Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers using plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment
Not Applicable
- Conditions
- pressure ulcer
- Registration Number
- JPRN-UMIN000023412
- Lead Sponsor
- Minakuchi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
Participants were excluded if their skin ulcer was due to other causes, including peripheral arterial occlusive disease, skin cancer; if they had poorly controlled diabetes (HbA1c > 10% measured at registration); or they were treated with corticosteroids, immunosuppressants, cytotoxic agents, or radiotherapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The absolute surface area reduction (SAR: baseline surface area - actual surface area). Whether the differences between the treatments will affect SAR for 12 weeks is investigated, and the SAR at 4, 8, and 12 week is compared for both treatments.
- Secondary Outcome Measures
Name Time Method PSST score reduction at 4, 8, and 12 week compared to baseline (baseline PSST score - actual PSST score). The incidence of adverse events including wound deterioration, local or systemic infection, hypergranulation, and maceration. Required time to treat. Required cost.