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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)

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ClinicalTrials.gov Identifier: NCT04002245
Recruitment Status : Completed
First Posted : June 28, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Health Care Utilization Procedure: antiseptic application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: From the paper randomisation list that has been communicated to him, he learns the application technique to be performed on each of the two arms (right or left).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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,
Actual Study Start Date : April 8, 2019
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019

Arm Intervention/treatment
Experimental: Go back
Application of a compress impregnated with alcoholic Betadine® by movement of return
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

Experimental: 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.
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




Primary Outcome Measures :
  1. Number of microorganisms [ Time Frame: Day 1 ]
    Average difference in the number of microorganisms between the initial and final samples.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002245


Locations
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France
ISFI Pellegrin - CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Yolène CARRE University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04002245    
Other Study ID Numbers: CHUBX 2018/36
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
vascular access
skin antisepsis
cutaneous antisepsis
Additional relevant MeSH terms:
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Anti-Infective Agents, Local
Anti-Infective Agents