UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034535 |
|---|---|
| Receipt number | 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 | 2021/04/19 09:31:51 |
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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
y-stsh@pg8.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Koutaro |
| Middle name | |
| Last name | Takamatsu |
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
takamakt@gmail.com
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
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
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
2
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
| 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
| 2023 | 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
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037479
