Department of Nursing, University of Jaén, Jaén, Spain; Instituto de Investigación Biosanitaria (ibs.GRANADA), Granada, Spain; Centro de Investigación Mente, Cerebro y Comportamiento (CIMCYC), Granada, Spain.
Virgen de las Nieves University Hospital, Granada, Spain.
J Tissue Viability. 2023 May;32(2):188-193. doi: 10.1016/j.jtv.2023.02.004. Epub 2023 Feb 11.
To assess the efficacy and safety of the application, during stoma hygiene, of a pH-neutral gel containing organic EVOO (oEVOO) for the maintenance of peristomal skin integrity.
Patients with a colostomy or ileostomy were enrolled in a pilot randomized controlled trial and assigned treatment with a pH-neutral gel made from natural products including oEVOO or usual stoma hygiene gel. The primary outcome was three domains of abnormal peristomal skin: Discolouration, Erosion and Tissue overgrowth. Secondary outcomes that were evaluated included skin moisture; oiliness; skin elasticity; water-oil balance; patients' perceptions; difficulty inserting and removing the pouching system; pain, any other chemical, infectious, mechanical, or immunological complications of concern. The intervention lasted 8 weeks.
Twenty-one patients were recruited for the trial and randomly assigned to either the experimental group (n = 12) or the control group (n = 9). The groups did not differ significantly in terms of patient characteristics. No significant differences between groups were identified either at baseline (p = 0.203) or at the end of the intervention (p = 0.397). In the experimental group, domains of abnormal peristomal skin improved after the intervention. The difference observed before and after the intervention was statistically significant (p = 0.031).
The use of a gel containing oEVOO has shown similar levels of efficacy and safety to other gels commonly used for peristomal skin hygiene. It is also relevant to highlight that a significant improvement in skin condition was observed in the experimental group before and after the intervention.
评估在造口护理期间应用含有有机特级初榨橄榄油（oEVOO）的 pH 中性凝胶维持造口周围皮肤完整性的疗效和安全性。
将患有结肠造口或回肠造口的患者纳入一项试点随机对照试验，并分配接受由天然产品制成的 pH 中性凝胶治疗，这些天然产品包括 oEVOO 或常规造口护理凝胶。主要结局是造口周围皮肤的三个异常领域：变色、侵蚀和组织过度生长。评估的次要结局包括皮肤水分、油性、皮肤弹性、水油平衡、患者感知、插入和移除造口袋系统的难度、疼痛、任何其他化学、感染、机械或免疫相关并发症。干预持续 8 周。
该试验招募了 21 名患者，并随机分配到实验组（n=12）或对照组（n=9）。两组患者的特征无显著差异。在基线（p=0.203）或干预结束时（p=0.397），两组之间也未发现显著差异。在实验组，造口周围皮肤异常的各个领域在干预后均得到改善。干预前后观察到的差异具有统计学意义（p=0.031）。
含有 oEVOO 的凝胶的使用显示出与其他常用于造口周围皮肤卫生的凝胶相似的疗效和安全性。同样值得注意的是，实验组在干预前后观察到皮肤状况显著改善。
