N/A
N=200
Nutritional Support in Pressure Ulcer Patients
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01107197 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Rate of Healing — 62.9; 43.4 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enriched nutrition formula (Dietary_supplement); Control formula (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Healing |
12; 6 | — |
| SECONDARY Rate of Healing |
12; 6 | — |
| SECONDARY Rate of Healing |
12; 6 | — |
| SECONDARY Incidence of Infections |
9; 14 | — |
| SECONDARY Cost-effectiveness |
639; 689 | — |
| SECONDARY Dressings |
31; 35 | — |
| SECONDARY the Percentage of Change in Area |
29.3; 21.9 | — |
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.
Eligibility 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 [ 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
Data sourced from ClinicalTrials.gov (NCT01107197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.