EXCISE
Research type
Research Study
Full title
EXamining antibiotics for ulCerated skIn cancer Surgical Excision: a pragmatic, double-blinded clinical and cost effectiveness randomised controlled trial.
IRAS ID
1009425
Contact name
Rachel Abbott
Contact email
Sponsor organisation
Cardiff and Vale University Health Board (CAV UHB)
ISRCTN Number
ISRCTN15382058
Research summary
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 we do not know whether antibiotics reduce the risk of getting an infection. Using more antibiotics than is 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.
We want to know 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). We will see how many in each group develop wound infections. This will help us to decide whether antibiotics should be given to patients before skin surgery.
We will recruit 380 people with ulcerated skin cancers from UK NHS hospitals. 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, they will receive a photo booklet to help identify potential infections. We will telephone everyone between day 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 hospital if a wound infection is suspected, all will receive additional treatment if required. We will also ask how long it took to return to normal activity and the impact on dailyREC name
Wales REC 3
REC reference
25/WA/0196
Date of REC Opinion
4 Aug 2025
REC opinion
Further Information Favourable Opinion