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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034535
Receipt No. R000037479
Scientific Title Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy
Date of disclosure of the study information 2018/10/18
Last modified on 2019/09/25

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Basic information
Public title Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy
Acronym pros and cons antibiotic prophylaxis in muscle biopsy
Scientific Title Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy
Scientific Title:Acronym pros and cons antibiotic prophylaxis in muscle biopsy
Region
Japan

Condition
Condition Patients with planning muscle biopsy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this randomized clinical trial was to investigate whether or not a single intravenous dose of cefazolin (1g) should be performed to prevent wound infection for immunocompetent patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence and proportion of wound infection after muscle biopsy
Key secondary outcomes 1) Background characteristics of patients
2) Adverse event of antibiotic
3) Wound score at the muscle biopsy performed region
4) characteristics of patients with wound infection
5) The relationship between days until the suture removal and the treatment with or without antibiotic
6) The relationship between body temperature and the treatment with or without antibiotic
7) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and the treatment with or without antibiotic
8) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and disease type, muscle biopsy performed region, operative duration of muscle biopsy and the value of manual muscle testing
9) The relationship between operative duration of muscle biopsy and disease type, muscle biopsy performed region, the value of manual muscle testing

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group with single-dose antibiotic prophylaxis of cefazolin (1g) at muscle biopsy.
Interventions/Control_2 The group without antibiotic prophylaxis at muscle biopsy
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Over 20 years old and less than 80 years old
2) Patient or proxy who can provide a informed consent
Key exclusion criteria 1) Patients who are not hospitalized in neurology
2) Less than 20 years old patients
3) Over 80 years old patients
4) Patients who are pregnant or might be pregnant
5) Immunocompromised patients
6) Patients with anamnesis of diabetes
7) Patients with over body mass index (BMI) of 25 kg/m2
8) Patients with experience of allergia for Cephalosporin antibiotic
9) Patients with anamnesis of anaphylactic shock for Cephalosporin
10) Patients with experience of hypersensitivity for local anesthetic such as anilide
11) Patients with over serum creatinine level 1.5 mg/dl
12) Patients with an infectious disease
13) Patient with treatment plan of immunosuppressive therapy immediately after muscle biopsy
14) Patients who have skin lesion at muscle biopsy planed region
15) Patients who are judged inappropriate for this trial by the attending physician
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Yamashita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Neurology
Zip code 860-8556
Address 1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL 096-373-5893
Email y-stsh@pg8.so-net.ne.jp

Public contact
Name of contact person
1st name Keiichi
Middle name
Last name Nakahara
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Neurology
Zip code 860-8556
Address 1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
TEL 096-373-5893
Homepage URL
Email 97056kn@gmail.com

Sponsor
Institute Kumamoto university
Institute
Department

Funding Source
Organization self-financing
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 Kumamoto University Hospital, Advanced medical care unit
Address 1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
Tel 096-373-5966
Email byi-senshin@jimu.kumamoto-u.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
2018 Year 10 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 27 Day
Date of IRB
2018 Year 09 Month 27 Day
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
2020 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
2018 Year 10 Month 17 Day
Last modified on
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037479

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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