Graham T, Beeckman D, Kottner J, Fader M, Fiorentino F, Fitzpatrick JM, Gray M, Harris RG, Sooriah S, Wallace SA, Worsley PR, Woodward S, et al.
The Cochrane database of systematic reviews. Date of publication 2025 Jul 11;volume 7(7):CD011627.
1. Cochrane Database Syst Rev. 2025 Jul 11;7(7):CD011627. doi:
10.1002/14651858.CD011627.pub3.
Skin cleansers and leave-on product interventions for preventing
incontinence-associated dermatitis in adults.
Graham T(1), Beeckman D(2)(3)(4)(5), Kottner J(6), Fader M(7), Fiorentino
F(1)(8), Fitzpatrick JM(1), Gray M(9), Harris RG(1), Sooriah S(1)(10), Wallace
SA(11), Worsley PR(12), Woodward S(1).
Author information:
(1)Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care,
King's College London, London, UK.
(2)Skin Integrity Research Group (SKINT), University Centre for Nursing and
Midwifery, Department of Public Health and Primary Care, Ghent University,
Ghent, Belgium.
(3)Swedish Centre for Skin and Wound Research (SCENTR), Nursing Science Unit,
School of Health Sciences, Faculty of Medicine and Health, Örebro University,
Örebro, Sweden.
(4)Department of Surgery, Monash Health, School of Clinical Sciences, Faculty of
Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
(5)Department of Clinical Research, Research Unit of Plastic Surgery, University
of Southern Denmark, Odense, Denmark.
(6)Institute for Clinical Nursing Science, Charité-Universitätsmedizin, Berlin,
Germany.
(7)School of Health Sciences, University of Southampton, Southampton, UK.
(8)Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
(9)Department of Urology, University of Virginia, Charlottesville, Virginia,
USA.
(10)Healthwatch Camden, London, UK.
(11)Evidence Synthesis Group, Population Health Sciences Institute, Faculty of
Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
(12)Skin Sensing Research Group, School of Health Sciences, University of
Southampton, Southampton, UK.
Update of
Cochrane Database Syst Rev. 2016 Nov 10;11:CD011627. doi:
10.1002/14651858.CD011627.pub2.
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.
Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons,
Ltd.
DOI: 10.1002/14651858.CD011627.pub3
PMCID: PMC12247456
PMID: 40643063 [Indexed for MEDLINE]
Conflict of interest statement: TG: none
DB: MOLNLYCKE HEALTH CARE US, LLC
(Independent Contractor ‐ Consultant); Urgo Medical North America, LLC
(Independent Contractor ‐ Consultant);
3M Company (Independent Contractor ‐
Consultant
JK: Hartman AG (Independent Contractor ‐ Consultant); 3M Company
(Grant / Contract); MOLNLYCKE HEALTH CARE US, LLC (Independent Contractor ‐
Consultant), Arjo (Grant / Contract). JK is involved in an ongoing study listed
in this review (El Genedy‐Kalyoncu 2022).
MF: none
FF: none
JMF: none
MG:
Coloplast Corp (Independent Contractor ‐ Consultant)
RHG: none
SS: none
SAW was
a Cochrane editor for the incontinence group until it closed in 2023. She was
not involved in the editorial process for this review.
PRW: none
SW: none
