Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults

Graham, Tanya, Beeckman, Dimitri, Kottner, Jan, Fader, Mandy, Fiorentino, Francesca, Fitzpatrick, Joanne M, Gray, Mikel, Harris, Ruth G., Sooriah, Sangeeta, Wallace, Sheila A., Worsley, Peter R. and Woodward, Sue (2025) Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults. The Cochrane database of systematic reviews, 7 (7), CD011627, [CD011627]. (doi:10.1002/14651858.CD011627.pub3).

Abstract

Background: incontinence-associated dermatitis (IAD) is a common skin problem in adults with urinary incontinence, faecal incontinence, or both. Prevention involves skin care interventions such as skin cleansing and the application of skin protectants/barriers (leave-on products).

Objectives: to assess the effects of skin care cleansers, leave-on products, and procedures for preventing incontinence-associated dermatitis in adults.

Search methods: on 29 April 2024, we searched the Cochrane Incontinence Specialised Register - which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, and WHO ICTRP - and hand-searched journals and conference proceedings. We searched reference lists of included studies to identify additional studies.

Selection criteria: we selected randomised controlled trials (RCTs) and quasi-RCTs conducted in any healthcare setting and involving participants aged over 18 years without IAD at baseline. We included trials comparing the effectiveness of skin cleansing interventions and leave-on products or combinations of interventions/leave-on products.

Data collection and analysis: three review authors independently screened the titles, abstracts, and full-text articles. Four review authors independently extracted data and assessed risk of bias. Data from studies not published in English were translated and extracted by volunteers from Cochrane Engage and the review authors' networks. Primary outcomes were: number of participants with IAD and adverse effects related to the intervention (pain, skin rash, itching, and other serious adverse effects). Secondary outcomes were: number of participants satisfied with skin care products or procedures, adherence to the protocol throughout the intervention, and quality of life (condition-specific or generic). We used GRADE to assess the certainty of the evidence.

Main results: we included 15 trials with 1020 participants in a qualitative synthesis (41 participants from nursing homes; 65 from both care homes and hospital, and 914 from hospital settings). Participants had urinary incontinence, faecal incontinence, or both. Thirteen trials had small sample sizes and two trials had 180 and 174 participants. Six trials assessed outcomes in the short term (≤ 7 days), four in the medium term (8 days-1 month), and one in the long term (> 1 month-3 months). In the remaining studies, the timing of assessment was unclear. The overall risk of bias in the included studies was high. Substantial heterogeneity (in study populations, skin care products, skin care procedures, outcomes, and measurement tools) precluded meta-analysis. Three trials compared skin cleansing interventions, and five trials compared leave-on products or a combination of leave-on products. Seven trials compared a combination of skin cleansers and leave-on products. Number of participants with incontinence-associated dermatitis Three trials compared a skin cleanser with soap and water. One provided evidence that using a foam cleanser might be more effective than soap and water for preventing IAD (RR 0.35, 95% CI 0.14 to 0.85; 65 participants; very low-certainty evidence), while another found little or no difference in effectiveness between a disposable washcloth containing 3% dimethicone and soap and water (RR 0.14, 95% CI 0.01 to 2.28; 12 participants; very low-certainty evidence). The third trial reported lower erythema scores with a no-rinse skin cleanser compared with soap and water, but we were unable to analyse these data. In trials evaluating combinations of skin cleansers and leave-on products versus skin cleansing alone, one suggested the combined treatment may be more effective for preventing IAD (RR 0.03, 95% CI 0.00 to 0.53; 180 participants; very low certainty of evidence), and the other showed little to no difference between interventions (RR 0.71, 95% CI 0.14 to 3.68; 31 participants; very low-certainty evidence). Two studies showed little to no difference between a combination of leave-on products versus a single product (RR 0.85, 95% CI 0.36 to 2.02; 74 participants; very low-certainty evidence); (RR 0.25, 95% CI 0.03 to 1.86; 20 participants; very low-certainty evidence). In general, we cannot draw meaningful conclusions about the effectiveness of the tested interventions in preventing IAD because of the very low certainty of the evidence for all comparisons.

Adverse effects: pain. One trial found that fewer people using a combination of skin cleansing and a leave-on product experienced pain compared with those receiving cleansing without a leave-on product (RR 0.33, 95% CI 0.09 to 1.19; 180 participants; low-certainty evidence), and one trial found that fewer people using a no-rinse skin cleanser plus a skin cream developed pain compared with those using soap and water followed by a lotion (RR 0.58, 95% CI 0.19 to 1.74; 31 participants; low-certainty evidence). However, our analyses of these two comparisons suggest there may be little to no difference between the tested interventions in terms of associated pain.

Adverse effects: itching. One trial found that skin cleansing and a leave-on product may be less frequently associated with itching compared with a conventional skin care regimen with no leave-on product (RR 0.04, 95% CI 0.01 to 0.29; 180 participants; low-certainty evidence)

Authors' conclusions: we found limited evidence, of low and very low certainty, on the effectiveness of interventions for preventing IAD in adults. Consequently, it is unclear whether any skin cleanser or leave-on product, used alone or in combination, performs better than any other. There is some very uncertain evidence that using a skin cleanser may be better at preventing IAD than soap and water, and that using a combination of a skin cleanser with a leave-on product may be better at preventing IAD than using a skin cleanser alone. There is a need for high-quality confirmatory trials using standardised, comparable prevention regimens in different settings/regions.

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