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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024230
Receipt No. R000027899
Scientific Title Evaluation of effectiveness and safety of new pierced dressing material for post-operative wound and pressure ulcer
Date of disclosure of the study information 2016/10/03
Last modified on 2018/10/02

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Basic information
Public title Evaluation of effectiveness and safety of new pierced dressing material for post-operative wound and pressure ulcer
Acronym new pierced dressing material
Scientific Title Evaluation of effectiveness and safety of new pierced dressing material for post-operative wound and pressure ulcer
Scientific Title:Acronym new pierced dressing material
Region
Japan

Condition
Condition post-operative wound
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 effectiveness and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of the new dressing material
(check contact dermatitis and infection)
Key secondary outcomes Effectiveness of the new dressing material
(by evaluation of depth, exudation, size, infection, granulation, necrotic tissue and pocket)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 none
Interventions/Control_2
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 1) Patient: 20 years old<=
2) Post-operative wound or early pressure ulcer
3) Patients who agreed with this study by written informed consent
Key exclusion criteria 1) Patients who have allergy to the material
2) Others
3) Patients with infection
4) Patients with deep ulcer, such as necrotic tissue
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Shimizu
Organization Gunma University Hospital
Division name Department of Dermatology
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-8290
Email shimizuakira@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Shimizu
Organization Gunma University Hospital
Division name Department of Dermatology
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan.
TEL 027-220-8290
Homepage URL
Email shimizuakira@gunma-u.ac.jp

Sponsor
Institute Department of Dermatology
Gunma graduate school of medicine
Institute
Department

Funding Source
Organization Department of Dermatology
Gunma graduate school of medicine
Organization
Division
Category of Funding Organization Other
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
2016 Year 10 Month 03 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 09 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 30 Day
Last modified on
2018 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027899

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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