In the JournalsPerspective

Novel skin antiseptic ZuraGard matches efficacy of ChloraPrep

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.

 

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.

 

    Perspective
    Gitanjali Pai

    Gitanjali Pai

    The use of antiseptic agents for hand hygiene and skin decolonization before invasive procedures is an integral step in the risk reduction and prevention of surgical site infections (SSIs). SSIs carry not only a significant morbidity and mortality burden but also translate into colossal increases in health care costs in an already financially strained health system. With the extensive use of CHG-based health care products including antiseptics, the looming resistance to CHG is a concern that should be on our radar, especially in the light of worsening antibiotic resistance across the board. Adaptive bacterial responses to CHG have been noted, especially among nosocomial pathogens with a  known potential for severe resistance to antibiotics. Any strategies to decrease this avoidable selection pressure to CHG (and hence the subsequent clinical implications) must be researched. Also, allergic reactions including IgE-mediated reactions have been reported. Thus, it is prudent and imperative to explore options beyond CHG for antisepsis, including preoperative skin preparation. The results of this study by Crnich and colleagues are encouraging. The sustained reduction (for up to 24 hours) in cutaneous bacterial counts following application of ZuraGuard, a novel antiseptic agent, as described in this study, is promising. This study paves the way for further large-scale studies in the quest for alternative agents to CHG for presurgical skin preparation.

    • Gitanjali Pai, MD, AAHIVS
    • Infectious Disease News Editorial Board member
      Memorial Hospital
      Stilwell, Oklahoma

    Disclosures: Pai reports serving on advisory boards for Abbvie and Gilead Sciences.