Clinical Trial: Nutritional Support in Pressure Ulcer Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nutritional Support in Malnourished Pressure Ulcer Patients: the Oligoelement Sore Trial (OEST)

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 Summary:
Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Current Primary Outcome: Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]

healing is defined as reduction in ulcer area (the percentage of change)


Original Primary Outcome: Rate of Healing [ Time Frame: 12 weeks ]

healing is defined as complete healing or reduction in ulcer area


Current Secondary Outcome:

  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    reduction in ulcer area >=40%
  • Rate of Healing [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    complete healing
  • Incidence of Infections [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    defined as local (ulcer)
  • Cost-effectiveness [ Time Frame: 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 [ Time Frame: 8 weeks of nutritional support (baseline and week 8) ]
    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) ]
    the reduction in ulcer area (%) observed at 4 weeks


Original Secondary Outcome:

  • reduction in costs of patient's care [ Time Frame: 12 weeks ]
  • Incidence of Infections [ Time Frame: 12 weeks ]
    defined as local (ulcer) or systemic


Information By: Azienda Ospedaliero Universitaria Maggiore della Carita

Dates:
Date Received: April 15, 2010
Date Started: February 2010
Date Completion:
Last Updated: January 16, 2014
Last Verified: January 2014