RecruitingPhase 1ACTRN12624000076572

Clindamycin and bacterial load reduction as prophylaxis for surgical site infection after below-knee flap and graft procedures: a trial protocol.

Clindamycin and bacterial load reduction as prophylaxis for surgical site infection after below-knee flap and graft procedures in patients requiring surgical management of skin cancer below the knee: a trial protocol.

Sponsor

James Cook University

Enrollment

155 participants

Start Date

Apr 10, 2024

Study Type

Interventional

Conditions

Skin Cancer

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This trial is testing two strategies to reduce the risk of skin infection after surgery for skin cancer below the knee. Surgery in this area — particularly when a flap or graft technique is needed to close the wound — has a relatively high rate of post-surgical infection compared with other parts of the body. The two interventions being tested are oral antibiotics (clindamycin) taken around the time of surgery, and an antibacterial body wash used before the procedure. Participants will be randomly assigned to one of three groups: antibiotics with or without antibacterial wash versus wash alone (with placebo tablet). Researchers will then track wound healing and infection rates over the weeks following surgery. If one or both strategies are found to be effective, the findings will inform a larger trial and potentially change standard surgical practice for skin cancer patients. You may be eligible if you are 18 or older, have been diagnosed with a skin cancer below the knee that requires a flap or graft repair, and are being treated at one of the participating Queensland skin cancer clinics. You are not eligible if you have an allergy to clindamycin, chlorhexidine, or mupirocin, have an existing skin infection, peripheral vascular disease, diabetes, or are currently taking antibiotics.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 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.