Use of a Hypercaloric and Hyperprotein Supplement Enriched with Immunonutrients in Multi-pathological Malnourished Patients to Improve the Incidence and Prevalence of Pressure Sores
NCT ID: NCT06726486
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2022-01-01
2023-04-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention Group (Atémpero)
Participants received an arginine-enriched ONS called Atémpero®.
Atémpero
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 Group
Participants received a complete high-protein, high-calorie diet with mixed fiber.
Control (Standard treatment)
A complete high-protein and high-calorie diet with mixed fibre was administered.
Interventions
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Atémpero
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)
A complete high-protein and high-calorie diet with mixed fibre was administered.
Eligibility Criteria
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Inclusion Criteria
* Malnourished or at risk of malnutrition.
* Moderate-high risk of developing pressure-related injuries or the presence of pressure-related injuries.
Exclusion Criteria
* Contraindications for using the oral route and digestive intolerance or allergy to any of the components of the products.
ALL
No
Sponsors
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Vegenat Healthcare
UNKNOWN
Instituto de investigación e innovación biomédica de Cádiz
OTHER
University of Cadiz
OTHER
Responsible Party
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Antonio Jesús Marín Paz
Principal Investigator
Locations
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Punta Europa University of Cadiz
Algeciras, Cadiz, Spain
Countries
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References
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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.
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.
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.
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.
Roberts S, Chaboyer W, Desbrow B. Nutrition care-related practices and factors affecting nutritional intakes in hospital patients at risk of pressure ulcers. J Hum Nutr Diet. 2015 Aug;28(4):357-65. doi: 10.1111/jhn.12258. Epub 2014 Jun 27.
Eglseer D, Hodl M, Lohrmann C. Nutritional management of older hospitalised patients with pressure injuries. Int Wound J. 2019 Feb;16(1):226-232. doi: 10.1111/iwj.13016. Epub 2018 Nov 15.
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.
Langer G, Wan CS, Fink A, Schwingshackl L, Schoberer D. Nutritional interventions for preventing and treating pressure ulcers. Cochrane Database Syst Rev. 2024 Feb 12;2(2):CD003216. doi: 10.1002/14651858.CD003216.pub3.
Mervis JS, Phillips TJ. Pressure ulcers: Prevention and management. J Am Acad Dermatol. 2019 Oct;81(4):893-902. doi: 10.1016/j.jaad.2018.12.068. Epub 2019 Jan 18.
Banks MD, Ross LJ, Webster J, Mudge A, Stankiewicz M, Dwyer K, Coleman K, Campbell J. Pressure ulcer healing with an intensive nutrition intervention in an acute setting: a pilot randomised controlled trial. J Wound Care. 2016 Jul 2;25(7):384-92. doi: 10.12968/jowc.2016.25.7.384.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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84.21
Identifier Type: -
Identifier Source: org_study_id