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Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Rapid pre-operative preparation of the hand with persteril
Author:
Pazdiora, A. and Kubicek, V.
Year:
1967
Bibliographic source:
Vojenské Zdravotnické Listy, 1967, 36, (3), pp. 116-117

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
Determination of the number of microbes on the hands of the volunteers using Persteril and that of a control group before and after disinfection.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Peracetic acid
EC Number:
201-186-8
EC Name:
Peracetic acid
Cas Number:
79-21-0
Molecular formula:
C2H4O3
IUPAC Name:
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): Persteril
- Composition of test material, percentage of components: 40 % aqueous solution of PAA also containing acetic acid

Method

Type of population:
occupational
Details on study design:
Volunteers in this study were surgeons. The aim is to find an effective pre-operative disinfection procedure that does not damage the surgeon´s hand.
Persteril group: 20 volunteers washed their hands and forearms for 3 minutes in freshly prepared Persteril solution containing 0.2 % PAA using sterile sponges. Before mechanical impurities were removed from the skin by applying soap and water. The volunteers washed their fingers for 30 seconds in 10 mL of sterile broth before and after disinfecting the hand to exclude bacteriostatic action. Additionally, rinsing with tap water was performed. Subsequently, inoculation of 0.1 mL of broth on blood agar, incubation and counting of pathogenic microbes on plates were conducted.
Control group: 14 volunteers washed their hands with soap and water using brushes for 10 minutes and then for 5 minutes in a 1 % solution of Ajatin. The volunteers washed their fingers for 30 seconds in 10 mL of sterile broth containing 3 % Tween 80 before and after disinfecting the hand to exclude bacteriostatic action. Additionally, rinsing with tap water was performed. Subsequently, inoculation of 0.1 mL of broth on blood agar, incubation and counting of pathogenic microbes on plates were conducted.

Results and discussion

Results:
In case of small wounds in the skin contact with a Persteril dilution containing 0.2 % PAA caused occasionally a burning sensation.
The Persteril dilution containing 0.2 % PAA was well tolerated by the volunteers, only occasionally burning was reported. Also there occurred no post-operative complications.
The reduction of microbe count was 97.3 % in the Persteril (PAA) group and 72.7 % in the Ajatin control group.
It was further found that during an hour-long operation the microbe count on the volunteers´ hands is trebled after using Ajatin and quadrupled after disinfection in PAA showing that neither 0.2 % PAA nor 1 % Ajatin have a residual effect. An important feature of PAA to eradicate pathogenic staphylococci completely could be observed in this study.

Applicant's summary and conclusion

Conclusions:
PAA does not have a residual effect. Solutions of PAA with concentrations of 0.2 % do not damage the skin.
Executive summary:

The study authors investigated the use of the disinfectant Persteril as a dilution containing 0.2 % PAA for disinfecting the hands of an operating team.

The Persteril dilution containing 0.2 % PAA was well tolerated by the volunteers. The concentration of 0.2 % PAA is sufficient for eradication of pyogenic staphylococci and 97 % reduction of residual flora on the hand within 3 minutes.

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