UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014206
Receipt No. R000016541
Scientific Title Pin site infection in pediatric supracondylar humeral fractures. Daily pin care vs. no pin care
Date of disclosure of the study information 2014/06/08
Last modified on 2014/06/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pin site infection in pediatric supracondylar humeral fractures. Daily pin care vs. no pin care
Acronym Pin site infection in supracondylar humeral fractures
Scientific Title Pin site infection in pediatric supracondylar humeral fractures. Daily pin care vs. no pin care
Scientific Title:Acronym Pin site infection in supracondylar humeral fractures
Region
Asia(except Japan)

Condition
Condition Pediatric supracondylar humeral fractures
Classification by specialty
Pediatrics Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Skeletal immature patient
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Infection rate per patient
Key secondary outcomes Infection rate per pin

Base
Study type

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Pin site care by 75% alcohol daily
Interventions/Control_2 The pins and elbow were put in a cast. No pin site care
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
1 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria skeletal immaturity, a closed supracondylar humeral fracture treated by closed reduction and percutaneous K-wire fixation
Key exclusion criteria skeletal maturity, open fractures, fractures requiring open reduction or neurovascular exploration
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hsuan-Kai Kao
Organization Chang Gung Memorial Hospital
Division name Department of Pediatric Orthopedics
Zip code
Address 5, Fusing St., Gueishan Township, Taoyuan County 33305, Taiwan
TEL 886-3-3281200
Email samiyadondon@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hsuan-Kai Kao
Organization Chang Gung Memorial Hospital
Division name Department of Pediatric Orthopedics
Zip code
Address 5, Fusing St., Gueishan Township, Taoyuan County 33305, Taiwan
TEL 886-3-3281200
Homepage URL
Email samiyadondon@gmail.com

Sponsor
Institute Chang Gung Memorial Hpspital
Institute
Department

Funding Source
Organization Chang Gung Memorial Hpspital
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Taiwan

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 Department of Orthopedics, Chang Gung Memorial Hospital, Taoyuan, Taiwan
College of Medicine, Chang Gung University, Taoyuan, Taiwan

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 08 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 Terminated
Date of protocol fixation
2011 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2011 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
2014 Year 06 Month 08 Day
Last modified on
2014 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016541

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.