A Pilot Study Efficiency of Techniques of 'Snail ' and 'Go-back' Application of an Alcoholic Antiseptic on Healthy Skin Before the Placement of a Intra-vascular Device, (TApAS)

University Hospital of Bordeaux

Status: Completed

Conditions: Health Care Utilization

Treatments: Procedure: antiseptic application

Study type: Interventional

Funder types: Other

Identifiers

NCT04002245

CHUBX 2018/36

Details and patient eligibility

About

Given the lack of scientific data on the effect of the antiseptic application technique on reducing the number of microorganisms present during application, this pilot study will provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study.

Full description

During their care, many patients benefit from invasive procedures. These treatments involve a break-in of the healthy skin which, without the application of preventive measures, can be at the origin of an infection starting from the micro-organisms present on the skin.

Cutaneous antisepsis, which objective is to reduce or even eliminate commensal and transient flora microorganisms, is an essential preventive measure during an invasive act on healthy skin. The choice of antiseptic most suitable in this context has been the subject of numerous publications and recommendations (including: French Society of Hospital Hygiene - SF2H- 2016). But there is no consensus on application technique.

In France, there is two application techniques : the "snail" and the "back and forth" techniques. These two techniques have never been compared in clinical trials. This study will bring preliminary evidence on empirical practices, in order to complement the recommendations of good antiseptic practices and ultimately reduce infections.

This brings us to the following question: what are the effects of the application of an alcoholic antiseptic by "back and forth" and "snail" techniques on healthy skin? We'll conduced a monocentric non-comparative, randomized, matched pilot study, to provide data on the initial level of microorganisms in this population of healthy volunteers and on the difference before and after antiseptic application according to both techniques. These data will be useful to then calculate the study size suitable for a formal comparative study between application techniques.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer
• Nursing student (NS)
• Signed consent
• Major (18 years old and over)

Exclusion criteria

• Allergy to the antiseptic used in the study
• Contamination visible at the bend of the elbow
• Impossibility to carry out the procedure on one of the arms

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Go back

Experimental group

Description:

Application of a compress impregnated with alcoholic Betadine® by movement of return

Treatment:

Procedure: antiseptic application

Technique of snail

Experimental group

Description:

Application of a compress impregnated with alcoholic Betadine into a single movement from the center towards the periphery and covering the end surface of followed by spontaneous drying time 30 seconds.

Treatment:

Procedure: antiseptic application