Topical antibiotics in ankle fracture surgery (TAAFS) study
The use of local antibiotic delivery is not a new concept, with cement antibiotic beads, dissolvable antibiotic beads, and antibiotic gels all previously reported. Principally, local antibiotics can exceed the minimum inhibitory concentration (MIC) within the target area without inducing systemic toxicity as with systemic delivery modes, and can ideally approach or exceed the minimum bactericidal concentration (MBC).
The topical antibiotics in ankle fracture surgery (TAAFS) pilot study is a multi-centre, prospective, double-blinded, placebo control, randomized controlled trial comparing standard surgical fixation of ankle fractures with and without local topical antibiotics administered at the time of wound closure. We will test our hypothesis by randomizing one group of patients to receive 1g of topical vancomycin powder mixed with 160mg of gentamicin(80mg/2ml) which makes a 4ml solution. This is applied to the wound at the time of closure. The control group will receive a 4ml normal saline solution as the placebo control. Routine follow-up of patients will be completed as per usual standard of care.
The aims of this pilot study include determining the prevalence of both deep and superficial surgical site infection (SSI) according to the centre for disease control and prevention (CDC) definition as well as fracture related infection definition. Subgroup risk stratification analysis will also be performed to determine whether at risk populations are more benefited from topical antibiotic application. Patients will be followed up at 2 weeks, 6 weeks and 3 months. At 6 and 12 months, patients will receive a telephone call to determine whether there was any late infection and collect patient reported outcome measures (PROMs) data.
The Royal Brisbane & Women’s Hospital, Cairns Hospital and The Townsville University Hospital are the 3 pilot sites. The sample size for this pilot study will consist of 332 patients, spread across the 3 sites. The authors thank the Queensland Orthopaedic Research Fund for funding this pilot study and making this research idea possible.