Evaluation with a focus on both the antimicrobial efficacy and cumulative skin irritation potential of chlorhexidine gluconate alcohol-containing preoperative skin preparations

摘要

Background: Important characteristics for ideal skin preparations include long-lasting antimicrobial efficacy and low potential for skin irritation. Methods: A total of 55 healthy adult subjects were enrolled to evaluate the antimicrobial effects of 3 test formulations applied to inguinal, abdominal, and antecubital sites at post-treatment time points of 30 seconds, 72 hours, and 7 days. To investigate skin irritation potential, the 3 formulations were tested in a 21-day repeat-insult patch test conducted on the skin of the backs of 23 healthy subjects. Results: The mean log10 reduction (MLR) at 7 days post-treatment produced by a 79% vol/vol ethanol containing 1% wt/vol chlorhexidine gluconate (1% CHG-EtOH) applied to abdominal sites was significantly superior to that produced by a 10% povidone-iodine solution (2.45 MLR vs 0.90 MLR; P .05). The 1% CHG-EtOH and a 70% vol/vol isopropanol containing 2% wt/vol CHG (2% CHG-IPA) provided statistically equivalent persistence at 72 hours and 7 days post-treatment. The 1% CHG-EtOH had less skin irritation poetntial than the 2% CHG-IPA and the 10% povidone-iodine solution, although the differences were not statistically significant (P .05). Conclusion: Considering its persistent effect and low skin irritation potential, the 1% CHG-EtOH preparation is expected to perform well in surgical site preparation to reduce the risk of surgery- and catheter-related bloodstream infection.