A double-blind randomized controlled trial of the local application of vancomycin versus ampicillin powder into the operative field for thoracic and/or lumbar fusions

Abstract

OBJECTIVE Retrospective studies have reported that the local application of vancomycin (VCM) powder into the operative field decreases the incidence of surgical site infection (SSI) in thoracic and/or lumbar fusion. Authors of the present study prospectively evaluated the effects of VCM in patients undergoing thoracic and/or lumbar fusion. METHODS In this randomized double-blind trial, 230 patients undergoing thoracic and/or lumbar fusion were randomly assigned to the local administration of VCM (interventional group, 1 g) or ampicillin (AMP; control group, 1 g) into the surgical field. The primary outcome was SSI results within 1 year of surgery. RESULTS The trial was prematurely stopped according to predetermined rules. The results showed one superficial infection (0.9%, Staphylococcus aureus) and one deep infection (0.9%, S. aureus) in the VCM group and two superficial infections (1.8%, Staphylococcus epidermidis and culture negative) and one deep infection (0.9%, methicillin-resistant S. aureus) in the AMP group. No significant differences in infection rates were observed between the groups (p = 0.8). CONCLUSIONS This double-blind randomized controlled trial demonstrated that the local application of VCM or AMP powder into the operative field in short thoracic and/or lumbar fusion procedures resulted in a similar incidence of SSI. CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: class III. Clinical trial registration no.: UMIN000009377 (umin.ac.jp/ctr).