Clinical trial NCT02984527: Traditional Bed Baths Versus Disposable Wet Wipes
Official title: Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Hygiene
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Hospital of Southern Jutland
First posted: 2016-12-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: microbiological counts on skin before and after interventions
timeFrame: two consecutive days
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
state: Jutland
Study officials:
affiliation: Hospital of Southern Jutland
name: Jette Primdahl, PhD
role: STUDY_CHAIR
References: