An interventional study of wet wipes and water and soap in Intimate Hygiene, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Supportive care
The Purpose of the study is to compare the effectiveness on microbiological counts from skin swaps after wash with water and soap or wet wipes.
The study is a crossover clinical trial where the effect of two interventions is compared on the same subject.
The two interventions are:
Null hypothesis: Same effectiveness to reduce microbiological counts on skin
Alternative hypothesis: Significant different effectiveness to reduce microbiological counts on skin
Each individual receives the two interventions in random order. The effect of the interventions on microbiological counts on the patients skin is evaluated on the same patient.
A crossover trial requires half the number of participants and reduces confounding factors.
All participants receive a sequence of the two different interventions. But there is a sufficient gab between the two interventions to ensure a washout period and avoid a crossover effect. In this study this is 12-24 hours.
The study uses block randomization, without intra block correlation to achieve allocation balance over time.
Furthermore it may prevent some predictable allocation.
Microbiological sampling with moistened swaps and aseptic techniques, sterile equipment and sterile recovery medium (Stewarts Medium) are used to obtain skin samples from the patients before and after intimate hygiene with water and soap and wet wipes.
Differences in microbiological skin counts will be compared (delta values) before and after the two interventions and between interventions.
Data will be blinded during microbiological count and statistical analyses.
Analyses:
Data are structured in CASTOR and will be stored in a secure Team Collaboration Software Tool (SharePoint).
Descriptive analysis including mean, median, confidence interval, standard deviation, and standard error.
Statistical analyses will be performed using STATA. Test of differences will be performed by simple t- test or Wilcoxon sign rank test, depending on the distribution of the data. A multiple regression analysis including possible confounders will be considered.
Inclusion of 68 patients
University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intimate hygiene performed with water and soap first day and disposable wet wipes second day
Device: wet wipes · Device: water and soap
Intimate hygiene performed with wet wipes first day and water and soap second day
Device: wet wipes · Device: water and soap
intimate hygiene with disposable wet wipes
Intimate hygiene with water and soap
microbiological counts on skin before and after interventions
microbiological counts from skin swaps before and after washing with water and soap and before and after washing with disposable wipes
Time frame: two consecutive days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of Southern Denmark