Traditional Bed Baths Versus Disposable Wet Wipes

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

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.

Study Overview

• Status: Completed
• Conditions: Intimate Hygiene
• Intervention / Treatment: Device: wet wipes; Device: water and soap

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

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Jutland
    • Aabenraa, Jutland, Denmark, 7100
      • Hospital of Southern Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: water and soap first day; Intimate hygiene performed with water and soap first day and disposable wet wipes second day	Device: wet wipes; intimate hygiene with disposable wet wipes; Device: water and soap; Intimate hygiene with water and soap
Active Comparator: disposable wet wipes first day; Intimate hygiene performed with wet wipes first day and water and soap second day	Device: wet wipes; intimate hygiene with disposable wet wipes; Device: water and soap; Intimate hygiene with water and soap

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Hospital of Southern Jutland
• Investigators: Study Chair: Jette Primdahl, PhD, Hospital of Southern Jutland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: SDUSF-2015-65/R1 - (205)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No