Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02984527 |
| Other study ID # |
SDUSF-2015-65/R1 - (205) |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
February 2018 |
Study information
| Verified date |
October 2018 |
| Source |
University of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
