UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043557 |
|---|---|
| Receipt number | R000049742 |
| Scientific Title | The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/08/09 09:28:57 |
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Basic information
Public title
The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Acronym
The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Scientific Title
The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Scientific Title:Acronym
The effect of surgical instrument exchange at closed wound on the Prevention of surgical site Infection in contaminated surgery of the lower gastrointestinal surgery
Region
| Japan |
Condition
Condition
lower gastrointestinal surgery
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to clarify the effect of instrument exchange at the time of wound closure on the prevention of wound infection in contaminated surgery of the lower gastrointestinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incisional surgical site infection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Changing surgical instrument at the time ofwound closure
Interventions/Control_2
not changing surgical instrument at the time ofwound closure
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
lower gastrointestinal surgery
Key exclusion criteria
laparoscopic surgery
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | hiroki |
| Middle name | |
| Last name | ikeuchi |
Organization
Hyogo college of medicine
Division name
gastointestinal surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6372
ikeuci2s@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kuwahara |
Organization
Hyogo college of medicine
Division name
gastointestinal surgery
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6372
Homepage URL
ri-kuwahara@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo college of medicine
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
Hyogo college of medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798456372
rinri@hyo-med.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
| 2021 | Year | 04 | 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
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
Main results already published
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2022 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049742
