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| Name | Class |
|---|---|
| Nutricia, Inc. | INDUSTRY |
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Pressure ulcers are frequently associated with malnutrition. Previous studies have reported that nutritional support can improve the healing rate of pressure ulcers but no attention has been clearly given to the nutritional status of the patient treated. Moreover, other investigators have suggested the additional healing power of some nutrients. Unfortunately, previous results have been unpowered by small sample size, poor monitoring of compliance to treatments and the confounding effect of other nutrients. The investigators aimed to test the effect and additional benefits of several micronutrients delivered through oral nutritional support on the healing rate of pressure ulcers in malnourished patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isonitrogenous isocaloric formula | Active Comparator | Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one |
|
| Enriched nutrition formula | Experimental | Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched nutrition formula | Dietary Supplement | oral formula enriched in arginine, zinc and antioxidant oligoelements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Healing | healing is defined as reduction in ulcer area (the percentage of change) | 8 weeks of nutritional support (baseline and week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Healing | reduction in ulcer area >=40% | 8 weeks of nutritional support (baseline and week 8) |
| Rate of Healing | complete healing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico D'Andrea, MD | Azienda Ospedaliero Universitaria Maggiore della Carita | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Maggiore della Carita | Novara | 28100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19563522 | Background | Cereda E, Gini A, Pedrolli C, Vanotti A. Disease-specific, versus standard, nutritional support for the treatment of pressure ulcers in institutionalized older adults: a randomized controlled trial. J Am Geriatr Soc. 2009 Aug;57(8):1395-402. doi: 10.1111/j.1532-5415.2009.02351.x. Epub 2009 Jun 25. | |
| 11431045 | Background |
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Participants: patients (long-term care residents or subjects at home care services) with stage 2, 3 or 4 pressure ulcer.
Estimated recruitment (sample size): 220 patients. Patients recruited and randomized to interventionas: 200 patients. The recruitment was stopped when at least 64 patients per treatment arm were available for analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Isonitrogenous Isocaloric Formula | Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks Control formula : Isonitrogenous isocaloric oral formula |
| FG001 | Enriched Nutrition Formula | Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Principal analysis were conducted according to the intention-to-treat (ITT) principle. ITT analyses were based on 157 patients. All patients who have been assessed at baseline and at least at 4 weeks will be included in the ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enriched Nutrition Formula | Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements |
| BG001 | Isonitrogenous Isocaloric Formula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Healing | healing is defined as reduction in ulcer area (the percentage of change) | Posted | Mean | Standard Deviation | percent change | 8 weeks of nutritional support (baseline and week 8) |
|
8 weeks of nutritional support
Direct observation of the patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enriched Nutrition Formula | Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements |
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Limited to specific settings: long-term care and home-care services Limited to malnourished patients
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Federico D'Andrea | Department of Clinical Nutrition and Dietetics, Azienda Ospedaliera "Maggiore della Carità" | +39 0321.373.3275 | dietologia@maggioreosp.novara.it |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009748 | Nutrition Disorders |
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| Control formula | Dietary Supplement | Isonitrogenous isocaloric oral formula |
|
| 8 weeks of nutritional support (baseline and week 8) |
| Incidence of Infections | defined as local (ulcer) | 8 weeks of nutritional support (baseline and week 8) |
| Cost-effectiveness | Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy). | 8 weeks of nutritional support (baseline and week 8) |
| Dressings | The number of dressings used throughout the intervention period | 8 weeks of nutritional support (baseline and week 8) |
| the Percentage of Change in Area | the reduction in ulcer area (%) observed at 4 weeks | 4 weeks of nutritional support (baseline and week 4) |
| Benati G, Delvecchio S, Cilla D, Pedone V. Impact on pressure ulcer healing of an arginine-enriched nutritional solution in patients with severe cognitive impairment. Arch Gerontol Geriatr Suppl. 2001;7:43-7. doi: 10.1016/s0167-4943(01)00120-0. No abstract available. |
| 15469215 | Background | Frias Soriano L, Lage Vazquez MA, Maristany CP, Xandri Graupera JM, Wouters-Wesseling W, Wagenaar L. The effectiveness of oral nutritional supplementation in the healing of pressure ulcers. J Wound Care. 2004 Sep;13(8):319-22. doi: 10.12968/jowc.2004.13.8.26654. |
| 18978686 | Background | Heyman H, Van De Looverbosch DE, Meijer EP, Schols JM. Benefits of an oral nutritional supplement on pressure ulcer healing in long-term care residents. J Wound Care. 2008 Nov;17(11):476-8, 480. doi: 10.12968/jowc.2008.17.11.31475. |
| 20598855 | Background | van Anholt RD, Sobotka L, Meijer EP, Heyman H, Groen HW, Topinkova E, van Leen M, Schols JM. Specific nutritional support accelerates pressure ulcer healing and reduces wound care intensity in non-malnourished patients. Nutrition. 2010 Sep;26(9):867-72. doi: 10.1016/j.nut.2010.05.009. Epub 2010 Jul 3. |
| 25643304 | Derived | Cereda E, Klersy C, Serioli M, Crespi A, D'Andrea F; OligoElement Sore Trial Study Group. A nutritional formula enriched with arginine, zinc, and antioxidants for the healing of pressure ulcers: a randomized trial. Ann Intern Med. 2015 Feb 3;162(3):167-74. doi: 10.7326/M14-0696. |
| Withdrawal by Subject |
|
Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one Control formula : Isonitrogenous isocaloric oral formula |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Rate of Healing | reduction in ulcer area >=40% | Posted | Number | participants | 8 weeks of nutritional support (baseline and week 8) |
|
|
|
| Secondary | Rate of Healing | complete healing | Posted | Number | participants | 8 weeks of nutritional support (baseline and week 8) |
|
|
|
| Secondary | Incidence of Infections | defined as local (ulcer) | Posted | Number | participants | 8 weeks of nutritional support (baseline and week 8) |
|
|
|
| Secondary | Cost-effectiveness | Incremental cost-effectiveness ratio (ICER) was calculated by dividing the difference between total costs (active - control) by the difference in the mean reduction (%) of ulcer area. Costs are derived from oral nutritional supplements, dressings, antibiotics, PU swab sampling, nurse visits for wound dressing (according to their duration and cost per hour), medical consultations (unitary cost of the visit for prescription of antibiotic therapy). | Posted | Mean | Standard Deviation | Euros | 8 weeks of nutritional support (baseline and week 8) |
|
|
|
| Secondary | Dressings | The number of dressings used throughout the intervention period | Posted | Mean | Standard Deviation | dressings | 8 weeks of nutritional support (baseline and week 8) |
|
|
|
| Secondary | the Percentage of Change in Area | the reduction in ulcer area (%) observed at 4 weeks | Posted | Median | Inter-Quartile Range | percent change | 4 weeks of nutritional support (baseline and week 4) |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Isonitrogenous Isocaloric Formula | Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one Control formula : Isonitrogenous isocaloric oral formula | 0 | 99 | 0 | 99 |
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| D009750 |
| Nutritional and Metabolic Diseases |