Nutritional Support in Pressure Ulcer Patients

Azienda Ospedaliero Universitaria Maggiore della Carita200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Pressure Ulcers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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