UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040805 |
|---|---|
| Receipt number | R000046548 |
| Scientific Title | Chlorohexidine gluconate rubbing for prevention of wound infection: A randomized controlled trial. |
| Date of disclosure of the study information | 2020/06/20 |
| Last modified on | 2020/12/17 15:33:18 |
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Basic information
Public title
Chlorohexidine gluconate rubbing for prevention of wound infection: A randomized controlled trial.
Acronym
Chlorohexidine gluconate rubbing for prevention of wound infection: A randomized controlled trial.
Scientific Title
Chlorohexidine gluconate rubbing for prevention of wound infection: A randomized controlled trial.
Scientific Title:Acronym
SSI CHG rubbing study
Region
| Japan |
Condition
Condition
Surgical site infection
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of chlorhexidine gluconate rubbing to prevent wound infection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of wound infection during postoperative 30 days.
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
| Medicine |
Interventions/Control_1
Subcutaneous disinfection by Chlorohexidine gluconate rubbing.
Interventions/Control_2
Without subcutaneous disinfection.suturing
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
1.The age is older than 20 years of age.
2.Surgery for gastrointestinal, including emergency
3.The parson that a document agreement by the free was provided after enough understanding after having received enough explanation on participating to this study
Key exclusion criteria
1.Surgery with wound classification classI
2.Patients judged by investigators ineligible.
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugo |
Organization
Juntendo Nerima Hospital
Division name
Department of general surgery
Zip code
1778521
Address
3-1-10 Takanodai Nerima Tokyo
TEL
03-5923-3111
h.sugou@juntendo-nerima.jp
Public contact
Name of contact person
| 1st name | Shigefumi |
| Middle name | |
| Last name | Neshime |
Organization
Juntendo Nerima Hospital
Division name
Department of general surgery
Zip code
1778521
Address
3-1-10 Takanodai Nerima Tokyo
TEL
03-5923-3111
Homepage URL
s.neshime@juntendo-nerima.jp
Sponsor or person
Institute
Juntendo Nerima Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo Nerima Hospital
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
Juntendo Nerima Hospital GCP center
Address
3-1-10 Takanodai Nerima Tokyo
Tel
03-5923-3111
gcp@juntendo-nerima.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
| 2020 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2020 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046548
