Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT02984527
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Traditional Bed Baths Versus Disposable Wet Wipes
Sponsor:
University of Southern Denmark
Organization:
Study Overview
Official Title:
Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: