Abstract：
UNASSIGNED: There is currently a wide range of cleansing and irrigation solutions available for wounds, many of which contain antimicrobial agents. The aim of this study was to assess the safety of HydroClean Solution (HARTMANN, Germany), a polyhexamethylene biguanide (PHMB)-containing irrigation solution, in a standard cytotoxicity assay, and to assess its effect in a three-dimensional (3D) full-thickness model of human skin.
UNASSIGNED: A number of commercially available wound cleansing and irrigation solutions, including the PHMB-containing irrigation solution, were tested in a cytotoxicity assay using L929 mouse fibroblasts (ISO 10993-5:2009). The PHMB-containing irrigation solution was then assessed in an in vitro human keratinocyte-fibroblast 3D full-thickness wounded skin model to determine its effect on wound healing over six days. The effect of the PHMB-containing irrigation solution on tissue viability was measured using a lactate dehydrogenase (LDH) assay, and proinflammatory effects were measured using an interleukin-6 (IL-6) production assay.
UNASSIGNED: The PHMB-containing irrigation solution was shown to be equivalent to other commercially available cleansing and irrigation solutions when tested in the L929 fibroblast cytotoxicity assay. When assessed in the in vitro 3D human full-thickness wound healing model, the PHMB-containing irrigation solution treatment resulted in no difference in levels of LDH or IL-6 when compared with levels produced in control Dulbecco\'s phosphate-buffered saline cultures. There was, however, a pronounced tissue thickening of the skin model in the periwound region.
UNASSIGNED: The experimental data presented in this study support the conclusion that the PHMB-containing irrigation solution has a safety profile similar to other commercially available cleansing and irrigation solutions. Evidence also suggests that the PHMB-containing irrigation solution does not affect tissue viability or proinflammatory cytokine production, as evidenced by LDH levels or the production of IL-6 in a 3D human full-thickness wound healing model. The PHMB-containing irrigation solution stimulated new tissue growth in the periwound region of the skin model.
UNASSIGNED: A number of commercially available wound cleansing and irrigation solutions, including the PHMB-containing irrigation solution, were tested in a cytotoxicity assay using L929 mouse fibroblasts (ISO 10993-5:2009). The PHMB-containing irrigation solution was then assessed in an in vitro human keratinocyte-fibroblast 3D full-thickness wounded skin model to determine its effect on wound healing over six days. The effect of the PHMB-containing irrigation solution on tissue viability was measured using a lactate dehydrogenase (LDH) assay, and proinflammatory effects were measured using an interleukin-6 (IL-6) production assay.
UNASSIGNED: The PHMB-containing irrigation solution was shown to be equivalent to other commercially available cleansing and irrigation solutions when tested in the L929 fibroblast cytotoxicity assay. When assessed in the in vitro 3D human full-thickness wound healing model, the PHMB-containing irrigation solution treatment resulted in no difference in levels of LDH or IL-6 when compared with levels produced in control Dulbecco\'s phosphate-buffered saline cultures. There was, however, a pronounced tissue thickening of the skin model in the periwound region.
UNASSIGNED: The experimental data presented in this study support the conclusion that the PHMB-containing irrigation solution has a safety profile similar to other commercially available cleansing and irrigation solutions. Evidence also suggests that the PHMB-containing irrigation solution does not affect tissue viability or proinflammatory cytokine production, as evidenced by LDH levels or the production of IL-6 in a 3D human full-thickness wound healing model. The PHMB-containing irrigation solution stimulated new tissue growth in the periwound region of the skin model.
摘要：
■目前有广泛的清洁和冲洗解决方案可用于伤口，其中许多含有抗菌剂。这项研究的目的是评估HydroClean解决方案的安全性(HARTMANN，德国),含有聚六亚甲基双胍(PHMB)的灌溉溶液，在标准的细胞毒性试验中，并在人体皮肤的三维（3D）全厚度模型中评估其效果。
■许多市售的伤口清洁和冲洗溶液，包括含PHMB的灌溉溶液，在使用L929小鼠成纤维细胞(ISO10993-5:2009)的细胞毒性测定中测试。然后在体外人角质形成细胞-成纤维细胞3D全厚度受伤皮肤模型中评估含PHMB的冲洗溶液,以确定其在六天内对伤口愈合的影响。使用乳酸脱氢酶（LDH）测定法测量含PHMB的冲洗溶液对组织活力的影响。使用白细胞介素-6（IL-6）产生测定法测量促炎作用。
■当在L929成纤维细胞细胞毒性测定中测试时,显示含有PHMB的冲洗溶液与其他市售清洁和冲洗溶液等同。当在体外3D人类全层伤口愈合模型中评估时，与对照Dulbecco的磷酸盐缓冲盐培养物中产生的LDH或IL-6水平相比，含PHMB的冲洗溶液处理没有导致差异。有,然而,伤口周围区域皮肤模型的明显组织增厚。
■本研究中提供的实验数据支持以下结论：含PHMB的灌溉溶液具有与其他市售清洁和灌溉溶液相似的安全概况。证据还表明，含PHMB的冲洗溶液不会影响组织活力或促炎细胞因子的产生。如在3D人全厚度伤口愈合模型中LDH水平或IL-6的产生所证明。含PHMB的冲洗溶液刺激皮肤模型的伤口周围区域中的新组织生长。
■许多市售的伤口清洁和冲洗溶液，包括含PHMB的灌溉溶液，在使用L929小鼠成纤维细胞(ISO10993-5:2009)的细胞毒性测定中测试。然后在体外人角质形成细胞-成纤维细胞3D全厚度受伤皮肤模型中评估含PHMB的冲洗溶液,以确定其在六天内对伤口愈合的影响。使用乳酸脱氢酶（LDH）测定法测量含PHMB的冲洗溶液对组织活力的影响。使用白细胞介素-6（IL-6）产生测定法测量促炎作用。
■当在L929成纤维细胞细胞毒性测定中测试时,显示含有PHMB的冲洗溶液与其他市售清洁和冲洗溶液等同。当在体外3D人类全层伤口愈合模型中评估时，与对照Dulbecco的磷酸盐缓冲盐培养物中产生的LDH或IL-6水平相比，含PHMB的冲洗溶液处理没有导致差异。有,然而,伤口周围区域皮肤模型的明显组织增厚。
■本研究中提供的实验数据支持以下结论：含PHMB的灌溉溶液具有与其他市售清洁和灌溉溶液相似的安全概况。证据还表明，含PHMB的冲洗溶液不会影响组织活力或促炎细胞因子的产生。如在3D人全厚度伤口愈合模型中LDH水平或IL-6的产生所证明。含PHMB的冲洗溶液刺激皮肤模型的伤口周围区域中的新组织生长。
