Evaluation of the antiseptic efficacy and local tolerability of a polihexanide-based antiseptic on resident skin flora

Adv Skin Wound Care. 2012 Sep;25(9):404-8. doi: 10.1097/01.ASW.0000419405.52570.3e.

Abstract

Objective: The primary objective of this study was to compare the antimicrobial efficacy of polihexanide 0.02% and 0.04% with chlorhexidine 0.05% after 30 minutes of topical treatment on healthy intact skin.

Design: This study was performed as a double-blind, randomized, comparator-controlled, 3-arm, crossover study.

Setting: : A phase I dermatological study unit.

Participants: Twenty healthy volunteers with intact skin.

Interventions: : Test areas of 5 cm on the subjects' arms were treated with the investigational products using a polyurethane swab. Skin swabs were taken before and after treatment for quantitative microbial evaluation.

Main outcome measures: The main outcome measure was the log reduction factor of colony-forming units on the skin after 30 minutes of treatment.

Main results: No statistically significant difference was seen between both of the polihexanide test products (mean lgRF polihexanide 0.02%, 1.2251 [SD, 0.9399]; mean lgRF polihexanide 0.04%, 1.8991 [SD, 0.88]) and the comparator, chlorhexidine 0.05% (P > .1).

Conclusion: The results of this study indicate that polihexanide is a suitable alternative to chlorhexidine for skin and wound antisepsis.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Infective Agents, Local / pharmacology*
  • Biguanides / pharmacology*
  • Chlorhexidine / pharmacology*
  • Colony Count, Microbial
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Skin / microbiology*
  • Skin Diseases, Bacterial / prevention & control

Substances

  • Anti-Infective Agents, Local
  • Biguanides
  • polihexanide
  • Chlorhexidine