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

University Ghent

Status: Terminated

Conditions: Incontinence-associated Dermatitis; Pressure Ulcer; Diaper Rash; Irritant Contact Dermatitis Due to Incontinence

Treatments: Other: water and pH neutral soap; Other: Wash wipes (3M)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02475512

B670201524231 (Other Identifier)

2015/0277

Details and patient eligibility

About

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.

Enrollment: 385 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• urinary incontinence, fecal incontinence or double incontinence
• depending on help for washing
• free of skin damage (without signs of pressure ulcers or IAD such as skin breakdown or redness)

Exclusion criteria

• not incontinent or minor incontinent (e.g. stress incontinence)
• urinary or fecal catheter
• use of incontinence wipes in the uro-genital area two weeks prior to the start of the study
• the use of a skin barrier product in the uro-genital area two weeks prior to screening
• presence of a bacterial/fungal infection in the uro-genital area

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups, including a placebo group

Wash wipes

Experimental group

Description:

Washing with water and soap (standard care) will be replaced with two wash wipes during 30 days: (1) daily total body wash (using 3M Cavilon Bathing and Cleansing wipes) and (2) Continence Care (using 3M Cavilon Continence Care Wipes). No other preventive barrier or hydration products will be allowed in the genital-anal region.

Treatment:

Other: Wash wipes (3M)

Standard care

Placebo Comparator group

Description:

Washing will be done using water and pH neutral soap. No other preventive barrier or hydration products will be allowed in the genital-anal region.

Treatment:

Other: water and pH neutral soap