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Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly

NCT02475512 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2016-02-09

No results posted yet for this study

Summary

Incontinence is a widespread problem in all health care setting. One of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (IAD). IAD is a known risk factor of pressure ulcer development. Prevalence figures of IAD vary between 5.6% and 50%.

The primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of IAD. The second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. Other outcomes are the comfort and tolerance of both the nurses and participants.

In this Randomized Controlled Trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. In the experimental intervention, the participants will be washed with body wash wipes and genital wipes. In the control group, the subjects will receive traditional care. IAD as well as Pressure Ulcer prevalence will be monitored. Subjective and objective time measurements will be performed.

Conditions

  • Irritant Contact Dermatitis Due to Incontinence
  • Diaper Rash
  • Pressure Ulcer
  • Incontinence-associated Dermatitis

Interventions

OTHER

Wash wipes (3M)

OTHER

water and pH neutral soap

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • University Ghent

    lead OTHER

Principal Investigators

  • Dimitri Beeckman, PhD · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02475512 on ClinicalTrials.gov