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,

Not Applicable

Completed

• Conditions: Health Care Utilization
• Interventions: Procedure: antiseptic application

• Registration Number: NCT04002245
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-04-08
• Status Verified: 2019-06
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technique of snail	antiseptic application	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.
Go back	antiseptic application	Application of a compress impregnated with alcoholic Betadine® by movement of return

Primary Outcome Measures

Name	Time	Method
Number of microorganisms	Day 1	Average difference in the number of microorganisms between the initial and final samples.

Trial Locations

Locations (1)

ISFI Pellegrin - CHU de Bordeaux; 🇫🇷 Bordeaux, France