Traditional Bed Baths Versus Disposable Wet Wipes

Study Overview
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Brief Summary
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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.

Detailed Description
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The study is a crossover clinical trial where the effect of two interventions is compared on the same subject. The two interventions are: Intimate hygiene with water and soap Intimate hygiene with prepackaged disposable wet wipes 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

Official Title
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Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes

Conditions
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Intimate Hygiene

Intervention / Treatment
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* Device: wet wipes
* Device: water and soap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who need intimate hygiene Admitted for minimum two days Understand oral information And apple to sign written consent Exclusion Criteria: Diarrhea Dementia Dying

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: water and soap first day<br>Intimate hygiene performed with water and soap first day and disposable wet wipes second day | Device: wet wipes<br>* intimate hygiene with disposable wet wipes<br>Device: water and soap<br>* Intimate hygiene with water and soap<br>|
| Active Comparator: disposable wet wipes first day<br>Intimate hygiene performed with wet wipes first day and water and soap second day | Device: wet wipes<br>* intimate hygiene with disposable wet wipes<br>Device: water and soap<br>* Intimate hygiene with water and soap<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | two consecutive days |