Antibiotic treatment for the prevention of surgical site infection in participants receiving ulcerated skin cancer excision Infections and Infestations
Conditions
Interventions
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 ana
Sponsors
Cardiff and Vale University Health Board
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with surgical site infection within 30 days post-randomisation. Participants will be contacted by a research nurse at days 5-10, 15-20 and day 30 (+/- 7 Days) to ask about their wound and signs of infection. If the participant or research nurse has any concerns, they will be asked to come to the participating centre to confirm surgical site infection using CDC criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures 1. The number of participants with adverse events within 30 days of surgery, defined using the Medical Dictionary for Regulatory Activities 2. Antibiotic resistance to clinically relevant antibiotics, and measured in isolates from participants’ wounds at diagnosis of SSI and after 7 days if no response to treatment. This will be assessed by a central microbiology laboratory (Public Health Wales) 3. Health-related QoL measured using the EQ-5D-5L questionnaire at baseline, 30 days and 3 months 4. Time to return to normal activity/work measured using ‘Time to return to normal activity/work’ case report form (CRF) at 30 days and 3 months 5. Resource use (related to wound complications, including SSI) and cost of hospital visits/stays, measured using a ‘resource use measure’ CRF at 30 days and 3 months 6. Qualitative process evaluation assessing implementation and acceptability of oral antibiotics, including facilitators and barriers, measured using qualitative interviews at 30 days 7. Feasibility of ‘Selfi-wound’ photos measured using the number of participants who were able to successfully take and transmit an image of their wound via the online system at days 5-10 8. Validation of WHQ remote use for SSI assessment measured using a Study within A Trial (SWAT) at 30 days Tertiary outcome Qualitative process evaluation exploring participant wound burden measured using qualitative interviews at 30 days | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactBurhan Ben Karatas
Outcome results
None listed