EXamining antibiotics for ulCerated skIn cancer Surgical Excision (EXCISE): a pragmatic, double-blinded clinical and cost effectiveness randomised controlled trial.
Antibiotic treatment for the prevention of surgical site infection in participants receiving ulcerated skin cancer excision
To investigate the efficacy of a single pre-operative 1g dose of oral flucloxacillin in preventing SSI within 30 days in adults undergoing surgical excision of an ulcerated skin cancer under local anaesthetic with planned wound closure. Participants will receive either Intervention: pre-operative oral flucloxacillin 1g (500mg x 2) in addition to standard clinical care, or Comparator: no antibiotic (placebo) and standard clinical care. Outcomes will be assessed at baseline, 5-10 days, 15-20 days, 30 days and at 3 months post randomisation. Data will be collected by the research nurses either in person or via telephone, email or post, or review of patient records, and entered in electronic format on the EXCISE database. Patients will be contacted at follow-up points, and if (up until 30 days) there is concern of a wound infection, they will be asked to return to their recruiting site for a face-to-face assessment of their wound. Participants will be randomised between the two groups (190 participants per group) with a 1:1 allocation ratio. Randomisation will occur electronically prior to surgery. Allocations will be minimised (with a random element) by SSI risk associated with reconstruction method (primary closure, skin graft or local skin flap) and anatomical site (below knee or other anatomical site) and stratified by the recruitment site. A computerised web-based remote randomisation system will be used. The Trial Manager will also be notified that a participant has been randomised via an automated email alert mechanism to the EXCISE email inbox. This system will be maintained by the Cardiff Centre for Trials Research (CTR) and accessed by the local investigator or site staff delegated to do so, following consent and completion of baseline assessments. In the event the online randomisation system is unavailable at the site, or the site has problems accessing the online website, participants will not be disadvantaged by having their surgery delayed and will be e
1. Adult patients (≥16 years) with a clinically ulcerated suspected skin cancer (at any body site) listed for excision under local anaesthetic with planned wound closure by any secondary care speciality. 2. First time in the EXCISE trial. 3. Ability to provide Informed Consent (by participant or through a participant’s personal legal representative).
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.