Safety and efficacy of the antiseptic chlorhexidine gluconate

Abstract

Chlorhexidine gluconate, an antiseptic for the skin, has recently been investigated in a series of clinical studies on its safety and efficacy. By using standard methods, Hibiclens, Hibitane tinted tincture and 0.5 per cent aqueous chlorhexidine gluconate were shown to have an extremely low potential for the production of irritation, allergic contact sensitization, photoallergic contact sensitization and phototoxicity. In the glove fluid test for efficacy against resident flora of the hand, Hibiclens produced log10 reductions over the control of 1.9398, 2.5371 and 2.6885 for test days 1, 2 and 5, respectively. Corresponding reductions for Hibitane tinted tincture were 3.6903, 4.0984 and 4.1253 and for the aqueous formulation, 1.5003, 1.5721 and 1.8692. In a transient flora skin contamination study, Serratia marcescens was applied at an average level of 6.8363 log10 organisms per milliliter to persons' hands, after which a 15 second Hibiclens hand wash was performed. Following five of these contaminations and hand washes, there was an over-all log10 reduction in recoverable Serratia of 3.8500. Counts were further determined after ten, 15, 20 and 25 contaminations and hand washes, resulting in corresponding reductions of 4.2649, 4.6661, 4.8501 and 5.1725, respectively. Chlorhexidine gluconate offers an alternative to available antiseptics for the skin. It has been shown to be a fast acting, broad spectrum antimicrobial agent, with an extremely low potential for eliciting dermal reactions.