UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023417 |
|---|---|
| Receipt number | R000026979 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2024/02/23 06:56:17 |
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Basic information
Public title
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.
Acronym
A randomised, non-inferiority controlled trial to evaluate non-occlusive and non-adhesive dressing treatment for stage II pressure ulcers
Scientific Title
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.
Scientific Title:Acronym
A randomised, non-inferiority controlled trial to evaluate non-occlusive and non-adhesive dressing treatment for stage II 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, non-inferiority, controlled study is to establish the clinical efficacy of non-occlusive and non-adhesive dressing treatment using plastic wrap, polyethylene sheet, or non-adhesive dressing material compared with standard treatment conforming to guidelines for stage II pressure ulcers (international NPUAP/EPUAP pressure ulcer classification system) in adult patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
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 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.
Interventions/Control_2
Standard treatment conformed to treatment guideline published by National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. The wounds were treated with modern dressings including transparent film, hydrocolloid, and hydrocellular polyurethane dressing.
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 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.
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
330
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Taka |
Organization
Minakuchi Hospital
Division name
Department of Psychiatry
Zip code
528-031
Address
2-2-43, Honmachi, Minakuchi-cho, Koka
TEL
+81-748-62-1212
taka-jun@zd.ztv.ne.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Takahashi |
Organization
Minakuchi Hospital
Division name
Department of Psychiatry
Zip code
528-0031
Address
2-2-43, Honmachi, Minakuchi-cho, Koka
TEL
+81-748-62-1212
Homepage URL
mail@minakuchi-hp.or.jp
Sponsor or person
Institute
Minakuchi Hospital
Institute
Department
Personal name
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
Minakuchi Hospital Clinical Research Ethics Review Committee
Address
279 Nishitamazu-cho, Shimojuzuya-cho agaru, Ainomachidori Shimogyo section, Kyoto city
Tel
+81-75-344-6016
t.ando523@gmail.com
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 | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026979
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
