Abstract
BackgroundElective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) 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 (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures.MethodsThis is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups.DiscussionIf 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella.Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284
Highlights
MethodsThis is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella
Elective implant removal (IR) after fracture fixation is one of the most common procedures within trauma surgery
In the intervention group we aim for a 50% reduction to 7.45%, based on the Dutch Trauma Trial [24], who showed a reduction of surgical site infection (SSI) of over 50% in a large cohort of 2195 patients with fractures of the extremity
Summary
This is a multicenter, randomized double-blind placebo controlled intervention trial with a superiority design, comparing 2 g of cefazolin as antibiotic prophylaxis to placebo with a 1:1 allocation ratio. Combining the number of deep SSIs of the WIFI-1 trial and an RCT by Dong et al [25] leads to a mean of 0.85% deep SSIs with cefazolin and 4.15% deep SSIs without To detect this difference with a chi-square test with 80% power and a two-sided alpha of 0.05, 348 patients per group are required (696 in total). In the absence of data for a reliable sample size calculation for the antibiotic concentration measurements we will conduct of a pilot study using 40 participants (around 20 per group) This should be sufficient to estimate the pharmacokinetic (PK) parameters; clearance and volume of distribution, the mean value, and its interindividual variability. Surgeons are asked by the coordinating investigator/ project leader to check whether patients are included in the trial during the pre-operative assessment a day prior to surgery. The funding party will be mentioned on all publications of primary/secondary results of the trial
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