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, Woodward Sue
Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK.
Skin Integrity Research Group (SKINT), University Centre for Nursing and Midwifery, Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.
Cochrane Database Syst Rev. 2025 Jul 11;7(7):CD011627. doi: 10.1002/14651858.CD011627.pub3.
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).
To assess the effects of skin care cleansers, leave-on products, and procedures for preventing incontinence-associated dermatitis in adults.
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.
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.
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.
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.
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.
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.
失禁相关性皮炎(IAD)是成年尿失禁、粪失禁或两者皆有的患者中常见的皮肤问题。预防措施包括皮肤护理干预,如皮肤清洁和使用皮肤保护剂/屏障(涂抹式产品)。
评估皮肤护理清洁剂、涂抹式产品以及预防成年失禁相关性皮炎的程序的效果。
2024年4月29日,我们检索了Cochrane尿失禁专业注册库(包括CENTRAL、MEDLINE、MEDLINE在研、MEDLINE Epub Ahead of Print、ClinicalTrials.gov和WHO ICTRP的检索结果),并手工检索了期刊和会议论文集。我们检索了纳入研究的参考文献列表以识别其他研究。
我们选择在任何医疗环境中开展的随机对照试验(RCT)和半随机对照试验,参与者年龄超过18岁,基线时无IAD。我们纳入了比较皮肤清洁干预措施和涂抹式产品或干预措施/涂抹式产品组合效果的试验。
三位综述作者独立筛选标题、摘要和全文文章。四位综述作者独立提取数据并评估偏倚风险。非英文发表研究的数据由Cochrane Engage的志愿者和综述作者网络进行翻译和提取。主要结局为:发生IAD的参与者数量以及与干预相关的不良反应(疼痛、皮疹、瘙痒和其他严重不良反应)。次要结局为:对皮肤护理产品或程序满意的参与者数量、整个干预过程中对方案协议的依从性以及生活质量(特定疾病或通用)。我们使用GRADE评估证据的确定性。
我们纳入了15项试验,共1020名参与者进行定性综合分析(41名来自养老院;65名来自养老院和医院,914名来自医院环境)。参与者存在尿失禁、粪失禁或两者皆有。13项试验样本量较小,两项试验分别有180名和174名参与者。六项试验在短期(≤7天)评估结局,四项在中期(8天至1个月)评估,一项在长期(>1个月至3个月)评估。在其余研究中,评估时间不明确。纳入研究的总体偏倚风险较高。大量异质性(在研究人群、皮肤护理产品、皮肤护理程序、结局和测量工具方面)妨碍了荟萃分析。三项试验比较了皮肤清洁干预措施,五项试验比较了涂抹式产品或涂抹式产品组合。七项试验比较了皮肤清洁剂和涂抹式产品的组合。失禁相关性皮炎的参与者数量三项试验比较了一种皮肤清洁剂与肥皂和水。一项研究提供的证据表明,使用泡沫清洁剂预防IAD可能比肥皂和水更有效(RR=0.35,95%CI 0.14至0.85;65名参与者;极低确定性证据),而另一项研究发现,含3%二甲基硅氧烷的一次性洗脸巾与肥皂和水在有效性上几乎没有差异(RR=0.14,95%CI 0.01至2.28;12名参与者;极低确定性证据)。第三项试验报告,与肥皂和水相比,免冲洗皮肤清洁剂的红斑评分更低,但我们无法分析这些数据。在评估皮肤清洁剂和涂抹式产品组合与单独皮肤清洁的试验中,一项试验表明联合治疗在预防IAD方面可能更有效(RR=0.03,95%CI 0.00至0.53;180名参与者;证据确定性极低),另一项试验表明干预措施之间几乎没有差异(RR=0.71,95%CI 0.14至3.68;31名参与者;极低确定性证据)。两项研究表明,涂抹式产品组合与单一产品之间几乎没有差异(RR=0.85,95%CI 0.36至2.02;74名参与者;极低确定性证据);(RR=0.25,95%CI =0.03至1.86;20名参与者;极低确定性证据)。总体而言,由于所有比较的证据确定性都非常低,我们无法就所测试干预措施预防IAD的有效性得出有意义的结论。
疼痛一项试验发现,并与未使用涂抹式产品进行清洁的人相比,使用皮肤清洁和涂抹式产品组合的人经历疼痛的人数更少(RR=0.33,95%CI 0.09至1.19;180名参与者;低确定性证据),另一项试验发现,与使用肥皂和水后再涂抹乳液的人相比,使用免冲洗皮肤清洁剂加皮肤霜的人出现疼痛的人数更少(RR=0.58,95%CI 0.19至1.74;31名参与者;低确定性证据)。然而,我们对这两项比较的分析表明,在相关疼痛方面,所测试的干预措施之间可能几乎没有差异。
瘙痒一项试验发现,与不使用涂抹式产品的传统皮肤护理方案相比,皮肤清洁和涂抹式产品与瘙痒的关联可能更少(RR=0.04,95%CI 0.01至0.29;180名参与者;低确定性证据)。
我们发现关于预防成年IAD干预措施有效性的证据有限,确定性低或极低。因此,尚不清楚单独使用或联合使用的任何皮肤清洁剂或涂抹式产品是否比其他产品效果更好。有一些非常不确定的证据表明,使用皮肤清洁剂预防IAD可能比肥皂和水更好,并且使用皮肤清洁剂与涂抹式产品的组合预防IAD可能比单独使用皮肤清洁剂更好。需要在不同环境/地区使用标准化、可比的预防方案进行高质量的验证性试验。