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• W3025622030 abstract "To determine the effectiveness of a hydrophobic dressing (Cutimed Sorbact® ) against a silver dressing (Aquacel® Ag Extra) in the level of colonization of chronic venous leg ulcers. The secondary endpoints are health-related quality of life, level of pain, and time to complete healing.Open randomized controlled trial, with blinded endpoint.Patients with chronic venous leg ulcers with signs of critical colonization will be randomized in a concealed sequence using computer software to receive one of the alternative dressings. A total of 204 participants recruited in Primary Health Care and nursing homes will be necessary to assure statistical power. Measures will include sociodemographic variables, wound-related variables (area, exudate, and time to healing), level of pain, adverse effects, and health-related quality of life. Smear samples will be collected from the ulcers and will be subject to DNA-typing technique through polymerase chain reaction to obtain the level of colony-forming units. Measures will be collected at baseline, 4, 8, and 12 weeks.Elevated levels of microorganisms prevent wound healing and favour its chronification. The main target when colonization is present is to reduce the bacterial load to levels that promote immune system mobilization. Hydrophobic dressings prevent the formation of biofilm in the wound by means of physical effect, so that the possibility of antimicrobial resistance is significantly reduced.Current evidence about the effectiveness of dressings to minimize venous leg ulcers colonization is very limited. Previous studies have important methodological flaws. This study will permit to obtain the effectiveness of hydrophobic dressings against silver dressings with a robust design based on conditions of routine clinical practice in Primary Health Care and nursing homes.目的: 本研究旨在测定疏水性敷料(Cutimed Sorbact®)与含银敷料(Aquacel®Ag Extra)在下肢慢性静脉性溃疡的细菌定植水平方面的有效性。次要终点包括:健康相关生活质量、疼痛程度和完全愈合时间。 设计: 开放式随机对照试验(盲终点)。 方法: 利用计算机软件,按照隐性顺序,安排有严重细菌定植迹象的下肢慢性静脉性溃疡患者随机接受其中一种替代敷料。为保证统计功效,需要在初级保健护理院和养老院共招募204名受试者。衡量指标将包括社会人口统计变量、伤口相关变量(伤口大小、渗出物和愈合时间)、疼痛程度、不良反应和与健康相关生活质量。从溃疡处采集涂片样本,通过聚合酶链反应,采用DNA分型技术,对涂片样本进行分析,以获得菌落形成单位的水平。在基准日期、4周、8周和12周收集测量值。 讨论: 微生物水平升高会阻碍伤口愈合,会促成疼痛迁延化。当出现定植时,主要目标是将菌载量降低至促进免疫系统动员的水平。疏水性敷料通过物理作用防止伤口内形成生物膜,从而明显降低耐药的可能性。 影响: 目前有关敷料最大限度地减少下肢静脉溃疡定植的有效性的证据非常有限。以往的研究在方法上存在重大缺陷。本研究将允许根据初级保健护理院和养老院的常规临床实践条件,通过可靠设计,获得疏水性敷料和含银敷料的有效性。." @default.
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• W3025622030 date "2020-06-08" @default.
• W3025622030 modified "2023-10-17" @default.
• W3025622030 title "Effectiveness of a hydrophobic dressing for microorganisms’ colonization of vascular ulcers: Protocol for a randomized controlled trial (CUCO‐UV Study)" @default.
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• W3025622030 doi "https://doi.org/10.1111/jan.14412" @default.
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