Sofoklis Koudounas, PhD, Skin Health Research Group, School of Health Sciences, University of Southampton, Southampton, Hampshire, United Kingdom. Shabira Abbas, PhD, Essity AB, Gothenburg, Sweden. David Voegeli, PhD, RN, Skin Health Research Group, School of Health Sciences, University of Southampton, Southampton, Hampshire, United Kingdom; and Faculty of Health & Wellbeing, University of Winchester, Winchester, Hampshire, United Kingdom.
J Wound Ostomy Continence Nurs. 2020 Sep/Oct;47(5):497-506. doi: 10.1097/WON.0000000000000684.
The main aims of this study were to describe the effects of incontinence pad composition on skin wetness, the skin/pad microclimate, and skin barrier function. We also evaluated the potential utility of our methods for future clinical investigation of absorbent pad design.
Single-blind, quasi-experimental, open cohort design.
Twenty healthy older volunteers (mean age = 72.8 years, SD = 5.8 years; 8 male and 12 female) tested 2 absorbent pad types, with acquisition layers of different compositions (A and B) applied to different sites on the volar aspect of the forearms. One type A pad served as control (A dry) versus 3 pad samples wetted with 3 volumes of saline (A 15 mL, A 35 mL, and B 15 mL). The study was conducted within the clinical laboratory of a university nursing research group in the United Kingdom.
Skin barrier function was assessed by measuring transepidermal water loss (TEWL), stratum corneum (SC) hydration by corneometry, and skin surface pH using a standard skin pH electrode. Skin water loading (excess water penetration into the skin) was quantified by measuring TEWL and creating a desorption curve of the water vapor flux density. Calculating the area under the curve of the desorption curve to give skin surface water loss reflected excess water penetration into the skin. In a subgroup of the sample, the temperature and relative humidity (microclimate) at the interface between the skin and test pads were measured using a wafer-thin sensor placed between the skin and pad sample. Proinflammatory cytokine release from the SC was assessed using a noninvasive lipophilic film. The main outcome measures in this study were the differences in biophysical measurements of skin barrier function (TEWL, corneometer, and pH) before and after the application of the different pads.
Mean ± SD baseline TEWL across all test sites was 10.4 ± 4.4 g/h/m. This increased to 10.6 ± 3.8 g/h/m at the control site, 15.3 ± 6.3 g/h/m for the A 15-mL pad, 15.3 ± 3.9 g/h/m for the A 35-mL pad, and 15.6 ± 3.2 g/h/m for the B 15-mL pad. The mean baseline skin surface pH was 5.9 ± 0.04; cutaneous pH increased to a mean of 6.1 ± 0.06 following all pad applications (P = .16). Mean SC hydration remained unchanged at the control site (A dry). In contrast, SC hydration increased following the application of all wetted pads. Target cytokines were detected in all samples we analyzed. The IL-1RA/IL-1α ratio increased following pad application, except for the wettest pad.
Study findings suggest that absorbent pad design and composition, particularly the acquisition layer, affect performance and may influence skin health. Based on our experience with this study, we believe the methods we used provide a simple and objective means to evaluate product performance that could be used to guide the future development of products and applied to clinical settings.
本研究的主要目的是描述失禁垫组成对皮肤湿润度、皮肤/垫微气候和皮肤屏障功能的影响。我们还评估了我们的方法在未来吸收垫设计的临床研究中的潜在应用。
单盲、准实验、开放队列设计。
20 名健康的老年志愿者(平均年龄=72.8 岁,标准差=5.8 岁;8 名男性和 12 名女性)测试了 2 种吸收垫类型,其吸收层具有不同的组成(A 和 B)应用于前臂掌侧的不同部位。一种 A 型垫作为对照(A 干),而 3 种垫样本分别用 3 体积的生理盐水润湿(A 15mL、A 35mL 和 B 15mL)。该研究在英国大学护理研究小组的临床实验室进行。
通过测量经皮水分损失(TEWL)、角质层(SC)水合作用(通过皮肤电导率仪测量)和使用标准皮肤 pH 电极测量皮肤表面 pH 值来评估皮肤屏障功能。通过测量 TEWL 和创建水蒸气通量密度的解吸曲线来量化皮肤水分加载(过量水分渗透到皮肤中)。计算解吸曲线的曲线下面积,以反映皮肤表面水分损失反映过量水分渗透到皮肤中。在样本的一个亚组中,使用放置在皮肤和测试垫之间的薄片状传感器测量皮肤和测试垫之间界面的温度和相对湿度(微气候)。使用非侵入性亲脂性薄膜评估 SC 中促炎细胞因子的释放。本研究的主要观察指标是在应用不同垫后皮肤屏障功能(TEWL、皮肤电导率仪和 pH 值)的生物物理测量值的差异。
所有测试部位的平均±SD 基线 TEWL 为 10.4±4.4g/h/m。在对照部位增加到 10.6±3.8g/h/m,A 15-mL 垫增加到 15.3±6.3g/h/m,A 35-mL 垫增加到 15.3±3.9g/h/m,B 15-mL 垫增加到 15.6±3.2g/h/m。平均基线皮肤表面 pH 值为 5.9±0.04;所有垫应用后皮肤 pH 值增加到 6.1±0.06(P=0.16)。在对照部位(A 干),SC 水合作用保持不变。相比之下,所有润湿的垫应用后 SC 水合作用增加。我们分析的所有样本中均检测到目标细胞因子。除了最湿的垫外,IL-1RA/IL-1α 比值在垫应用后增加。
研究结果表明,吸收垫的设计和组成,特别是吸收层,会影响性能,并可能影响皮肤健康。根据我们在这项研究中的经验,我们相信我们使用的方法提供了一种简单和客观的方法来评估产品性能,可用于指导未来产品的开发,并应用于临床环境。