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Randomized-controlled trial comparing efficacy of new treatment using skin-wrapping sheet with conventional guideline-adhesion treatment for pressure sore

Randomized-controlled trial comparing efficacy of new treatment using skin-wrapping sheet with conventional guideline-adhesion treatment for pressure sore - skin-wrapping treatment vs conventional treatment for pressure sore

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002658
Enrollment
140
Registered
2009-10-25
Start date
2009-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pressure ulcer

Interventions

intervention group received &quot
wrap therapy&quot
which cover focused wound with polyethylene sheet. Use of any other ointment and devise recommended in conventional guidelines is allowed in intervention group Conventional treatment that has an adhe
evidence-based clinical practice guidelines for pressure ulcer&quot
issued by Japanese Society of Pressure Ulcers

Sponsors

Higashi-Washinomiya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: . Admitted adults 50 years old or over who have one or more pressure ulcers in their back and hip . body temperature 35.5-37.5 . those who intake 600kcal or more per day . Serum albumin 2.0 or more . serum creatinine below 2.0 . those who do not have liver cirrhosis, uncontrolled diabetes or malignancy . those who are estimated that they require hospitalization in their observation period . informed consent should be obtained

Exclusion criteria

Exclusion criteria: . those who are estimated that their prognosis is within 3 months clinically . Those who have allergy history against dressing devices or ointments . history of myocardial infarction or unstable angina within 6 months . Those who are taking systemic steroids (predonisolone 10mg/d or more) . those who with pressure sores that are difficult to be evaluated

Design outcomes

Primary

MeasureTime frame
duration until complete healing of pressure ulcer

Secondary

MeasureTime frame
reduction of DESIGN-R score reduction of PUSH score ratio of healing of pressure ulcer within 6 months cost-effectiveness all death within observation period change in nutritional status adverse events

Countries

Japan

Contacts

Public ContactHIRANO, Miki

Higashi-Washinomiya Hospital nursing department

0480-58-2468

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026