Intimate HygieneNCT02984527
Traditional Bed Baths Versus Disposable Wet Wipes
A study testing wet wipes and water and soap in people with Intimate Hygiene, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Hygiene
- What is being tested?
- wet wipes and water and soap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who need intimate hygiene
- Admitted for minimum two days
- Understand oral information
- And apple to sign written consent
Who cannot join
- Diarrhea
- Dementia
- Dying
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Intimate Hygiene
- Being tested
- wet wipes, water and soap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet wipesDevice
intimate hygiene with disposable wet wipes
water and soapDevice
Intimate hygiene with water and soap
| Study group | Role | What they receive |
|---|---|---|
| water and soap first day | Active comparator | Intimate hygiene performed with water and soap first day and disposable wet wipes second day Receives: Device: wet wipes; Device: water and soap |
| disposable wet wipes first day | Active comparator | Intimate hygiene performed with wet wipes first day and water and soap second day Receives: Device: wet wipes; Device: water and soap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intimate HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Southern Jutland
- Responsible party
- Principal investigator, Pia Lysdal Veje, University of Southern Denmark
- Investigators
- Jette Primdahl, PhD, Study chair, Hospital of Southern Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984527
- Sponsor's protocol ID
- SDUSF-2015-65/R1 - (205)
- Status last verified
- Oct 2018
- First submitted
- 29 Nov 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Skin Swaps From Traditional Bed Baths Versus Disposable Wet Wipes
- ClinicalTrials.gov ID
- NCT02984527
- Acronym / sponsor ID
- SDUSF-2015-65/R1 - (205)
- Conditions
- Intimate Hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Hospital of Southern Jutland
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| water and soap first day | Active comparator | Device: wet wipes, Device: water and soapIntimate hygiene performed with water and soap first day and disposable wet wipes second day |
| disposable wet wipes first day | Active comparator | Device: wet wipes, Device: water and soapIntimate hygiene performed with wet wipes first day and water and soap second day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who need intimate hygiene
- Admitted for minimum two days
- Understand oral information
- And apple to sign written consent
Key exclusion criteria (3 listed)
- Diarrhea
- Dementia
- Dying
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wet wipesintimate hygiene with disposable wet wipes | Device | disposable wet wipes first day, water and soap first day |
| water and soapIntimate hygiene with water and soap | Device | disposable wet wipes first day, water and soap first day |
Primary outcome
microbiological counts on skin before and after interventions
Time frame: two consecutive days
microbiological counts from skin swaps before and after washing with water and soap and before and after washing with disposable wipes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jette Primdahl, PhD study chair
Hospital of Southern Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wet wipes and water and soap in people with Intimate Hygiene, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiological counts on skin before and after interventions (time frame: two consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018; AzTrials last refreshed its copy on 31 Oct 2026.