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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036889
Receipt No. R000042037
Scientific Title Effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterologic surgery: a double-blind, randomized controlled trial in a single center
Date of disclosure of the study information 2019/06/01
Last modified on 2019/06/01

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Basic information
Public title Effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterologic surgery: a double-blind, randomized controlled trial in a single center
Acronym Effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterologic surgery: a double-blind, randomized controlled trial in a single center
Scientific Title Effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterologic surgery: a double-blind, randomized controlled trial in a single center
Scientific Title:Acronym Effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterologic surgery: a double-blind, randomized controlled trial in a single center
Region
Japan

Condition
Condition Patients who undergo gastroenterologic surgery
Classification by specialty
Cardiology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of effect of irrigation with aqueous iodophor solution on the incidence of surgical site infection after abdominal wall closure in gastroenterological surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of surgical site infection after operation within 30 days
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Irrigation of the wound with 40 ml of 10% aqueous iodophor solution for one minute
Interventions/Control_2 Irrigation of the wound with 100 ml of saline for one minute
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 Patient who undergo gastroenterologic surgery
Key exclusion criteria The exclusion criteria are the identification of bacterial infection or use of antibiotic therapy prior to operation, presence of a contaminated abdominal cavity due to intestinal fistula or drainage tube, synchronous operation for more than 2 malignancies, open wound due to prior operation, pregnancy, known allergy to aqueous iodophor solution, and case who are judged as ineligible for inclusion.
Target sample size 950

Research contact person
Name of lead principal investigator
1st name Toshiki
Middle name
Last name Rikiyama
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Surgery
Zip code 330-8503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama
TEL 048-647-2111
Email trikiyama@jichi.ac.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Maemoto
Organization Saitama Medical Center, Jichi Medical University
Division name Department of Surgery
Zip code 330-8503
Address 1-847, Amanuma-cho, Omiya-ku, Saitama
TEL 048-647-2111
Homepage URL
Email maemoto@jichi.ac.jp

Sponsor
Institute Department of Surgery, Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization Department of Surgery, Saitama Medical Center, Jichi Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical Center, Jichi Medical University
Address 1-847, Amanuma-cho, Omiya-ku, Saitama
Tel 048-647-2111
Email inahara@jichi.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
2019 Year 06 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 Open public recruiting
Date of protocol fixation
2019 Year 04 Month 11 Day
Date of IRB
2019 Year 04 Month 11 Day
Anticipated trial start date
2019 Year 06 Month 01 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
2019 Year 05 Month 29 Day
Last modified on
2019 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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