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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pressure Ulcer ( Stage 2-3)
- Sponsor
- Enrollme.ru, LLC
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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."
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Time Frame: up to 4 weeks
Changes in the area of pressure ulcers in both groups during the study
Time Frame: up to 4 weeks
Changes in the Pressure Ulcer Scale for Healing values in both groups during the study
Time Frame: 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
Secondary Outcomes
- 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)