Wound Infections Following Implant Removal

Rationale: Elective implant removal (IR) after fracture fixation is one of the most common procedures within the orthopaedic/trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other orthopaedic/ trauma surgical procedures.
Objective: The primary objective is to study the effectiveness of a single intravenous dose of 2g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. Secondary objectives are to study the cost-effectiveness of 2g of cefazolin preventing SSIs after IR, to study target-site antibiotic concentrations and tissue oxygenation, to identify underlying infections, and to identify independent predictors of SSI.
Study design: This is a multicenter, double-blind placebo controlled intervention study
Study population: Adult patients (>17 y/o) undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella.
Intervention (if applicable): The intervention group receives 2g of cefazolin as preoperative antibiotic prophylaxis, the control group receives a placebo injection.
Main study parameters/endpoints: the main study parameter is the proportion of patients with a SSI.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participating in this trial does not propose additional risk to the patient compared to current practice. Cefazolin has proved to be safe and effective as preoperative antibiotic prophylaxis in this dose. The burden is low for most patients as extra visits to the hospital are not required and questionnaires will take approximately 60 minutes in total. Additional measurements are only applicable to a small proportion of participants at the Amsterdam UMC. For these patients, blood samples will be obtained during surgery, under general or regional anaesthesia and include 3-4 serum samples, 2 target-site blood samples and 2 target-site soft tissue samples. Moreover patients will undergo continuous subcutaneous tissue oxygen tension measurements and measurements of haemoglobin oxygenation in the local microcirculation of the contralateral foot. No extra visits to the outpatient clinic are required when participating in the trial.

2gr of Cefazolin is effective as prophylaxis for surgical site infections following implant removal below the level of the knee.

Start inclusion: January 2020
End of follow up: April 2023 (until 6 months after last IR)
Analysis: May 2023 – July 2023
Implementation: August 2023 – October 2023

The intervention group receives 2g of cefazolin as preoperative antibiotic prophylaxis, the control group receives a placebo injection.