UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053133 |
|---|---|
| Receipt number | R000060009 |
| Scientific Title | The Role of Antibiotics to Prevent Infection in Fingertip Injury that Treated by Debridement and Simple Defect Closure |
| Date of disclosure of the study information | 2023/12/25 |
| Last modified on | 2023/12/17 15:17:11 |
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Basic information
Public title
The Role of Antibiotics to Prevent Infection in Fingertip Injury that Treated by Debridement and Simple Defect Closure
Acronym
Antibiotics to prevent infection in fingertip injuries
Scientific Title
The Role of Antibiotics to Prevent Infection in Fingertip Injury that Treated by Debridement and Simple Defect Closure
Scientific Title:Acronym
Antibiotics to prevent infection in fingertip injuries
Region
| Asia(except Japan) |
Condition
Condition
Patients with fingertip injuries that will undergo debridement and simple defect closure
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The goal of study is to assess the differences of infection rate between subgroups with administration of antibiotics and without antibiotic in FTI treated by debridement and simple defect closure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The intervention group was given with antibiotics: intravenous ceftriaxone for prophylactic antibiotic, and cefixime for postoperative oral regimen.
Interventions/Control_2
The control group received placebo
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient has fingertip injury Allen classification I to IV
The patient undergo debridement and defect closure using local anesthesia
The wound is mildly contaminated
Key exclusion criteria
The patient has another wound or other conditions that require antibiotic administration
The patient has consumed antibiotic before admission
The patient has allergy to cefriaxone and cefixime
The patient suffers from type 2 diabetes
The patient suffers from autoimmune disease
The patient regularly consumed immunosuppressant
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Wahyu |
| Middle name | |
| Last name | Widodo |
Organization
Universitas Indonesia
Division name
Orthopaedics and Traumatology
Zip code
10430
Address
Jl. Pangeran Diponegoro No. 71, Central Jakarta
TEL
1500135
wawidfkui@yahoo.com
Public contact
Name of contact person
| 1st name | Nesta |
| Middle name | |
| Last name | Enggra |
Organization
Universitas Indonesia
Division name
Orthopaedics and Traumatology
Zip code
10430
Address
Jl. Pangeran Diponegoro No. 71, Central Jakarta
TEL
1500135
Homepage URL
nesteanggra@gmail.com
Sponsor or person
Institute
Universitas Indonesia
Institute
Department
Personal name
Nesta Enggra
Funding Source
Organization
Universitas Indonesia
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
Universitas Indonesia
Address
Jl. Salemba 6, Central Jakarta
Tel
+6221213157008
ec_fkui@yahoo.com
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
Universitas Indonesia (Jakarta, Indonesia)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | 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
32
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060009
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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