Prospective Multicenter Randomized Controlled Low-interventional Post-registration Study to Assess the Clinical Efficacy of the Specialized Enteral Tube Nutrition Composition Nutrison Advanced Cubison as a Part of Complex Pressure Ulcers (PU) Therapy Versus Standard Enteral Tube Nutrition Products
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- The proportion of patients in both groups with a decrease in the area of the pressure ulcer by 20% or more by the date of completion of observations
研究概览
简要总结
A large number of studies are devoted to studying the effect of patient nutrition on the occurrence and treatment of pressure ulcers. Several studies, including the US National Long-term Treatment of Pressure Ulcers Study, have shown that weight loss and malnutrition were associated with a higher risk of pressure ulcers.
One of the successful products specially created for the treatment of pressure ulcers and taking into account the results of research is the high-protein, energy-rich, ready-to-use enteral tube feeding food product Nutrison Advanced Cubison. It is a complete enteral nutritional supplement with an innovative nutrient composition for patients with chronic wounds, including pressure ulcers, or at increased risk of developing them.
Taking into account the available data, it seems expedient to continue studying the unique combination of nutrients that make up the study food product Nutrison Advanced Cubison in order to develop the most effective nutritional protocols for patients at risk for the treatment and prevention of pressure ulcers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with stroke / TBI and who are on tube feeding
- •Presence of pressure ulcers of 2-3 stages
- •Informed voluntary consent to medical intervention is formalized in accordance with the requirements of the Federal Law of 21.11.2011 N 323-FZ "On the basics of protecting the health of citizens in the Russian Federation."
排除标准
- •Hemodynamically unstable patients
- •Severe renal impairment (GFR <30 ml / min)
- •Moderate or severe liver failure (Child-Pugh Class B or C)
- •Oncological diseases (lasting more than 5 years)
- •Hypersensitivity to any component of the test food mixture
- •Inclusion in clinical interventional research
- •Uncertainty of the investigator about the willingness or ability of the subject to comply with the protocol requirements
- •Any other medical or non-medical reasons that, in the opinion of the physician, may prevent the patient from participating in the study
结局指标
主要结局
The proportion of patients in both groups with a decrease in the area of the pressure ulcer by 20% or more by the date of completion of observations
时间窗: up to 4 weeks
Changes in the area of pressure ulcers in both groups during the study
时间窗: up to 4 weeks
Changes in the Pressure Ulcer Scale for Healing values in both groups during the study
时间窗: up to 4 weeks
Pressure Ulcer Scale for Healing (PUSH) is a common tool to monitor pressure healing over time. The PUSH Tool monitors three parameters: surface area of the wound, wound exudate and type of wound tissue. Minimum value is 0, maximum value is 17. The bigger scale is the worse
次要结局
- Duration of treatment for pressure ulcers in study patients(up to 4 weeks)
- Concentration of the C-reactive protein at the beginning and at the end of observations(up to 4 weeks)
- Frequency and duration of infectious complications of pressure ulcers in study patients(up to 4 weeks)
- Concentration of the blood albumin at the beginning and at the end of observations(up to 4 weeks)
- Concentration of the blood lymphocytes at the beginning and at the end of observations(up to 4 weeks)