UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029211 |
|---|---|
| Receipt number | R000032897 |
| Scientific Title | practical application of biomedical metal with photocatalyst |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2022/10/04 10:26:39 |
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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
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
y-oka@koto.kpu-m.ac.jp
Sponsor or person
Institute
Department of Orthopaedics, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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
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
no data
Publication of results
Unpublished
Result
URL related to results and publications
no data
Number of participants that the trial has enrolled
0
Results
no data
Results date posted
| 2022 | Year | 10 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
no data
Participant flow
no data
Adverse events
no data
Outcome measures
no data
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
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032897
