UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002658 |
|---|---|
| Receipt number | R000003235 |
| Scientific Title | Randomized-controlled trial comparing efficacy of new treatment using skin-wrapping sheet with conventional guideline-adhesion treatment for pressure sore |
| Date of disclosure of the study information | 2009/10/25 |
| Last modified on | 2011/01/05 14:56:23 |
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Basic information
Public title
Randomized-controlled trial comparing efficacy of new treatment using skin-wrapping sheet with conventional guideline-adhesion treatment for pressure sore
Acronym
skin-wrapping treatment vs conventional treatment for pressure sore
Scientific Title
Randomized-controlled trial comparing efficacy of new treatment using skin-wrapping sheet with conventional guideline-adhesion treatment for pressure sore
Scientific Title:Acronym
skin-wrapping treatment vs conventional treatment for pressure sore
Region
| Japan |
Condition
Condition
pressure ulcer
Classification by specialty
| Geriatrics | Surgery in general | Dermatology |
| Plastic surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare topical efficacy for pressure ulcers between treatment using skin-wrapping sheet and conventional guideline-adhesion treatment among adult patients with pressure ulcers categorized NPUAP II or III in their back
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
duration until complete healing of pressure ulcer
Key secondary outcomes
reduction of DESIGN-R score
reduction of PUSH score
ratio of healing of pressure ulcer within 6 months
cost-effectiveness
all death within observation period
change in nutritional status
adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
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
intervention group received "wrap therapy" which cover focused wound with polyethylene sheet. Use of any other ointment and devise recommended in conventional guidelines is allowed in intervention group
Interventions/Control_2
Conventional treatment that has an adhesion with "evidence-based clinical practice guidelines for pressure ulcer" 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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
. Admitted adults 50 years old or over who have one or more pressure ulcers in their back and hip
. body temperature 35.5-37.5
. those who intake 600kcal or more per day
. Serum albumin 2.0 or more
. serum creatinine below 2.0
. those who do not have liver cirrhosis, uncontrolled diabetes or malignancy
. those who are estimated that they require hospitalization in their observation period
. informed consent should be obtained
Key exclusion criteria
. those who are estimated that their prognosis is within 3 months clinically
. Those who have allergy history against dressing devices or ointments
. history of myocardial infarction or unstable angina within 6 months
. Those who are taking systemic steroids (predonisolone 10mg/d or more)
. those who with pressure sores that are difficult to be evaluated
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MIZUHARA, Akihito |
Organization
Higashi-Washinomiya Hospital
Division name
Department of Medicine
Zip code
Address
Sakurada 3-9-3, Washinomiya, Katsushika-gun, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HIRANO, Miki |
Organization
Higashi-Washinomiya Hospital
Division name
nursing department
Zip code
Address
TEL
0480-58-2468
Homepage URL
Sponsor or person
Institute
Higashi-Washinomiya Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 10 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 22 | Day |
Last modified on
| 2011 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003235
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
