It's randomized and double blinded... what more do we want?

This issue of Journal of Neurosurgery: Pediatrics presents a randomized trial in which investigators have evaluated antimicrobial suture (AMS) in the prevention of shunt infection. The authors randomized 84 shunt procedures in 61 patients over 21 months. The surgeons and patients were blinded to treatment group. The groups appeared to be balanced with respect to shunt infection risk factors. Infection within 6 months of surgery occurred in 2 (4.3%) of 46 AMS procedures and in 8 (21%) of 38 control procedures. This study is a good first step. The authors should be applauded for conducting a double-blinded randomized trial, but the results need to be considered preliminary, and as they stand are not sufficient for a change in practice. As the authors state, they need further evaluation in a larger randomized trial.