Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Rate of Healing
研究概览
简要总结
Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient or legal guardian or caregiver consent
- •stage II, III or IV pressure ulcers
- •malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake [<60% of total daily estimated requirements])
- •patients who can drink supplements
- •home-care or long-term care
排除标准
- •decompensated diabetes (HbA1C >7%)
- •renal failure
- •hepatic failure (Child B and C)
- •current neoplastic disease
- •any organ-failure
- •immunosuppressive therapy
- •connective tissue disease
- •use of steroids
- •respiratory insufficiency (COPD)
- •anemia (haemoglobin <10g/dL)
- •previous neoplastic disease (<1 year since last treatment CT or RT)
- •infected wounds
- •cellulitis, sepsis or osteomyelitis
- •poor tolerance to sip feeding
结局指标
主要结局
Rate of Healing
时间窗: 8 weeks of nutritional support (baseline and week 8)
healing is defined as reduction in ulcer area (the percentage of change)
次要结局
- Incidence of Infections(8 weeks of nutritional support (baseline and week 8))
- the Percentage of Change in Area(4 weeks of nutritional support (baseline and week 4))
- Cost-effectiveness(8 weeks of nutritional support (baseline and week 8))
- Dressings(8 weeks of nutritional support (baseline and week 8))
- Rate of Healing(8 weeks of nutritional support (baseline and week 8))
研究者
FEDERICO D'ANDREA
Director of Clinical Nutrition Unit
Azienda Ospedaliero Universitaria Maggiore della Carita