UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014206 |
|---|---|
| Receipt number | 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 16:02:03 |
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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
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
samiyadondon@gmail.com
Sponsor or person
Institute
Chang Gung Memorial Hpspital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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