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


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


METHODS
: A phase I dermatological study unit.


METHODS
Twenty healthy volunteers with intact skin.


METHODS
: 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.


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


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).


CONCLUSIONS
The results of this study indicate that polihexanide is a suitable alternative to chlorhexidine for skin and wound antisepsis.
B. Braun Medical Ltd, Sempach, Switzerland.
Dianne
D
Egli-Gany
Florian H H
FH
Brill
Matthias
M
Hintzpeter
Simone
S
Andrée
Viktoria
V
Pavel
D000328:Adult; D000891:Anti-Infective Agents, Local / Q000494:pharmacology*; D001645:Biguanides / Q000494:pharmacology*; D002710:Chlorhexidine / Q000494:pharmacology*; D015169:Colony Count, Microbial; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012867:Skin / Q000382:microbiology*; D017192:Skin Diseases, Bacterial / Q000517:prevention & control
D000891:Anti-Infective Agents, Local; D001645:Biguanides; C031233:polihexanide; D002710:Chlorhexidine