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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02954-51 | Other Identifier | ANSM |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Go back | Experimental | Application of a compress impregnated with alcoholic Betadine® by movement of return |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of microorganisms | Average difference in the number of microorganisms between the initial and final samples. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yolène CARRE | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISFI Pellegrin - CHU de Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32822683 | Result | 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. |
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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).
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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