UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy of antibacterial suture for reducing the surgical site infection
Title of the study (Brief title)	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	Toshiki Rikiyama
Organization	Saitama Medical Center, Jichi Medical University
Division name	Department of Surgery
Address	1-847, Amanuma-cho, Omiya-Ku, Saitama
TEL	0486472111
Email	trikiyama@jichi.ac.jp

Public contact
Name of contact person	Kosuke Ichida
Organization	Saitama Medical Center, Jichi Medical University
Division name	Department of Surgery
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 09 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1016/j.surg.2017.12.020
Results
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/icdr_e/ctr_view.cgi?recptno=R000015230