Effect of nutritional intervention to prevention and treatment of pressure ulcer

UMIN ID: UMIN000002072

Registered date:13/06/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Pressure ulcer
• Date of first enrollment: 2007/07/01
• Target sample size: 120
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Nutritional intervention group
Control group

Outcome(s)

• Primary Outcome: Nutritional condition(i.anthropometric index, ii. clinical laboratory test results) Risks of developing pressure ulcer (OH scale, Bladen scale)
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Pressure Ulcer & WHR Center(Kojin-kai)
• Source(s) of Monetary Support: Comprehensive Research on Aging and Health(Ministry of Health , Labour and Welfare)