The effect of specialized nutritional intervention with a disease-specific sip feed (Cubitan) in the support of patients with pressure ulcers.
Completed
- Conditions
- Patients with stage III/IV pressure ulcers.
- Registration Number
- NL-OMON20924
- Lead Sponsor
- umico Research B.V.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Stage III or IV pressure ulcers according to the European Pressure Ulcer Advisory Panel (EPUAP) classification system;
2. Stage III or IV pressure ulcers located on sacrum, greater trochanter, ischium or heel;
Exclusion Criteria
1. Patients with severe medical conditions, e.g. ICU patients, patients with sepsis or serious infections, cancer patients requiring therapy, or patients after recent (< 3 months) myocardial infarction;
2. Patients with diabetes ulcers, ulcus cruris and/or vascular ulcer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of Cubitan added to standard institutional diet with non-caloric placebo added to standard institutional diet on pressure ulcer size during 8 weeks.
- Secondary Outcome Measures
Name Time Method To compare the effect of Cubitan added to standard institutional diet with non-caloric placebo added to standard institutional diet on pressure Ulcer Scale for Healing (PUSH) tool score and photographic assessment during 8 weeks (reflecting pressure ulcer size, exudate amount and tissue type).