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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029211
Receipt No. R000032897
Scientific Title practical application of biomedical metal with photocatalyst
Date of disclosure of the study information 2017/09/25
Last modified on 2019/03/24

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Basic information
Public title practical application of biomedical metal with photocatalyst
Acronym practical application of biomedical metal with photocatalyst
Scientific Title practical application of biomedical metal with photocatalyst
Scientific Title:Acronym practical application of biomedical metal with photocatalyst
Region
Japan

Condition
Condition Conditions required treatment by external fixator
(deformity, limb discrepancy, fractures, osteomyelitis, and bone tumor of extremities)
Classification by specialty
Orthopedics Adult Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to investigate the effect of prevention of pin site infection by photocatalyst, which is the one of the most frequent complication in the treatment of external fixator.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes There are three points of assessment of infection; 1: local findings of pin site (effusion, pain, redness, and swelling), 2: blood chemical analysis, 3: X-ray images.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 <Intervention group>
Use of pin with photocatalyst in the treatment of external fixator
Interventions/Control_2 <Control group>
Use of pin without photocatalyst in the treatment of external fixator
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
3 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were scheduled for the operation by external fixators and whom informed consent have been obtained.
Key exclusion criteria Patient with allergy to titanium
Patient with infection at site of surgery
Patient with collagen disease or photosensitivity
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Oka
Middle name
Last name Yoshinobu
Organization Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Zip code 602-8566
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
TEL 075-251-5549
Email y-oka@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Oka
Middle name
Last name Yoshinobu
Organization Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medi
Division name Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medi
Zip code 602-8566
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
TEL 075-251-5549
Homepage URL
Email y-oka@koto.kpu-m.ac.jp

Sponsor
Institute Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural Medical University Medical Ethics Committee
Address Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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
2017 Year 09 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 Preinitiation
Date of protocol fixation
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 25 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 20 Day
Last modified on
2019 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032897

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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