None listed
Conditions
Brief summary
This study will investigate the effectiveness of two interventions to prevent surgical site infection after below-knee surgery for skin cancer in adults. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with a skin cancer below the knee which requires a complex surgical technique (flap or graft repair), and you are a patient at one of the participating centres in Queensland. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups. Participants allocated to the first group will be asked to take an oral tablet pre- and post-surgery, and use an antibacterial body wash prior to their surgery. Participants allocated to the second group will also be asked to take a pre- and post-surgery antibiotic dose and use a provided body wash prior to their surgery. Participants allocated to the third group will be asked to take an oral tablet pre- and post-surgery and use a provided body wash prior to their surgery. It is hoped this research will determine whether use of oral antibiotics with or without antibacterial body wash has any impact on the incidence of post-surgical skin infections in patients undergoing surgical removal of below the knee skin cancers. If one or both of these measures is found to be effective, a larger trial enrolling a greater number of participants may be undertaken.
Interventions
Treatment arms will be:
• Arm 1 – All patients will use an all-over chlorhexidine body wash (minimum 50ml of Chlorhexidine gluconate 4% w/v solution) the night before and morning of the surgery and receive placebo antibiotics as per those is arm 3 – Control.
• Arm 2 – Clindamycin: Patients will be administered 450mg of oral clindamycin 30-60 mins before surgery in the waiting room to enable monitoring for adverse reactions and an equal second dose at home 6hrs post-surgery Participants will per
Treatment arms will be: • Arm 1 – All patients will use an all-over chlorhexidine body wash (minimum 50ml of Chlorhexidine gluconate 4% w/v solution) the night before and morning of the surgery and receive placebo antibiotics as per those is arm 3 – Control. • Arm 2 – Clindamycin: Patients will be administered 450mg of oral clindamycin 30-60 mins before surgery in the waiting room to enable monitoring for adverse reactions and an equal second dose at home 6hrs post-surgery Participants will perform a placebo bacterial load reduction following the same protocol as in Arm 1. Participants will be asked to complete a treatment diary to monitor adherence to the intervention.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients presenting to recruiting skin cancer clinics for surgical management of skin cancer below the knee which requires a complex surgical technique (flap or graft repair).
Exclusion criteria
Allergy to clindamycin, chlorhexidine or mupirocin; existing skin infection; unable to provide informed consent; peripheral vascular disease; diabetes; current use of antibiotics; clinical indication for antibiotic treatment following excision (e.g. valvular heart disease).
Outcome results
None listed