Nutritional Support in Pressure Ulcer Patients
- Conditions
- Pressure Ulcers
- Interventions
- Dietary Supplement: Enriched nutrition formulaDietary Supplement: Control formula
- Registration Number
- NCT01107197
- Lead Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enriched nutrition formula Enriched nutrition formula Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements Isonitrogenous isocaloric formula Control formula Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
- Primary Outcome Measures
Name Time Method Rate of Healing 8 weeks of nutritional support (baseline and week 8) healing is defined as reduction in ulcer area (the percentage of change)
- Secondary Outcome Measures
Name Time Method Incidence of Infections 8 weeks of nutritional support (baseline and week 8) defined as local (ulcer)
Rate of Healing 8 weeks of nutritional support (baseline and week 8) complete healing
the Percentage of Change in Area 4 weeks of nutritional support (baseline and week 4) the reduction in ulcer area (%) observed at 4 weeks
Cost-effectiveness 8 weeks of nutritional support (baseline and week 8) 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).
Dressings 8 weeks of nutritional support (baseline and week 8) The number of dressings used throughout the intervention period
Trial Locations
- Locations (1)
Azienda Ospedaliero Universitaria Maggiore della Carita
🇮🇹Novara, Italy