Health Care UtilizationTApASNCT04002245
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 study testing antiseptic application in people with Health Care Utilization, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Utilization
- What is being tested?
- antiseptic application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2019to 19 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
- Nursing student (NS)
- Signed consent
- Major (18 years old and over)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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,
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.
Read the 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
- Being tested
- antiseptic application
- Keywords
- vascular access, skin antisepsis, cutaneous antisepsis
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiseptic applicationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Go back | Experimental | Application of a compress impregnated with alcoholic Betadine® by movement of return Receives: 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. Receives: Procedure: antiseptic application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of microorganisms
Average difference in the number of microorganisms between the initial and final samples.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start8 Apr 2019
- Primary completion19 Jun 2019
- Study completion19 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health Care UtilizationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yolène CARRE, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002245
- Sponsor's protocol ID
- CHUBX 2018/36
- Other IDs
- 2018-A02954-51
- Acronym
- TApAS
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32822683
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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,
- ClinicalTrials.gov ID
- NCT04002245
- Acronym / sponsor ID
- TApAS / CHUBX 2018/36
- Conditions
- Health Care Utilization
- Keywords
- vascular access, skin antisepsis, cutaneous antisepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 19 Jun 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Go back | Experimental | Procedure: antiseptic applicationApplication of a compress impregnated with alcoholic Betadine® by movement of return |
| Technique of snail | Experimental | Procedure: antiseptic applicationApplication 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy volunteer
- Nursing student (NS)
- Signed consent
- Major (18 years old and over)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiseptic applicationThe application of the antiseptic on the healthy and visibly clean skin of the bend of the elbow will be carried out for all participant | Procedure or surgery | Go back, Technique of snail |
Primary outcome
Number of microorganisms
Time frame: Day 1
Average difference in the number of microorganisms between the initial and final samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 32822683Carre 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolène CARRE principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antiseptic application in people with Health Care Utilization, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of microorganisms (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04002245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.