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

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer ( Stage 2-3)
• Intervention / Treatment: Dietary supplement: Nutrison Advanced Cubison

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Russian Federation
  • Bryansk, Russian Federation
    • GAUZ Bryansk city hospital №1
  • Moscow, Russian Federation
    • GBUZ GKB named after VV Vinogradov DZM
  • Samara, Russian Federation
    • Hospital named after V.D. Seredavin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Dietary supplement: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Enrollme.ru, LLC
• Collaborators: Danone Nutricia
• Investigators: Study Director: Mikhail Getman, Dr, Enrollme.ru, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: DECUBISON

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No