Nutritional Support in Pressure Ulcer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Dietary Supplement: Enriched nutrition formula
* Dietary Supplement: Control formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient or legal guardian or caregiver consent stage II, III or IV pressure ulcers malnutrition (as defined by low body mass index and/or unintentional weight loss and/or low serum albumin and/or reduced food intake [<60% of total daily estimated requirements]) patients who can drink supplements home-care or long-term care Exclusion Criteria: decompensated diabetes (HbA1C >7%) renal failure hepatic failure (Child B and C) current neoplastic disease any organ-failure immunosuppressive therapy connective tissue disease use of steroids obesity respiratory insufficiency (COPD) anemia (haemoglobin <10g/dL) previous neoplastic disease (<1 year since last treatment CT or RT) infected wounds cellulitis, sepsis or osteomyelitis poor tolerance to sip feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isonitrogenous isocaloric formula<br>Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one | Dietary Supplement: Control formula<br>* Isonitrogenous isocaloric oral formula<br>|
| Experimental: Enriched nutrition formula<br>Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements | Dietary Supplement: Enriched nutrition formula<br>* oral formula enriched in arginine, zinc and antioxidant oligoelements<br>* Other names: Cubitan (NUTRICIA Italia);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcers, Healing, Malnutrition, Nutritional support, Micronutrients