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

NCT06726486 | Completed Phase 4

• 1 other identifier: 84.21
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Multimorbidity; Comorbidity; Malnutrition; Pressure Ulcer Prevention

Keywords

Multimorbidity; Comorbidity; Malnutrition; Pressure Ulcer; Supplements; Immunonutrients

Outcome Measures

Primary Outcomes (8)

• Presence of pressure-related injuries

  Dichotomous variable: Yes/No.

  15 and 30 days

• Risk of developing pressure-related injuries

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

  15 and 30 days

• Categorization of pressure-related injuries

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

  15 and 30 days

• Pressure-related injuries healing

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

  15 and 30 days

• Degree of dependence

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

  0, 15, and 30 days.

• Weight loss

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

  0, 15 and 30 days.

• % of dietary intake

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

  15 and 30 days.

• ONS adherence

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

  15 and 30 days.

Study Arms (2)

Intervention Group (Atémpero)

EXPERIMENTAL

Participants received an arginine-enriched ONS called Atémpero®.

Dietary Supplement: Atémpero

Control Group

ACTIVE COMPARATOR

Participants received a complete high-protein, high-calorie diet with mixed fiber.

Dietary Supplement: Control (Standard treatment)

Interventions

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.

Intervention Group (Atémpero)

Control (Standard treatment) DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Vegenat Healthcare: collaborator
• Instituto de investigación e innovación biomédica de Cádiz: collaborator

Study Sites (1)

Punta Europa University of Cadiz

Algeciras, Cadiz, 11207, Spain

Location

Related Publications (22)

• Liu P, Shen WQ, Chen HL. Efficacy of arginine-enriched enteral formulas for the healing of pressure ulcers: a systematic review. J Wound Care. 2017 Jun 2;26(6):319-323. doi: 10.12968/jowc.2017.26.6.319.

  PMID: 28598762 BACKGROUND

• Barchitta M, Maugeri A, Favara G, Magnano San Lio R, Evola G, Agodi A, Basile G. Nutrition and Wound Healing: An Overview Focusing on the Beneficial Effects of Curcumin. Int J Mol Sci. 2019 Mar 5;20(5):1119. doi: 10.3390/ijms20051119.

  PMID: 30841550 BACKGROUND

• Cheshmeh S, Hojati N, Mohammadi A, Rahmani N, Moradi S, Pasdar Y, Elahi N. The use of oral and enteral tube-fed arginine supplementation in pressure injury care: A systematic review and meta-analysis. Nurs Open. 2022 Nov;9(6):2552-2561. doi: 10.1002/nop2.974. Epub 2021 Jun 25.

  PMID: 34170617 BACKGROUND

• Yatabe J, Saito F, Ishida I, Sato A, Hoshi M, Suzuki K, Kameda T, Ueno S, Yatabe MS, Watanabe T, Sanada H. Lower plasma arginine in enteral tube-fed patients with pressure ulcer and improved pressure ulcer healing after arginine supplementation by Arginaid Water. J Nutr Health Aging. 2011 Apr;15(4):282-6. doi: 10.1007/s12603-010-0306-4.

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• Volkert D, Beck AM, Cederholm T, Cruz-Jentoft A, Hooper L, Kiesswetter E, Maggio M, Raynaud-Simon A, Sieber C, Sobotka L, van Asselt D, Wirth R, Bischoff SC. ESPEN practical guideline: Clinical nutrition and hydration in geriatrics. Clin Nutr. 2022 Apr;41(4):958-989. doi: 10.1016/j.clnu.2022.01.024. Epub 2022 Mar 5.

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  PMID: 27410392 BACKGROUND

• Clark RK, Stampas A, Kerr KW, Nelson JL, Sulo S, Leon-Novelo L, Ngan E, Pandya D. Evaluating the impact of using a wound-specific oral nutritional supplement to support wound healing in a rehabilitation setting. Int Wound J. 2023 Jan;20(1):145-154. doi: 10.1111/iwj.13849. Epub 2022 Jun 9.

  PMID: 35684975 BACKGROUND

• Wood J, Brown B, Bartley A, Margarida Batista Custodio Cavaco A, Roberts AP, Santon K, Cook S. Reducing pressure ulcers across multiple care settings using a collaborative approach. BMJ Open Qual. 2019 Aug 20;8(3):e000409. doi: 10.1136/bmjoq-2018-000409. eCollection 2019.

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• Stracci G, Scarpellini E, Rinninella E, Mignini EV, Clementi N, Boni MV, Valeri MV, Sansoni D, Abenavoli L, Gasbarrini A, Rasetti C, Santori P. Effects of enteral nutrition on patients with pressure lesions: a single center, pilot study. Eur Rev Med Pharmacol Sci. 2020 Feb;24(3):1563-1570. doi: 10.26355/eurrev_202002_20214.

  PMID: 32096205 BACKGROUND

• Wung Buh A, Mahmoud H, Chen W, McInnes MDF, Fergusson DA. Effects of implementing Pressure Ulcer Prevention Practice Guidelines (PUPPG) in the prevention of pressure ulcers among hospitalised elderly patients: a systematic review protocol. BMJ Open. 2021 Mar 12;11(3):e043042. doi: 10.1136/bmjopen-2020-043042.

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• Jaul E, Barron J, Rosenzweig JP, Menczel J. An overview of co-morbidities and the development of pressure ulcers among older adults. BMC Geriatr. 2018 Dec 11;18(1):305. doi: 10.1186/s12877-018-0997-7.

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• Jaul E, Menczel J. A comparative, descriptive study of systemic factors and survival in elderly patients with sacral pressure ulcers. Ostomy Wound Manage. 2015 Mar;61(3):20-6.

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• Guest JF, Ayoub N, McIlwraith T, Uchegbu I, Gerrish A, Weidlich D, Vowden K, Vowden P. Health economic burden that different wound types impose on the UK's National Health Service. Int Wound J. 2017 Apr;14(2):322-330. doi: 10.1111/iwj.12603. Epub 2016 May 26.

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• Li Z, Lin F, Thalib L, Chaboyer W. Global prevalence and incidence of pressure injuries in hospitalised adult patients: A systematic review and meta-analysis. Int J Nurs Stud. 2020 May;105:103546. doi: 10.1016/j.ijnurstu.2020.103546. Epub 2020 Jan 31.

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• Saghaleini SH, Dehghan K, Shadvar K, Sanaie S, Mahmoodpoor A, Ostadi Z. Pressure Ulcer and Nutrition. Indian J Crit Care Med. 2018 Apr;22(4):283-289. doi: 10.4103/ijccm.IJCCM_277_17.

  PMID: 29743767 BACKGROUND

• Ledger L, Worsley P, Hope J, Schoonhoven L. Patient involvement in pressure ulcer prevention and adherence to prevention strategies: An integrative review. Int J Nurs Stud. 2020 Jan;101:103449. doi: 10.1016/j.ijnurstu.2019.103449. Epub 2019 Oct 14.

  PMID: 31706155 BACKGROUND

• Cichosz SL, Voelsang AB, Tarnow L, Hasenkam JM, Fleischer J. Prediction of In-Hospital Pressure Ulcer Development. Adv Wound Care (New Rochelle). 2019 Jan 1;8(1):1-6. doi: 10.1089/wound.2018.0803. Epub 2019 Jan 5.

  PMID: 30705784 BACKGROUND

• Cereda E, Neyens JCL, Caccialanza R, Rondanelli M, Schols JMGA. Efficacy of a Disease-Specific Nutritional Support for Pressure Ulcer Healing: A Systematic Review and Meta-Analysis. J Nutr Health Aging. 2017;21(6):655-661. doi: 10.1007/s12603-016-0822-y.

  PMID: 28537329 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Pressure Ulcer

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-blind parallel Randomized Controlled Clinical Trial.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Unending.
• Access Criteria: All data from this study will be available upon request to the author by correspondence, under justified reasons.

Locations

ES (1)