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Completed

NCT Number: NCT06726486

Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores

The goal of this study is to evaluate the efficacy of a hypercaloric, hyperproteic enteral formula enriched with immunonutrients in preventing and treating pressure injuries in hospitalized malnourished patients.

Participants will take enteral formula (a complete hyperproteic and hypercaloric oral nutritional supplement with a fibre mixture enriched in omega 3, L-arginine and nucleotides, providing vitamin C and Zinc) or a hyperproteic and hypercaloric oral nutritional supplement with fibre mixture every day for 30 days.

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Key information

Conditions

Multimorbidity Comorbidity Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pressure Ulcer Pressure Ulcer Prevention Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Punta Europa University of Cadiz

Algeciras, Cadiz, 11207, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hospitalized chronic patients with complex needs in the Internal Medicine Department of a regional hospital.
  • Malnourished or at risk of malnutrition.
  • Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.

Exclusion criteria

  • Limitations in oral intake (due to pathologies, state of health, among others).
  • Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.

Treatment and study plan

Atémpero

Dietary Supplement

A complete hyperproteic and hypercaloric diet with a mixture of fibres enriched in omega 3, L-arginine and nucleotides (which provides vitamin C and Zinc) was administered.

Control (Standard treatment)

Dietary Supplement

A complete high-protein and high-calorie diet with mixed fibre was administered.

Primary outcomes

  1. Presence of pressure-related injuries

    Time frame: 15 and 30 days

    Dichotomous variable: Yes/No.

  2. Risk of developing pressure-related injuries

    Time frame: 15 and 30 days

    Measurement instrument: Braden scale (low risk, moderate risk, high risk).

  3. Categorization of pressure-related injuries

    Time frame: 15 and 30 days

    Measurement instrument: PUSH scale (I, II, III, IV).

  4. Pressure-related injuries healing

    Time frame: 15 and 30 days

    Measurement instrument: PUSH scale (closed, epithelial tissue, granulation tissue, sphacelium, necrotic tissue).

  5. Degree of dependence

    Time frame: 0, 15, and 30 days.

    Measurement instruments (description): Barthel score (independent, mild, moderate, severe).

  6. Weight loss

    Time frame: 0, 15 and 30 days.

    Measurement instruments (description): Weight scale (kg).

  7. % of dietary intake

    Time frame: 15 and 30 days.

    0%, 25%, 50%, 75%, 100% intake.

  8. ONS adherence

    Time frame: 15 and 30 days.

    0%, 25%, 50%, 75%, 100% intake.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Collaborators

  • Instituto de investigación e innovación biomédica de Cádiz
  • Vegenat Healthcare

Registry information

Official study title

Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

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.

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