Sætre Ragne, Gotfredsen Johanne L, Nonboe Pernille, Hansen Helle Doré, Mathiesen Ronja, Karlsmark Tonny, Størling Zenia M, Rolfsen Thomas
Sykepleierklinikken A/S, Larvik, Norway.
Medical Affairs, Coloplast A/S, Humlebaek, Denmark.
Br J Dermatol. 2023 Mar 30;188(4):474-481. doi: 10.1093/bjd/ljac122.
Peristomal skin complications (PSCs) are the predominant complication for people living with a stoma, negatively affecting their health-related quality of life (HRQoL). PSCs may also have an impact on healthcare costs for society with more visits to healthcare professionals and increased consumption of products and treatment strategies, which amplifies the need for new strategies to reduce or prevent PSCs.
To evaluate the performance of an ostomy baseplate with a skin-protection technology. The target group comprised people living with a stoma with liquid faecal effluent, who struggled with PSCs.
A randomized, controlled, open-labelled, cross-over trial was conducted from September 2021 to February 2022 in five different countries. Each participant tested the investigational product against a comparator product (SenSura® Mio). The Ostomy Skin Tool 2.0 was used to evaluate the peristomal skin and HRQoL was measured using the Dermatology Life Quality Index (DLQI) questionnaire. Data were analysed in mixed repeated-measures models.
A total of 79 adult participants (mean age 54.5 years, female 45.6%) were included in the intention-to-treat (ITT) population. A significant reduction in PSCs (P = 0.015) and HRQoL (P = 0.035) was found for the investigational product when compared with the comparator product. Also, significantly more study participants preferred the investigational product when compared with the comparator product (P = 0.017).
The investigational product, an ostomy baseplate with a skin-protective technology, reduced PSCs and improved the HRQoL of people living with a stoma with liquid faecal effluent. Consequently, the investigational product was the preferred ostomy appliance of the participants. Thus, the product investigated in this study may be a new solution to be included in everyday clinical practice to overcome leakage-induced PSCs for people living with a stoma.
造口周围皮肤并发症（PSCs）是造口患者的主要并发症，对其健康相关生活质量（HRQoL）产生负面影响。PSCs还可能影响社会医疗成本，因为患者需要更多地就诊于医疗专业人员，并且产品和治疗策略的消耗增加，这凸显了需要新的策略来减少或预防PSCs。
评估一种具有皮肤保护技术的造口底盘的性能。目标人群包括有液体粪便流出物的造口患者，他们深受PSCs困扰。
2021年9月至2022年2月在五个不同国家进行了一项随机、对照、开放标签、交叉试验。每位参与者将研究产品与对照产品（SenSura® Mio）进行测试。使用造口皮肤工具2.0评估造口周围皮肤，并使用皮肤病生活质量指数（DLQI）问卷测量HRQoL。数据在混合重复测量模型中进行分析。
意向性分析（ITT）人群共纳入79名成年参与者（平均年龄54.5岁，女性占45.6%）。与对照产品相比，研究产品的PSCs（P = 0.015）和HRQoL（P = 0.035）显著降低。此外，与对照产品相比，明显更多的研究参与者更喜欢研究产品（P = 0.017）。
研究产品是一种具有皮肤保护技术的造口底盘，减少了PSCs，改善了有液体粪便流出物的造口患者的HRQoL。因此，研究产品是参与者首选的造口器具。因此，本研究中所研究的产品可能是日常临床实践中一种新的解决方案，用于克服造口患者因渗漏引起的PSCs。
