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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01187732
Other study ID # 80-82310-97-1074
Secondary ID
Status Completed
Phase N/A
First received August 23, 2010
Last updated April 24, 2017
Start date April 2011
Est. completion date November 2012

Study information

Verified date April 2017
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Netherlands Radboud university medical center Nijmegen Gelderland

Sponsors (2)

Lead Sponsor Collaborator
Betsie van Gaal ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patient and nurse satisfaction with bathing technique patient perceived discomfort during bathing
nurse perceived work load
observed bathing quality
6 weeks
Secondary Cost bathing Bathing and skin damage associated costs will be calculated from the costs of bathing and skin care associated staff time and the materials used. 6 weeks
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