UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036889 |
|---|---|
| Receipt number | 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 | 2023/01/22 10:04:00 |
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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
Single blind -participants 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
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
maemoto@jichi.ac.jp
Sponsor or person
Institute
Department of Surgery, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
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
s-suishin@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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
950
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
Yes
IPD sharing Plan description
Immediately after the publication of the primary results, de-identified individual participant data that underlie the results reported in the article(s) and other documents (study protocol and statistical analysis plan) will be available for any purpose, only if approved by the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Anyone who wishes to access the data should submit a proposal to maemoto@jichi.ac.jp. If approved, data requestors will need to sign a data access agreement. After that, the principal investigator will transfer the data and other documents to data requestors.
Progress
Recruitment status
Completed
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
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042037
