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

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 - Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023412

Enrollment

140

Registered

2016-08-01

Start date

2016-08-01

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

Stage III/IV pressure ulcers in the intervention group were treated with non-occlusive and non-adhesive dressing treatment using plastic wrap, polyethylene sheet, or non-adhesive dressing material. St

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 20 or older with stage III/IV pressure ulcers according to international NPUAP/EPUAP pressure ulcer classification system were included. Eligible participants had pressure ulcers measuring 4 cm2 to 80 cm2 (from 2 to 4 in the item of Size on the Pressure Sore Status Tool [PSST] ), and the ulcers were in the yellow inflammatory phase; at least 50% of the surface area was covered by necrotic tissue (from 4 to 5 in the item of Necrotic tissue amount on the PSST). If a patient had multiple pressure ulcers, the largest one was selected for this study. Written informed consent was obtained from participants or their family members.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactJun Takahashi

Minakuchi Hostpital Department of Psychiatry

mail@minakuchi-hp.or.jp+81-748-62-1212

Outcome results

None listed

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