A 3-in-1 perineal care washcloth impregnated with dimethicone 3% versus water and pH neutral soap to prevent and treat incontinence-associated dermatitis: a randomized, controlled clinical trial.

PURPOSE: We compared the effectiveness of a 3-in-1 perineal care washcloth versus standard of care (water and pH neutral soap) to prevent and treat incontinence-associated dermatitis (IAD). The product under study was a soft, premoistened washcloth, including a 3% dimethicone formula, with cleansing, moisturizing, and barrier protection properties.
DESIGN: Randomized, controlled clinical trial. SUBJECTS AND
SETTING: The study sample comprised a random sample of 11 nursing home wards (6 experimental and 5 control) in a convenience sample of 4 nursing homes in Belgium. The sample included nursing home residents at risk for and/or affected by IAD defined as incontinent of urine, feces, urine/feces, and/or having erythema of the perineal skin (not caused by pressure/shear), and/or having an edematous skin in the genital area.
METHODS: Participants in the experimental group were treated according to a standardized protocol, including the use of a 3-in-1 perineal care washcloth impregnated with a 3% dimethicone skin protectant. Participants in the control group received perineal skin care with water and pH neutral soap, the standard of care in Belgian nursing homes. The study period was 120 days. Data were collected between February and May 2010. Incontinence-associated dermatitis prevalence and severity were assessed using the IAD Skin Condition Assessment Tool. The surface (cm), redness, and depth of the perineal lesion were assessed daily by the nurses. This tool generates a cumulative severity score (maximum score = 10) based on area of skin affected, degree of redness, and depth of erosion.
RESULTS: Four hundred sixty-four nursing home residents were assessed and 32.9% (n = 141) met the criteria for inclusion, including 73 subjects in the experimental group and 68 in the control group. Baseline IAD prevalence was comparable in both groups (experimental: 22.3% vs control: 22.8%, P = .76). Baseline IAD severity was 6.9/10 in the experimental group and 7.3/10 in the control group. A significant intervention effect on IAD prevalence was found (experimental: 8.1% vs control: 27.1%, F = 3.1, P = .003). A nonsignificant effect on IAD severity could be determined (experimental: 3.8/10 vs control: 6.9/10, F = 0.8, P = .06).
CONCLUSION: The use of a 3-in-1 washcloth, impregnated with a 3% dimethicone formula, resulted in a significantly reduced prevalence of IAD and a trend toward less severe lesions. These findings provide indicative evidence for the use of 3-in-1 perineal care washcloth as an effective intervention against the use of water and a pH neutral soap to prevent and/or treat IAD.

RCT Entities:   Population Interventions Outcomes