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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013054
Receipt No. 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

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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
Email 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
Email sarusuke_papu22@yahoo.co.jp

Sponsor
Institute Department of Surgery, Saitama Medical Center, Jichi Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015230

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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