ZuraGard, a novel preoperative skin antiseptic, was shown to be effective in reducing bacterial counts on the skin of healthy volunteers in two phase 2 trials, performing comparably to the standard antiseptic ChloraPrep, researchers reported.
Currently, ChloraPrep (Becton Dickenson) — 2% chlorhexidine gluconate (CHG) with 70% isopropyl alcohol — is “one of the most widely used preoperative topical skin preparations” in the United States, noted Christopher J. Crnich, MD, PhD, chief of medicine and hospital epidemiologist at the William S. Middleton Memorial Veterans Hospital and an associate professor of medicine at the University of Wisconsin School of Medicine and Public Health, and colleagues.
However, concerns about resistance as well as serious allergic reactions have led researchers to look for alternative methods to CHG-containing preoperative skin antiseptics, according to the authors.
“We evaluated the antimicrobial efficacy and basic safety profile of a newly developed topical preoperative skin antiseptic ZuraGard (Zurex Pharma), which contains isopropyl alcohol as an active ingredient, as well as the functional excipients citric acid, alkyl para-hydroxybenzoates, methylene blue (as a colorant), and purified water,” Crnich and colleagues wrote.
The findings are from two phase 2 studies that enrolled and randomly assigned 96 healthy participants to test ZuraGard against a negative control and ChloraPrep.
In the first trial, ZuraGard was applied to abdominal and inguinal sites in healthy volunteers for the recommended application times (2-minute inguinal scrub, 30-second abdominal scrub) and abbreviated application times (1-minute inguinal scrub, 15-second abdominal scrub) compared with the negative control and standard ChloraPrep application.
The researchers reported that after applying ZuraGard for the recommended time, mean bacterial counts were reduced by approximately 3.18 log10 colony-forming units (CFU)/cm2 at abdominal sites and by approximately 2.98 log10 CFU/cm2 at inguinal sites. They reported qualitatively similar reductions for the abbreviated ZuraGard application time and all ChloraPrep applications, and that the negative control application was ineffective.
The second trial was conducted without a negative control. In it, 10-minute postapplication responder rates for ZuraGard were compared with the responder rates of participants treated with ChloraPrep, with a primary endpoint objective of a 70% responder rate.
At abdominal sites, the 10-minute responder rate for both ZuraGard and ChloraPrep exceeded 90%. At inguinal sites, the responder rate for ZuraGard was 83.3% and for ChloraPrep was 86.7%.
“Perhaps most notably, [ZuraGard] achieved targeted 10-minute postapplication microbial reductions regardless of whether a 1- or 2-minute application time was employed at inguinal sites or a 15- or 30-second application time was employed at abdominal sites,” Crnich and colleagues wrote. “The reductions in cutaneous bacterial counts following application of [ZuraGard] were sustained for up to 24 hours, and no skin irritation was observed. These findings may have important practical significance because shorter application times have been correlated with higher levels of staff adherence to surgical site preparation protocols in at least 1 study.”
The researchers said the phase 2 results “strongly support the need for continued diversification of our topical antiseptic armamentarium” and “justify larger-scale studies to examine the effectiveness and safety of this product in randomized clinical trials and in more diverse patient populations.” – by Marley Ghizzone
Disclosures: The authors report no relevant financial disclosures.