pressure ulcer
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Minakuchi Hospital Department of Psychiatry