Antimicrobial suture wound closure for cerebrospinal fluid shunt surgery: a prospective, double-blinded, randomized controlled trial.

OBJECT: Implantation of cerebrospinal fluid (CSF) shunting devices is associated with a 5-15% risk of infection as cited in contemporary pediatric neurosurgical literature. Shunt infections typically require complete removal of the device and prolonged antibiotic treatment followed by shunt replacement. Moreover, shunt infections are commonly associated with prolonged hospital stays, potential comorbidity, and the increased risk of neurological compromise due to ventriculitis or surgical complications. The authors prospectively evaluated the incidence of CSF shunt infection following shunt procedures performed using either antimicrobial suture (AMS) or conventional suture.
METHODS: In a single-center, prospective, double-blinded, randomized controlled trial, the authors enrolled 61 patients, among whom 84 CSF shunt procedures were performed over 21 months. Randomization to the study (AMS) or control (placebo) group was stratified to minimize the effect of known shunt infection risk factors on the findings. Antibacterial shunt components were not used. The primary outcome measure was the incidence of shunt infection within 6 months of surgery.
RESULTS: The shunt infection rate in the study group was 2 (4.3%) of 46 procedures and 8 (21%) of 38 procedures in the control group (p = 0.038). There were no statistically significant differences in shunt infection risk factors between the groups (procedure type and time, age < 6 months, weight < 4 kg, recent history of shunt infection). No suture-related adverse events were reported in either group.
CONCLUSIONS: These results support the suggestion that the use of AMS for CSF shunt surgery wound closure is safe, effective, and may be associated with a reduced risk of postoperative shunt infection. A larger randomized controlled trial is needed to confirm this association.

RCT Entities:   Population Interventions Outcomes