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| Name | Class |
|---|---|
| Danone Nutricia | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Study Group | 30 adult patients aged 30-75 years to receive a specialized tube feeding product Nutrison Advanced Cubison (20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period |
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| The Control Group | 30 patients aged 30-75 years to receive a standard (available in the clinic) tube feeding product (energetically similar to the product in group 1) with a standard content of arginine, vitamins and minerals from calculating the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g protein / kg body weight / day according to the recommendations for nutritional support for patients with pressure ulcers during the entire observation period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrison Advanced Cubison | Dietary Supplement | (20% protein energy 100 kcal, 5.5 g protein, 0.85 g arginine, 38 mg of vitamin C and 2 mg of zinc) in a volume not exceeding 1.5 liters / day and, if necessary, to replenish nutritional needs based on the total daily intake of 30-35 kcal / kg / day and 1.2-1.5 g of protein / kg body weight / day according to the recommendations for nutritional support |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the area of pressure ulcers in both groups during the study | up to 4 weeks | |
| 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 | up to 4 weeks | |
| Changes in the Pressure Ulcer Scale for Healing values in both groups during the study | 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 | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of treatment for pressure ulcers in study patients | up to 4 weeks | |
| Frequency and duration of infectious complications of pressure ulcers in study patients | up to 4 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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60 patients hospitalized with strokes or traumatic brain injury, who are on tube feeding and with the presence of pressure ulcers of 2-3 stages identified at baseline or during hospital stay
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Getman, Dr | Enrollme.ru, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GAUZ Bryansk city hospital №1 | Bryansk | Russia | ||||
| GBUZ GKB named after VV Vinogradov DZM |
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| 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 |
| Concentration of the C-reactive protein at the beginning and at the end of observations | up to 4 weeks |
| Moscow |
| Russia |
| Hospital named after V.D. Seredavin | Samara | Russia |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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