UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013054 |
|---|---|
| Receipt number | R000015230 |
| Scientific Title | Study of the efficacy of antibacterial suture for reducing the surgical site infection |
| Date of disclosure of the study information | 2014/03/01 |
| Last modified on | 2018/02/12 14:55:52 |
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Basic information
Public title
Study of the efficacy of antibacterial suture for reducing the surgical site infection
Acronym
Efficacy of antibacterial suture against the surgical site infection
Scientific Title
Study of the efficacy of antibacterial suture for reducing the surgical site infection
Scientific Title:Acronym
Efficacy of antibacterial suture against the surgical site infection
Region
| Japan |
Condition
Condition
Patients who undergo gastrointestinal operation
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of antibacterial suture for surgical site infection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperataive SSI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
antibacterial suture
Interventions/Control_2
non-antibacterial suture
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The case of digestive surgery
Key exclusion criteria
1 case with preoperative infection at surgical field
2 case with existence of stoma or drain preoperatively
3 case who undergo synchronous surgery
4 case with allergy for triclosan
5 case with pregnancy
6 case excluded by operator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Rikiyama |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
Address
1-847, Amanuma-cho, Omiya-Ku, Saitama
TEL
0486472111
trikiyama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Ichida |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Department of Surgery
Zip code
Address
1-847, Amanuma-cho, Omiya-Ku, Saitama
TEL
0486472111
Homepage URL
sarusuke_papu22@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Saitama Medical Center, Jichi Medical University
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
Address
Tel
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
| 2014 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.surg.2017.12.020
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
Main results already published
Date of protocol fixation
| 2013 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2018 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015230
