UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003874 |
|---|---|
| Receipt number | R000004661 |
| Scientific Title | Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial |
| Date of disclosure of the study information | 2010/07/12 |
| Last modified on | 2012/01/06 09:56:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial
Acronym
Study of the efficacy of antibacterial suture for surgical site infection
Scientific Title
Study of the efficacy of antibacterial suture for surgical site infection: a retrospective controlled trial
Scientific Title:Acronym
Study of the efficacy of antibacterial suture for surgical site infection
Region
| Japan |
Condition
Condition
The case of digestive surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively investigate triclosan-coated sutures for the closure of abdominal incision decrease surgical site infection compared with absorbable surgical suture Coated VICRYL.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of surgical site infection
Key secondary outcomes
Hospital stay after surgery
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
Over twenty years old
The case of gastroenterological surgery include emergency
Key exclusion criteria
The case who assessed as inadequasy
Target sample size
645
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Yamashita |
Organization
Fukuoka University School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
7-45-1,Nanakuma, Jonan-ku,Fukuoka
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichiro Hoshino |
Organization
Fukuoka University School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
7-45-1,Nanakuma, Jonan-ku,Fukuoka
TEL
092-801-1011
Homepage URL
shoshino@fukuoka-u.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery,
Fukuoka University School of Medicine
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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 12 | 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
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
Preinitiation
Date of protocol fixation
| 2010 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The incidence of surgical site infection
Hospital stay after surgery
Management information
Registered date
| 2010 | Year | 07 | Month | 06 | Day |
Last modified on
| 2012 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004661
