Nutritional Support in Pressure Ulcer Patients (OEST)

This study has been completed.
Sponsor:
Collaborator:
NUTRICIA Italia
Information provided by (Responsible Party):
FEDERICO D'ANDREA, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier:
NCT01107197
First received: April 15, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Pressure Ulcers
Dietary Supplement: Enriched nutrition formula
Dietary Supplement: Control formula

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero Universitaria Maggiore della Carita:

Primary Outcome Measures:
  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    healing is defined as reduction in ulcer area (the percentage of change)


Secondary Outcome Measures:
  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    reduction in ulcer area >=40%

  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    complete healing

  • Incidence of Infections [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    defined as local (ulcer)

  • Cost-effectiveness [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ] [ Designated as safety issue: No ]
    The number of dressings used throughout the intervention period

  • the Percentage of Change in Area [ Time Frame: 4 weeks of nutritional support (baseline and week 4) ] [ Designated as safety issue: No ]
    the reduction in ulcer area (%) observed at 4 weeks


Enrollment: 200
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isonitrogenous isocaloric formula
Patients were given standard diet plus 2 bottles of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one
Dietary Supplement: Control formula
Isonitrogenous isocaloric oral formula
Experimental: Enriched nutrition formula
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
oral formula enriched in arginine, zinc and antioxidant oligoelements
Other Name: Cubitan (NUTRICIA Italia)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107197

Locations
Italy
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Italy, 28100
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita
NUTRICIA Italia
Investigators
Principal Investigator: Federico D'Andrea, MD Azienda Ospedaliero Universitaria Maggiore della Carita
  More Information

Publications:
Responsible Party: FEDERICO D'ANDREA, Director of Clinical Nutrition Unit, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT01107197     History of Changes
Other Study ID Numbers: 473/CE (Study n° CE 61/07)
Study First Received: April 15, 2010
Results First Received: March 10, 2013
Last Updated: January 16, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliero Universitaria Maggiore della Carita:
Pressure ulcers
Healing
Malnutrition
Nutritional support
Micronutrients

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014