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

NCT05461911 | Completed

• 1 other identifier: DECUBISON
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Pressure Ulcer ( Stage 2-3)

Keywords

Stroke; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

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

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

Interventions

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

The Study Group

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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."

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Enrollme.ru, LLC: lead
• Danone Nutricia: collaborator

Study Sites (3)

GAUZ Bryansk city hospital №1

Bryansk, Russia

Location

GBUZ GKB named after VV Vinogradov DZM

Moscow, Russia

Location

Hospital named after V.D. Seredavin

Samara, Russia

Location

MeSH Terms

Conditions

Pressure Ulcer; Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Mikhail Getman, Dr

  Enrollme.ru, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 18, 2022
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

RU (3)