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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003322
Receipt No. R000004032
Scientific Title Triclosan Coated Sutures for the Reduction of Abdominal Wound Infections and Economic Considerations :Single institutional prospective randomized control trial
Date of disclosure of the study information 2010/03/12
Last modified on 2016/08/16

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Basic information
Public title Triclosan Coated Sutures for the Reduction of Abdominal Wound Infections and Economic Considerations :Single institutional prospective randomized control trial
Acronym Triclosan-Coated Sutures for the Reduction of Abdominal Wound Infections : Economic Considerations
Scientific Title Triclosan Coated Sutures for the Reduction of Abdominal Wound Infections and Economic Considerations :Single institutional prospective randomized control trial
Scientific Title:Acronym Triclosan-Coated Sutures for the Reduction of Abdominal Wound Infections : Economic Considerations
Region
Japan

Condition
Condition The patients who receive Colorectal surgery and Acute abdomen. (except appendicitis or upper gastrointestinal perforation)
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to ascertain if the use of triclosan-coated sutures reduced the number of wound infections and economic considerations after laparotomy comparing to non-coated sutures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes wound infection
Key secondary outcomes postoperative length of stay and their cost.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Interventions:Triclonsan-coated polyglactin suture materials with antibacterial activity(Vicryl plus) are used for close the wound after laparotomy.
Interventions/Control_2 Control:Polyglactin suture materials (Vicryl) are used for close the wound after laparotomy.
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 Patient who has the indication of operation
Key exclusion criteria Patient who needs second look operation after ICU treatment.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuichi Kashimura
Organization Teine Keijinkai Hospital
Division name Department of Surgery
Zip code
Address 1-12, Maeda, Teine-ku, Sapporo, 006-8555, Japan
TEL 011-681-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toru Nakamura
Organization Teine Keijinkai Hospital
Division name Department of Surgery
Zip code
Address 1-12, Maeda, Teine-ku, Sapporo, 006-8555, Japan
TEL 011-681-8111
Homepage URL
Email torunakamur@yahoo.co.jp

Sponsor
Institute Teine Keijinkai Hospital
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
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 手稲渓仁会病院

Other administrative information
Date of disclosure of the study information
2010 Year 03 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
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 Completed
Date of protocol fixation
2009 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 03 Month 12 Day
Last modified on
2016 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004032

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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