Traditional Bed Baths Versus Disposable Wet Wipes

University of Southern Denmark (SDU)

Status: Completed

Conditions: Intimate Hygiene

Treatments: Device: water and soap; Device: wet wipes

Study type: Interventional

Funder types: Other

Identifiers

NCT02984527

SDUSF-2015-65/R1 - (205)

Details and patient eligibility

About

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.

Full 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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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72 participants in 2 patient groups

water and soap first day

Active Comparator group

Description:

Intimate hygiene performed with water and soap first day and disposable wet wipes second day

Treatment:

Device: wet wipes

Device: water and soap

disposable wet wipes first day

Active Comparator group

Description:

Intimate hygiene performed with wet wipes first day and water and soap second day

Treatment:

Device: wet wipes

Device: water and soap