为肛周体型偏外者设计的凹陷轮廓布袋系统的体型适配性:对渗漏、佩戴时间和生活质量的影响:随机对照交叉试验。

IF 1.7 3区 医学 Q2 NURSING
Thomas Rolfsen, Martin Vestergaard, Mads Fuglesang Hansen, Esben Bo Boisen, Marianne Raff Dambæk
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引用次数: 0

摘要

目的:该研究的目的是调查带有凹形皮肤屏障的两件式造口袋系统与肛周体型外露者的匹配性,以及其对渗漏、佩戴时间和与使用造口产品相关的生活质量(QoL)的影响:设计:随机、对照、开放标签、交叉试验:样本包括 53 名具有外向肛周体型和造口袋污水渗漏问题的受试者。受试者被随机分配到凹形两件式造口袋系统或比较者(带平整皮肤屏障的两件式造口袋系统)中,为期 3 周。然后,受试者再换成相反的皮肤屏障,再使用 3 周。研究在丹麦、挪威、德国和荷兰进行;数据在多个流动诊所或家访中收集:主要终点是皮肤屏障贴合身体轮廓的能力;次要结果是造口袋系统的污水渗漏、佩戴时间以及通过有效的造口-Q 问卷调查与使用造口产品相关的 QoL。使用比例赔率模型和混合模型评估了凹面造口袋系统和对比造口袋系统之间的主要比较结果,并将测试时间考虑在内:分析对象包括至少接触过一种产品且至少有一个终点信息的随机受试者(完整分析集,n = 52)。凹面胃袋系统比对比产品更贴合人体轮廓(PC结论:研究结果表明,凹面胃袋系统比对比产品更贴合人体轮廓:研究结果表明,与使用平面皮肤屏障的布袋系统相比,凹面皮肤屏障的布袋系统能更好地贴合外周体型的人的身体,并能减少漏袋事件,提高 QoL。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Body Fit With a Pouching System With Concave Contour for People With an Outward Peristomal Body Profile: Effects on Leakage, Wear Time, and Quality of Life: A Randomized Controlled Cross-Over Trial.

Purpose: The purpose of the study was to investigate the fit of a two-piece pouching system with a concave-shaped skin barrier on people with an outward peristomal body profile and its effect on leakage, wear time, and quality of life (QoL) related to using an ostomy product.

Design: Randomized, controlled, open-label, cross-over trial.

Subjects and settings: The sample comprised 53 subjects with outward peristomal body profiles and problems with leakage of ostomy effluent from their pouching system. Participants were randomized to the concave two-piece pouching system or a comparator (two-piece pouching system with a flat skin barrier) for 3 weeks. Subjects were then crossed over to the opposite skin barrier for an additional 3 weeks. The study was conducted in Denmark, Norway, Germany, and the Netherlands; data were collected in multiple ambulatory clinics or during home visits.

Methods: The primary end point was the ability of the skin barrier to fit body contours; secondary outcomes were leakage of effluent from the pouching system, wear time, and QoL related to using an ostomy product via the validated Ostomy-Q questionnaire. Primary comparisons between concave and comparator pouching systems were evaluated using proportional odds models and mixed models taking test period into account.

Results: Analysis included randomized subjects who had been exposed to at least one product and with information on at least one end point (full-analysis-set, n = 52). The concave pouching system provided a better fit to body contours than the comparator (P< .001) and reduced the degree of leakage underneath the skin barrier (LS mean difference = -1.84, 95% CI -3.31 to -0.37; P = .016). Participants experienced fewer episodes of leakage outside the skin barrier when using concave versus comparator pouching system (13.0% vs. 26.7%, respectively). Participants reported significant improvements in QoL (LS mean difference = 14.3; 95% CI 9.4 to 19.2; P < .001). No significant difference in wear time between skin barrier shapes was reported.

Conclusions: Study findings indicate that a pouching system with a concave skin barrier achieved a better body fit on people with an outward peristomal body profile and resulted in fewer leakage incidents and higher QoL compared to using a pouching system with a flat skin barrier.

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来源期刊
CiteScore
3.10
自引率
34.60%
发文量
186
审稿时长
6-12 weeks
期刊介绍: ​​The Journal of Wound, Ostomy and Continence Nursing (JWOCN), the official journal of the Wound, Ostomy and Continence Nurses Society™ (WOCN®), is the premier publication for wound, ostomy and continence practice and research. The Journal’s mission is to publish current best evidence and original research to guide the delivery of expert health care. The WOCN Society is a professional nursing society which supports its members by promoting educational, clinical and research opportunities to advance the practice and guide the delivery of expert health care to individuals with wounds, ostomies and continence care needs.
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