Skip to main content
OpenTrials
Completed

NCT Number: NCT05461911

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pressure Ulcer ( Stage 2-3) Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GAUZ Bryansk city hospital №1, Bryansk, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Changes in the area of pressure ulcers in both groups during the study

    Time frame: up to 4 weeks

  2. 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

  3. 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

  1. Duration of treatment for pressure ulcers in study patients

    Time frame: up to 4 weeks

  2. Frequency and duration of infectious complications of pressure ulcers in study patients

    Time frame: up to 4 weeks

  3. Concentration of the blood albumin at the beginning and at the end of observations

    Time frame: up to 4 weeks

  4. Concentration of the blood lymphocytes at the beginning and at the end of observations

    Time frame: up to 4 weeks

  5. Concentration of the C-reactive protein at the beginning and at the end of observations

    Time frame: up to 4 weeks

Sponsors and collaborators

Lead sponsor

Enrollme.ru, LLC

Network

Collaborators

  • Danone Nutricia

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.