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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008139
Receipt No. R000009587
Scientific Title The effect of liquid film-forming dressing for skin preparation of central venous catheter insertion site on preventing blood borne infection in patients undergoing chemotherapy or hematopoietic stem cell transplant
Date of disclosure of the study information 2012/06/11
Last modified on 2015/04/27

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Basic information
Public title The effect of liquid film-forming dressing for skin preparation of central venous catheter insertion site on preventing blood borne infection in patients undergoing chemotherapy or hematopoietic stem cell transplant
Acronym Prevention of blood borne infection using liquid film-forming dressing
Scientific Title The effect of liquid film-forming dressing for skin preparation of central venous catheter insertion site on preventing blood borne infection in patients undergoing chemotherapy or hematopoietic stem cell transplant
Scientific Title:Acronym Prevention of blood borne infection using liquid film-forming dressing
Region
Japan

Condition
Condition Hematological Malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of liquid film-forming dressing on preventing blood borne infection in patients undergoing chemotherapy or hematological stem cell transplant for hematological malignancies by preventing skin trouble caused by conventional tape barrier device.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The occurrence of central venous catheter related blood bourne infection
Key secondary outcomes The occurence of skin trouble of CVC insertion site, its timing and degree

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 Prevention
Type of intervention
Other
Interventions/Control_1 The additional use of non-alcohol skin preparation as liquid film-forming dressing at the time of dressing change of CVC insertion site
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients treated for hematological malignancy with either chemothrapy or hematopoietic stem cell transplant at Keio University Hospital and require CVC insertion.
Key exclusion criteria Patients who did not consent to be included in the study.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakiko Kondo
Organization Keio University Hospital
Division name Nursing Department
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0333531211
Email sakiko.kondo@adst.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chie Yasutomi
Organization Keio University Hospital
Division name Nursing Department
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 0333531211
Homepage URL
Email yasutomichieis@hotmail.co.jp

Sponsor
Institute Keio University Hospital Nursing Department
Institute
Department

Funding Source
Organization Novartis Pharma.
Organization
Division
Category of Funding Organization Profit 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
2012 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2012 Year 06 Month 11 Day
Last modified on
2015 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009587

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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