UMIN-CTR Clinical Trial

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
Email	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
Email	s.neshime@juntendo-nerima.jp

Sponsor
Institute	Juntendo Nerima Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046548