Nutritional Support in Pressure Ulcer Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-11-30

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.

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Detailed Description

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Conditions

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Pressure Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Isonitrogenous isocaloric formula

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

Group Type ACTIVE_COMPARATOR

Control formula

Intervention Type DIETARY_SUPPLEMENT

Isonitrogenous isocaloric oral formula

Enriched nutrition formula

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

Group Type EXPERIMENTAL

Enriched nutrition formula

Intervention Type DIETARY_SUPPLEMENT

oral formula enriched in arginine, zinc and antioxidant oligoelements

Interventions

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Enriched nutrition formula

oral formula enriched in arginine, zinc and antioxidant oligoelements

Intervention Type DIETARY_SUPPLEMENT

Control formula

Isonitrogenous isocaloric oral formula

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cubitan (NUTRICIA Italia)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No