NCT02984527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

November 29, 2016

Last Update Submit

October 15, 2018

Conditions

Intimate Hygiene

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

water and soap first day

ACTIVE COMPARATOR

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

Device: wet wipesDevice: water and soap

disposable wet wipes first day

ACTIVE COMPARATOR

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

Device: wet wipesDevice: water and soap

Interventions

wet wipesDEVICE

intimate hygiene with disposable wet wipes

disposable wet wipes first daywater and soap first day
water and soapDEVICE

Intimate hygiene with water and soap

disposable wet wipes first daywater and soap first day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who need intimate hygiene
  • Admitted for minimum two days
  • Understand oral information
  • And apple to sign written consent

You may not qualify if:

  • Diarrhea
  • Dementia
  • Dying

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Jutland, 7100, Denmark

Location

MeSH Terms

Interventions

Hydrotherapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Jette Primdahl, PhD

    Hospital of Southern Jutland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 7, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)