Efficacy and safety of a novel antimicrobial preoperative skin preparation.

ABSTRACT

OBJECTIVE: Alternatives to skin preparation with conventional preoperative antiseptics are required because of adverse reactions and the potential emergence of resistance. Here, we present 2 phase 2 studies of ZuraGard (ZG), a novel formulation of isopropyl alcohol and functional excipients developed for preoperative skin antisepsis. METHODS: Microbial skin flora on abdominal and inguinal sites in healthy volunteers were quantitatively assessed following application of ZG versus a negative control (ZV) and a chlorhexidine/alcohol preparation, Chloraprep (CP). In trial 1, ZG administered for both recommended and abbreviated application times was compared with CP and ZV via bacterial reductions at 10 minutes, and 6 hours, 12 hours, and 24 hours following application. In trial 2, the 10-minute postapplication responder rates (RRs) for ZG, participants with abdominal ≥2 log10 per cm2, and inguinal ≥3 log10 per cm2 reductions in colony-forming units (CFU) were compared to RRs of participants treated with CP. RESULTS: In trial 1, ZG at the recommended application time reduced mean bacterial counts by ~3.18 log10 CFU/cm2 and ~2.98 log10 CFU/cm2 at abdominal and inguinal sites, respectively. Qualitatively similar reductions were observed for the abbreviated ZG application time and all CP applications. Application of ZV was ineffective. In trial 2, 10-minute RRs for ZG and CP exceeded 90% at abdominal sites. At inguinal sites, RRs were 83.3% for ZG and 86.7% for CP. No skin irritation or other adverse events were observed. CONCLUSIONS: ZG matched CP efficacy under these experimental conditions with immediate and persistent microbial reductions, including abbreviated application times. Further clinical studies of this novel preoperative antiseptic are merited.