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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042605
Receipt No. R000048232
Scientific Title Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/30

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Basic information
Public title Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Acronym Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Scientific Title Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Scientific Title:Acronym Triclosan-coated sutures versus uncoated sutures for prevention of surgical site infection after abdominal wall closure in open/laparoscopic colorectal surgery
Region
Japan

Condition
Condition Surgical site infection
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of antimicrobial threads in fascial closure for colorectal surgery in relation to thread type and incidence surgical site infection
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of surgical site infection
Key secondary outcomes (1) Surgical site complications other than surgical site infection
(2) Post-operative hospital stay

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with scheduled colorectal cancer surgery
2) Patient has operable general condition and organ function.
3) Performance Status (ECOG) of either 0 or 1.
4) Written consent to participate in the study has been obtained from the patient.
Key exclusion criteria 1) There is no history of surgical wounds on the planned surgical site.
2) Do not perform surgery on other organs in different locations at the same time.
3) No history of radiation therapy or chemotherapy.
4) No contamination or infection surgery.
Target sample size 2200

Research contact person
Name of lead principal investigator
1st name Norikatsu
Middle name
Last name Miyoshi
Organization Osaka University, Graduate School of Medicine
Division name Departments of Gastroenterological surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Email nmiyoshi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Tsunekazu
Middle name
Last name Mizushima
Organization Osaka University, Graduate School of Medicine
Division name Departments of Gastroenterological surgery
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3251
Homepage URL
Email tmizushima@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization None
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 Osaka University, Graduate School of Medicine
Address 2-2 Yamadaoka, Suita, Osaka
Tel 06-6210-8290
Email jim-chiken@hp.crc.med.osaka-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
2020 Year 12 Month 01 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 2207
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 No longer recruiting
Date of protocol fixation
2016 Year 10 Month 04 Day
Date of IRB
2016 Year 10 Month 04 Day
Anticipated trial start date
2016 Year 10 Month 04 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Starting October 4, 2016, 2200 patients will be included in the study who will undergo standby colorectal surgery for patients aged 20 years and older with PS0-1. The sutures used for fascial sutures will be absorbable sutures selected by each institution.

Management information
Registered date
2020 Year 11 Month 30 Day
Last modified on
2020 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048232

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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