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,

NCT ID: NCT04002245

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2019-06-19

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.

Conditions

Health Care Utilization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Go back

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

Group Type: EXPERIMENTAL

antiseptic application

Intervention Type: PROCEDURE

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

Technique of snail

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.

Group Type: EXPERIMENTAL

antiseptic application

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yolène CARRE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

ISFI Pellegrin - CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2018/36

Identifier Type: -

Identifier Source: org_study_id