NCT04002245

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,

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Health Care Utilization

Interventions

Type	Name	Description
PROCEDURE	antiseptic application	The application of the antiseptic on the healthy and visibly clean skin of the bend of the elbow will be carried out for all participant

Timeline

• Start date: 2019-04-08
• Primary completion: 2019-06-19
• Completion: 2019-06-19
• First posted: 2019-06-28
• Last updated: 2019-07-02

Locations

1 site across 1 country: France