP21 8AL
  • Morriston Hospital
    Heol Maes Eglwys Cwmrhydyceirw
    Swansea
    SA6 6NL
  • Royal United Hospital
    Combe Park
    Bath
    BA1 3NG
  • West Suffolk NHS Foundation Trust
    West Suffolk Hospital Hardwick Lane
    Bury St. Edmunds
    IP33 2QZ
  • Brighton General Hospital
    Elm Grove
    Brighton
    BN2 3EW
  • Victoria Hospital, NHS Fife
    Department of Oral and Maxillofacial Surgery, Hayfield Road
    Kirkaldy
    KY2 5AH
  • Royal Victoria Hospital
    Department of Dermatology, Belfast HSCNI Trust
    Belfast
    BT12 6BA
  • Northampton General Hospital
    Cliftonville
    Northampton
    NN1 5BD

By taking part in this trial, regardless of which treatment is received by participants, they will be helping to determine if antibiotics given just before surgery can reduce the number of wound infections seen in patients who have this type of surgery. Participants will be followed up more closely than they would be if they were not taking part in the trial.
The antibiotic, flucloxacillin, has been used for a long time for treating skin and wound infections and has a low risk of side effects that will cause no harm to pregnant/ breastfeeding participants or male participants’ partners. However, some common side effects include feeling sick, bloating, indigestion and diarrhoea. Participants will be closely monitored as part of their usual care. If participants do experience side effects, they will be encouraged to let their local recruitment site know, or if urgent, contact their GP or emergency department. Oral flucloxacillin is currently in use in the UK NHS to reduce SSI risk following skin cancer surgery. A multi-speciality clinician survey (n=129) conducted in 2021 reported that peri-operative antibiotics were ’always’/ ’often’/ ’sometimes’ prescribed for excision of ulcerated skin cancers by 49% of respondents and ’rarely/ never’ by 51%, demonstrating clinical equipoise. This demonstrates that both the use and non-use of the proposed intervention in the EXCISE trial are considered the current standard of practice for skin cancer surgery in the NHS. To minimise risk, potential participants with documented poor renal function (creatinine clearance < 10ml/min) or with a previous allergic reaction to penicillin will be excluded from participation. In addition to the eligibility criteria, other risk mitigation strategies include trial oversight from the Trial Management Group (TMG), Independent Data Monitoring Committee (IDMC) and Trial Steering Committee (TSC).
Participants may also be randomised to receive a placebo. This is unlikely to cause any harm as it does not contain any of the active ingredients, although it is possible that a participant could react with the excipient.
If they are diagnosed with a wound infection, they will be asked to attend their local recruiting site for review. If they are diagnosed with a surgical site infection, they will have swabs taken of the wound for antimicrobial resistance analysis in addition to those taken for standard care. These wound swabs may cause some slight discomfort. Participants will be offered compensation for travel to their local recruiting site if required to ensure that the participant is not disadvantaged.
Completion of patient diaries, taking wound photos and answering questionnaires about their health is not anticipated to cause any pain, discomfort, distress or intrusion, although it will take up participants' time.
Additionally, a selection of participants, those who declined to participate and health care professionals will be asked to take part in a semi-structured interview about their experience of taking part in the trial. It is not likely to involve any particular risks, although participating in such a discussion may bring back memories of a difficult and distressing time.

Dr Rachel Abbott
rachel.abbott@wales.nhs.uk


Mr Burhan Ben Karatas
excise-ctr@cardiff.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Cardiff and Vale University Health Board and funded by National Institute for Health and Care Research.



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: ISRCTN15382058

Or CPMS: 60084

Last updated 11 March 2026

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top