Clinical trial 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
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer ( Stage 2-3)
Keywords: Stroke
Traumatic Brain Injury
Lead sponsor: Enrollme.ru, LLC
Sponsor class: NETWORK
Collaborators: name: Danone Nutricia
First posted: 2022-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the area of pressure ulcers in both groups during the study
timeFrame: up to 4 weeks
measure: 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
timeFrame: up to 4 weeks
measure: Changes in the Pressure Ulcer Scale for Healing values in both groups during the study
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Duration of treatment for pressure ulcers in study patients
timeFrame: up to 4 weeks
measure: Frequency and duration of infectious complications of pressure ulcers in study patients
timeFrame: up to 4 weeks
measure: Concentration of the blood albumin at the beginning and at the end of observations
timeFrame: up to 4 weeks
measure: Concentration of the blood lymphocytes at the beginning and at the end of observations
timeFrame: up to 4 weeks
measure: Concentration of the C-reactive protein at the beginning and at the end of observations
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Bryansk
country: Russian Federation
facility: GAUZ Bryansk city hospital №1
city: Moscow
country: Russian Federation
facility: GBUZ GKB named after VV Vinogradov DZM
city: Samara
country: Russian Federation
facility: Hospital named after V.D. Seredavin
Study officials:
affiliation: Enrollme.ru, LLC
name: Mikhail Getman, Dr
role: STUDY_DIRECTOR
References: