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

Enrollme.ru

Status: Completed

Conditions: Pressure Ulcer ( Stage 2-3)

Treatments: Dietary Supplement: Nutrison Advanced Cubison

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT05461911

DECUBISON

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 30 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

The Study Group

Description:

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

Treatment:

Dietary Supplement: Nutrison Advanced Cubison

The Control Group

Description:

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