EXCISE

EXamining antibiotics for ulCerated skIn cancer Surgical Excision: a pragmatic, double-blinded clinical and cost effectiveness randomised controlled trial.

Background

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.

Study aims

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.

Previous research

We asked UK doctors who remove skin cancers (through an online survey) if they prescribe antibiotics, and if so, what they give and for how long. 50% said they routinely prescribe antibiotics, while 50% never prescribe antibiotics. We also carried out a study which found that a third of patients developed a wound infection after removal of their ulcerated skin cancer.

Study aims

We will recruit 380 people with ulcerated skin cancers from UK NHS hospitals. Immediately before surgery, participants will be randomly allocated by a computer to have a one-off dose of antibiotic tablets 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 clinic 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 daily life at 30 days and 3 months after surgery. At the end of the trial, we will know how many developed a wound infection and whether taking antibiotic tablets before surgery reduces the risk of wound infection.