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

Phase 4

Completed

• Conditions: Multimorbidity; Comorbidity; Malnutrition; Pressure Ulcer Prevention

• Registration Number: NCT06726486
• Lead Sponsor: University of Cadiz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Presence of pressure-related injuries	15 and 30 days	Dichotomous variable: Yes/No.
Risk of developing pressure-related injuries	15 and 30 days	Measurement instrument: Braden scale (low risk, moderate risk, high risk).
Categorization of pressure-related injuries	15 and 30 days	Measurement instrument: PUSH scale (I, II, III, IV).
Pressure-related injuries healing	15 and 30 days	Measurement instrument: PUSH scale (closed, epithelial tissue, granulation tissue, sphacelium, necrotic tissue).
Degree of dependence	0, 15, and 30 days.	Measurement instruments (description): Barthel score (independent, mild, moderate, severe).
Weight loss	0, 15 and 30 days.	Measurement instruments (description): Weight scale (kg).
% of dietary intake	15 and 30 days.	0%, 25%, 50%, 75%, 100% intake.
ONS adherence	15 and 30 days.	0%, 25%, 50%, 75%, 100% intake.

Trial Locations

Locations (1)

Punta Europa University of Cadiz; 🇪🇸 Algeciras, Cadiz, Spain