UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023412
Receipt No. R000026973
Scientific Title 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
Date of disclosure of the study information 2016/08/01
Last modified on 2020/03/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title 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
Acronym Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers
Scientific Title 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
Scientific Title:Acronym Randomized controlled trial to evaluate non-occlusive and non-adhesive dressing treatment in management for stage III/IV pressure ulcers
Region
Japan

Condition
Condition pressure ulcer
Classification by specialty
Surgery in general Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized controlled study is to compare the efficacy of non-occlusive and non-adhesive dressing treatment using plastic wrap, polyethylene sheet, or non-adhesive dressing material versus standard treatment conforming to guidelines for stage III/IV pressure ulcers (international NPUAP/EPUAP pressure ulcer classification system) in adult patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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.
Key secondary outcomes 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.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 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.
Interventions/Control_2 Standard treatment conformed to treatment guideline published by NPUAP/EPUAP/PPPIA, and Japanese guideline issued by Japanese Society of Pressure Ulcers.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Takahashi
Organization Minakuchi Hospital
Division name Department of Psychiatry
Zip code
Address 2-2-43, Honmachi, Minakuchi-cho, Koka
TEL +81-748-62-1212
Email taka-jun@mx.scn.tv

Public contact
Name of contact person
1st name
Middle name
Last name Jun Takahashi
Organization Minakuchi Hostpital
Division name Department of Psychiatry
Zip code
Address 2-2-43, Honmachi, Minakuchi-cho, Koka
TEL +81-748-62-1212
Homepage URL
Email mail@minakuchi-hp.or.jp

Sponsor
Institute Minakuchi Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Minamikusatsu Keyaki Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 一般社団法人水口病院(滋賀県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 07 Month 07 Day
Date of IRB
2016 Year 07 Month 22 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 31 Day
Last modified on
2020 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.