UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032897