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,

NCT04002245 | Completed

• 2 other identifiers: CHUBX 2018/362018-A02954-51
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Utilization

Keywords

vascular access; skin antisepsis; cutaneous antisepsis

Outcome Measures

Primary Outcomes (1)

• Number of microorganisms

  Average difference in the number of microorganisms between the initial and final samples.

  Day 1

Study Arms (2)

Go back

EXPERIMENTAL

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

Procedure: antiseptic application

Technique of snail

EXPERIMENTAL

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

Interventions

antiseptic application 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

Go back; Technique of snail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

ISFI Pellegrin - CHU de Bordeaux

Bordeaux, 33000, France

Location

Related Publications (1)

• Carre Y, Moal B, Germain C, Frison E, Dubreuil M, Chansel C, Berger V, Boulestreau H, Lasheras-Bauduin A, Rogues AM. Randomized study of antiseptic application technique in healthy volunteers before vascular access insertion (TApAS trial). J Infect. 2020 Oct;81(4):532-539. doi: 10.1016/j.jinf.2020.08.022. Epub 2020 Aug 19.

  PMID: 32822683 RESULT

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Yolène CARRE

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: April 8, 2019
• Primary Completion: June 19, 2019
• Study Completion: June 19, 2019
• Last Updated: May 14, 2026

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)