NCT01187732

Brief Summary

The purpose of this study is to compare the traditional bed bath with 'washing without water' on

  • 1\) effects on skin integrity
  • 2\) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional bed baths. Bathing regimens are continued for six weeks. Whereas effects on skin damage are not likely to be specific for setting, these results can be generalized to other patient groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

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

First Submitted

Initial submission to the registry

August 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

August 23, 2010

Last Update Submit

April 24, 2017

Conditions

Skin Disease

Keywords

skin damageintertrigodermatitiserythemaaggressionbody Wipessoapsno rinsecost effectivenessnursing home residentsnurse

Outcome Measures

Primary Outcomes (1)

  • the primary outcome is prevalence of care associated skin damage

    Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.

    6 weeks

Secondary Outcomes (2)

  • Patient and nurse satisfaction with bathing technique

    6 weeks

  • Cost bathing

    6 weeks

Study Arms (2)

Washing without water

EXPERIMENTAL

The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.

Device: Washing without water

Traditional soap and water bath

ACTIVE COMPARATOR

The control intervention is the traditional bathing assistance as performed in care dependent patients by using tap water, a bowl, towels, washcloths and soap.

Device: Washing without water

Interventions

Washing without waterDEVICE

The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.

Also known as: bag baths, disposable washing cloths
Traditional soap and water bathWashing without water

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • long stay psychogeriatric nursing home residents
  • long stay somatic nursing home residents
  • randomly selected nurses from the participating nursing home wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

  • Schoonhoven L, van Gaal BG, Teerenstra S, Adang E, van der Vleuten C, van Achterberg T. Cost-consequence analysis of "washing without water" for nursing home residents: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):112-20. doi: 10.1016/j.ijnurstu.2014.08.001. Epub 2014 Aug 10.

    PMID: 25173772DERIVED

MeSH Terms

Conditions

Skin DiseasesIntertrigoDermatitisErythemaAggression

Interventions

Therapeutic IrrigationHydrotherapy

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin Diseases, EczematousSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • Theo van Achterberg, PhD

    Radboud university medical center; IQ healthcare

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 23, 2010

First Posted

August 24, 2010

Study Start

April 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 25, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)