UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002550 |
|---|---|
| Receipt number | R000003117 |
| Scientific Title | A randomized controlled trial of preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture |
| Date of disclosure of the study information | 2009/10/01 |
| Last modified on | 2019/10/02 14:54:08 |
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Basic information
Public title
A randomized controlled trial of preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture
Acronym
A randomized controlled trial of preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture
Scientific Title
A randomized controlled trial of preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture
Scientific Title:Acronym
A randomized controlled trial of preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture
Region
| Japan |
Condition
Condition
gastrointestinal neoplasm
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate preventative effect on wound complication after gastrointestinal surgery by coated antibacterial suture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
wound complication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
absorbable suture with an antimicrobial coating
Interventions/Control_2
absorbable suture without an antimicrobial coating
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
Resection for esophageal, gastric, or colorectal cancer
Key exclusion criteria
1. Emergency
2. Suppuration wound
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Miyashiro |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Surgery
Zip code
5378511
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN
TEL
06-6972-1181
miyashir@biken.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Miyashiro |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Surgery
Zip code
5378511
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN
TEL
06-6972-1181
Homepage URL
miyashir@biken.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Foundation for the Prevention of Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN
Tel
06-6972-1181
mitui-ku@mc.pref.osaka.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
| 2009 | Year | 10 | 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
75
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 | 07 | Month | 21 | Day |
Date of IRB
| 2009 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 26 | Day |
Last modified on
| 2019 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003117
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
