Olive Oil's Cream Effectiveness in Prevention of Pressure Ulcers in Immobilized Patients in Primary Care.A Cluster Randomized Clinical Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Appearance grade II pressure ulcers
研究概览
简要总结
Pressure ulcers (UPP) represent an important sanitary problem affecting mostly elderly immobilized persons, increasing the burden of care to professionals in the health system, as well as pharmaceutical spending. There are studies of the effectiveness of various products in the prevention of the UPP, most made in hospitals and using fundamentally composed based on oily hyperbecome oxygenated acids (AGHO).
There do not exist studies realized specifically with cream of olive oil.
AIMS:
Principal: To verify the efficiency of a new intervention of UPP's prevention in immobilized patients consisting in the application of cream of olive oil. Secondary: To evaluate the cost - efficiency of this new intervention opposite to AGHO's application.
To value the degree of satisfaction of the patient and his keeper with regard to the use of cream of olive oil.
METHODOLOGY DESIGN: clinical Test randomized with two parallel branches. AREA: Population consultant of the health centers in the province of Malaga. SUBJECTS OF STUDY: Patients immobilized at the risk of developing UPP. INTERVENTION: Administration of cream of olive oil to the group of intervention and AGHO's administration to the group control. Follow-up for one year. VARIABLES. Principal variable: UPP's appearance. Secondary: Demographic and clinical data, presence of technical supports, information of the caragiver and questionnaire of satisfaction. STATISTICAL ANALYSIS: Test. Exact of Fischer. Odds's calculation ratio. Shapiro-Wilk's test. Parametric test t- student or test U of Mann-Whitney. Reason of the increase cost efficiency (ICER). Logistic regression model multivariant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hyper-oxigenated fatty acid
Hyper-oxigenated fatty acid,Equisetum arvense, Hypericum perforatum
干预措施: Hyper-oxigenated fatty acid (Drug)
Olive oil's Cream
Cream with 60% extra virgin olive oil.
干预措施: Olive oil's cream (Other)
结局指标
主要结局
Appearance grade II pressure ulcers
时间窗: 48 months
The primary outcome or result is the appearance of grade II pressure ulcers in patients under study during the 9 months follow up. This will be confirmed by observation of the areas where we did the intervention (sacrum, hips and heels).
次要结局
未报告次要终点
研究者
Francisco Javier Navarro Moya
Effectiveness and Research Unit Coordinator. Distrito Sanitario Málaga.
Andaluz Health Service
