Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2016-10-31
2018-02-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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water and soap first day
Intimate hygiene performed with water and soap first day and disposable wet wipes second day
wet wipes
intimate hygiene with disposable wet wipes
water and soap
Intimate hygiene with water and soap
disposable wet wipes first day
Intimate hygiene performed with wet wipes first day and water and soap second day
wet wipes
intimate hygiene with disposable wet wipes
water and soap
Intimate hygiene with water and soap
Interventions
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wet wipes
intimate hygiene with disposable wet wipes
water and soap
Intimate hygiene with water and soap
Eligibility Criteria
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Inclusion Criteria
* Admitted for minimum two days
* Understand oral information
* And apple to sign written consent
Exclusion Criteria
* Dementia
* Dying
18 Years
ALL
No
Sponsors
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Hospital of Southern Jutland
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Pia Lysdal Veje
PhD student
Principal Investigators
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Jette Primdahl, PhD
Role: STUDY_CHAIR
Hospital of Southern Jutland
Locations
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Hospital of Southern Jutland
Aabenraa, Jutland, Denmark
Countries
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Other Identifiers
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SDUSF-2015-65/R1 - (205)
Identifier Type: -
Identifier Source: org_study_id
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