Lupiáñez-Pérez Inmaculada, Morilla-Herrera Juan Carlos, Ginel-Mendoza Leovigildo, Martín-Santos Francisco Javier, Navarro-Moya Francisco Javier, Sepúlveda-Guerra Rafaela Pilar, Vázquez-Cerdeiros Rosa, Cuevas-Fernández-Gallego Magdalena, Benítez-Serrano Isabel María, Lupiáñez-Pérez Yolanda, Morales-Asencio José Miguel
District of Primary Health Care Malaga-Guadalhorce, Andalusian Health Service, Malaga, Spain.
Trials. 2013 Oct 23;14:348. doi: 10.1186/1745-6215-14-348.
Pressure ulcers are considered an important issue, mainly affecting immobilized older patients. These pressure ulcers increase the care burden for the professional health service staff as well as pharmaceutical expenditure. There are a number of studies on the effectiveness of different products used for the prevention of pressure ulcers; however, most of these studies were carried out at a hospital level, basically using hyperoxygenated fatty acids (HOFA). There are no studies focused specifically on the use of olive-oil-based products and therefore this research is intended to find the most cost-effective treatment and achieve an alternative treatment.
METHODS/DESIGN: The main objective is to assess the effectiveness of olive oil, comparing it with HOFA, to treat immobilized patients at home who are at risk of pressure ulcers. As a secondary objective, the cost-effectiveness balance of this new application with regard to the HOFA will be assessed. The study is designed as a noninferiority, triple-blinded, parallel, multi-center, randomized clinical trial. The scope of the study is the population attending primary health centers in Andalucía (Spain) in the regional areas of Malaga, Granada, Seville, and Cadiz. Immobilized patients at risk of pressure ulcers will be targeted. The target group will be treated by application of an olive-oil-based formula whereas the control group will be treated by application of HOFA to the control group. The follow-up period will be 16 weeks. The main variable will be the presence of pressure ulcers in the patient. Secondary variables include sociodemographic and clinical information, caregiver information, and whether technical support exists. Statistical analysis will include the Kolmogorov-Smirnov test, symmetry and kurtosis analysis, bivariate analysis using the Student's t and chi-squared tests as well as the Wilcoxon and the Man-Whitney U tests, ANOVA and multivariate logistic regression analysis.
The regular use of olive-oil-based formulas should be effective in preventing pressure ulcers in immobilized patients, thus leading to a more cost-effective product and an alternative treatment.
Clinicaltrials.gov identifier: NCT01595347.
压疮被视为一个重要问题，主要影响行动不便的老年患者。这些压疮增加了专业医疗卫生服务人员的护理负担以及药物支出。关于用于预防压疮的不同产品的有效性已有多项研究；然而，这些研究大多是在医院层面进行的，主要使用的是高氧脂肪酸（HOFA）。目前尚无专门针对基于橄榄油的产品使用情况的研究，因此本研究旨在找到最具成本效益的治疗方法并实现替代治疗。
方法/设计：主要目的是评估橄榄油与HOFA相比，对在家中存在压疮风险的行动不便患者的治疗效果。作为次要目的，将评估这种新应用相对于HOFA的成本效益平衡。该研究设计为非劣效性、三盲、平行、多中心、随机临床试验。研究范围是西班牙安达卢西亚地区马拉加、格拉纳达、塞维利亚和加的斯等区域的初级卫生保健中心的就诊人群。将以存在压疮风险的行动不便患者为目标对象。目标组将通过应用基于橄榄油的配方进行治疗，而对照组将通过应用HOFA进行治疗。随访期为16周。主要变量将是患者是否存在压疮。次要变量包括社会人口统计学和临床信息、护理人员信息以及是否存在技术支持。统计分析将包括柯尔莫哥洛夫 - 斯米尔诺夫检验、对称性和峰度分析、使用学生t检验和卡方检验以及威尔科克森检验和曼 - 惠特尼U检验的双变量分析、方差分析和多变量逻辑回归分析。
定期使用基于橄榄油的配方应该能够有效预防行动不便患者的压疮，从而产生一种更具成本效益的产品和一种替代治疗方法。
Clinicaltrials.gov标识符：NCT01595347。
