Skip to content

An evaluation of non-occlusive and non-adhesive dressing treatment in management for stage II pressure ulcers by plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment: a prospective, randomised, non-inferiority controlled trial.

An evaluation of non-occlusive and non-adhesive dressing treatment in management for stage II pressure ulcers by plastic wrap, polyethylene sheet, or non-adhesive dressing materials versus standard treatment: a prospective, randomised, non-inferiority controlled trial. - A randomised, non-inferiority controlled trial to evaluate non-occlusive and non-adhesive dressing treatment for stage II pressure ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023417
Enrollment
330
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 II 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. Standa

Sponsors

Minakuchi Hospital
Lead Sponsor
Minamikusatsu Keyaki Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 20 or older with stage II pressure ulcers according to international NPUAP/EPUAP pressure ulcer classification system were included. Eligible participants had pressure ulcers measuring 4 cm2 to 36 cm2 and the ulcers were in the red proliferation phase. 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

MeasureTime frame
Required period to heal the wound. Based on previous studies, the mean (standard deviation) was estimated as 3 weeks (3 weeks).Non-inferiority will be demonstrated within the margin of 1 week.

Secondary

MeasureTime frame
1)Comparison of survival curve using the period to heal the wounds. 2)The incidence of adverse events including wound deterioration, wound infection, hypergranulation, and maceration. 3)Required time to treat. 4)Required cost.

Countries

Japan

Contacts

Public ContactJun Takahashi

Minakuchi Hospital 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