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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002658
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Higashi-Washinomiya Hospital
Institute
Department

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
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

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
URL(English) https://upload.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
Registered date File name


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