Pressure ulcer
Conditions
Interventions
Nutritional intervention group
Control group
Sponsors
Pressure Ulcer & WHR Center(Kojin-kai)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Alb: 2.5 to 3.5g/dL OH scale: less than 8.5 Bladen scale: 9 to 17 Inpatients with more than 12 weeks of objective energy intake by tube feeding Patients without dehydration Pressure ulcer cases: Region of pressure ulcer must be sacrum, coccyx, greater trochanter, and heal. Stage must be 3 or 4(NPUAP) Area of necrosis tissues must be less than 20% of area of pressure ulcer The depth of pocket of pressure ulcer must be less than 2 cm
Exclusion criteria
Exclusion criteria: Patients with ileus or no residual intestinal function Patients with not using gastrointestinal tract more than 30 days Patients with laboratory value of AST or ALT is over 2.5 times of criteria in each hospitals HbA1c:more than 8.0% Cre:more than 2.0mg/dL Urinary protein on qualitative analysis:more than 2+ Patients with ASO Patients with a history of hypersensitivity or allergy to dressing, ointment, and enteral formula Patients with cancer or a history of cancer within 5 years Pressure ulcer cases: Patients with more than 2 stage 2 to 4(NPUAP) pressure ulcer or wound infection Patients who determine inappropriate to enroll clinical study by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nutritional condition(i.anthropometric index, ii. clinical laboratory test results) Risks of developing pressure ulcer (OH scale, Bladen scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time courses of change in serum iron, cupper and zinc Time courses of change in morbid bony preminence on sacrum Time courses of change in edema | — |
Countries
Japan
Outcome results
None listed