Chlorhexidine Skin Prep Preparation And Study On Its Efficacy Safety

Purpose:According to"Standard Practice of Hospital Sterilization"issued by China MOH in 2002, ethanol based, iodine based and CHG based disinfector are all accepted to use for skin prep. Among them, ethanol based and iodine based disinfector have been regularly used in clinical, while CHG based disinfector has not widely used in China. The reason why is that we don't have a recommended concentration of CHG in skin prep despite lots of commercialized CHG solution. Moreover, there were still concerns and negative reports around efficacy and safety. To meet the requirement of clinic's development on skin sterilization and provide better medical service to sufferers, we produced a kind of new CHG skin prep and did plenty of tests to validate its efficacy and safety. Test:To identify the new CHG skin prep feasibility to promote in hospital, we did couples of study on efficacy and safety. After which, we delivered a report of them. For efficacy, we did "30 Seconds Time Kill Study","24 Hours Zone of Inhibition Test","7 Days Persistent Antimicrobial Efficacy Study-Lab test","7 Days Persistent Antimicrobial Performance Study-Human Skin Panel","28 Days Mildew Proof Study","3 Days Medical Dressing Adhesive to Human Skin Study". We sent samples to Chinese Center for Disease Control and Prevention to Toxicology Test and passed. Besides, we did plenty of studies to analysis the difference between new CHG skin prep with popular skin prep launched in market already, in order to deliver evidence-based data to clinical usage. Result : In"30-Second Time Kill Study", the Log10CFU/ml decrease after new CHG skin prep kill Escherichia coli, Staphylococcus aureus, Candida albicans and Pseudomonas aeruginosa are all more than 5,which is similar with AnErDian-I, AnErDian-II and 10% Providone Iodine while better than AnErDian-III and Dian'ErKang. In"24 Hours Zone of Inhibition Test", new CHG skin prep's inhibition performance is better than AnErDian-I, II, III, Dian'ErKang and 10% Providone Iodine. In"7 Days Persistent Antimicrobial Efficacy Study-Lab test", the Log10CFU/ml decrease after new CHG skin prep kill Staphylococcus aureus and Pseudomonas aeruginosa are more than 5, which is better than 10% Providone Iodine , AnErDian-I and DianErKang. In"7 Days Persistent Antimicrobial Performance Study-Human Skin Panel", we found new CHG skin prep still actively skill microbial after 7 days compared with baseline, which shows it's long-term capability to human skin prep. ;In"28 Days Mildew Proof Study", new CHG skin prep is better than 10% Providone Iodine, 75% Ethanol and marketing skin prep. In"3 Days Medical Dressing Adhesive to Human Skin Study", the dressing's adhesive to human skin after skin prep keeps well after 72 hours, significantly better than marketing products. The toxicology test report from CDC(Chinese Center for Disease Control and Prevention) which is authorized by MOH(Ministry of Health) is successful as well. As a result, we are confident that this new CHG skin prep is a kind of effective and safe skin prep which could be widely commercialized to China market.