Nutritional Support in Pressure Ulcer Patients (OEST)

University Hospital Maggiore della Carità of Novara

Status: Completed

Conditions: Pressure Ulcers

Treatments: Dietary Supplement: Control formula; Dietary Supplement: Enriched nutrition formula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01107197

473/CE (Study n° CE 61/07)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Isonitrogenous isocaloric formula

Active Comparator group

Description:

Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one

Treatment:

Dietary Supplement: Control formula

Enriched nutrition formula

Experimental group

Description:

Patients were given standard diet plus 2 bottles of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements

Treatment:

Dietary Supplement: Enriched nutrition formula