Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients' (WWW)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Betsie van Gaal, Radboud University
ClinicalTrials.gov Identifier:
NCT01187732
First received: August 23, 2010
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Skin Disease
Device: Washing without water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: WASHING WITHOUT WATER Cost-effectiveness of a Rapidly Spreading Nursing Intervention om Bedridden Patients'

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • the primary outcome is prevalence of care associated skin damage [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Skin damage is defined as intertrigo, dermatitis and/or other erythema on skin areas which were not exposed to pressure directly before observation.


Secondary Outcome Measures:
  • Patient and nurse satisfaction with bathing technique [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    • patient perceived discomfort during bathing
    • nurse perceived work load
    • observed bathing quality

  • Cost bathing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Bathing and skin damage associated costs will be calculated from the costs of bathing and skin care associated staff time and the materials used.


Estimated Enrollment: 576
Study Start Date: April 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Washing without water
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
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.
Other Names:
  • bag baths
  • disposable washing cloths
Active Comparator: Traditional soap and water bath
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
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.
Other Names:
  • bag baths
  • disposable washing cloths

Detailed Description:

RAPID IMPLEMENTATION of new interventions while cost-effectiveness and acceptability for patients and care providers are unclear, is never desirable. 'Washing without water' is such an intervention.

The traditional bed bath is executed by using tap water, towels, washcloths and soap. As an alternative, 'WASHING WITHOUT WATER' was recently introduced in the Netherlands. This concept consists of disposable washcloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion. 'WASHING WITHOUT WATER' can be used with all patients who need bathing assistance, especially when taking a shower or sitting in a hot tub is not possible.

However, while several claims are made about the positive effects of 'washing without water' as compared to traditional bathing, EVIDENCE IS LACKING. Also, 'washing without water' is CONTROVERSIAL. While some are eager to adopt the new concept, others see it as 'efficiency gone loose' and denying patients one of the most basic elements of care: a proper bath. This study therefore addresses the cost effectiveness of 'washing without water' in bedridden patients.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187732

Contacts
Contact: Betsie GI van Gaal, PhD +31 24 3619326 b.vangaal@iq.umcn.nl
Contact: Theo van Achterberg, PhD +31 24 3619529 t.vanachterberg@iq.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Betsie GI van Gaal, PhD    +31243619326    b.vangaal@iq.umcn.nl   
Principal Investigator: Betsie GI van Gaal, PhD         
Sponsors and Collaborators
Betsie van Gaal
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Chair: Theo van Achterberg, PhD Radboud University Nijmegen Medical Centre; IQ healthcare
  More Information

No publications provided

Responsible Party: Betsie van Gaal, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01187732     History of Changes
Other Study ID Numbers: 80-82310-97-1074
Study First Received: August 23, 2010
Last Updated: June 19, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
skin damage
intertrigo
dermatitis
erythema
aggression
body Wipes
soaps
no rinse
cost effectiveness
nursing home residents
nurse

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on August 20, 2014