UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003322 |
|---|---|
| Receipt number | 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 10:47:46 |
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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
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
torunakamur@yahoo.co.jp
Sponsor or person
Institute
Teine Keijinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004032
