UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053380 |
|---|---|
| Receipt number | R000060920 |
| Scientific Title | Preventive effects for wound infection by the irrigation with povidone-iodine saline in patients undergoing gastrointestinal surgery: A randomized controlled study |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2024/01/17 22:03:12 |
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Basic information
Public title
Preventive effects for wound infection by the irrigation with povidone-iodine saline in patients undergoing gastrointestinal surgery: A randomized controlled study
Acronym
Preventive effects for wound infection by the irrigation with povidone-iodine saline
Scientific Title
Preventive effects for wound infection by the irrigation with povidone-iodine saline in patients undergoing gastrointestinal surgery: A randomized controlled study
Scientific Title:Acronym
Preventive effects for wound infection by the irrigation with povidone-iodine saline
Region
| Japan |
Condition
Condition
Patients undergoing open gastrointestinal surgery.
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test preventive effects for wound infection by povidone-iodine saline irrigation in patients undergoing open gastrointestinal surgery (control; irrigation by saline) through a randomized controlled study.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence rate of postoperative wound infection.
Key secondary outcomes
1. Detection of remnant bacteria in the wound after wound irrigation.
2. The association between the bacteria detected in the wound and those detected in preoperatively collected feces.
3. In case of wound infection, investigate the association between the bacteria detected in the wound infection, those detected in preoperatively collected feces, and those detected in the blood collected before surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Wound irrigation with povidone-iodine saline.
Interventions/Control_2
Wound irrigation by saline.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing open gastrointestinal surgery.
Key exclusion criteria
Patients who are allergic to iodine.
Patients who disagreed to participate in the study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sasaki |
Organization
Meijo Hospital
Division name
Department of Surgery
Zip code
460-0001
Address
1-3-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL
052-201-5311
e-sasaki@meijohosp.com
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442222
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Meijo Hospital
Institute
Department
Personal name
Eiji Sasaki
Funding Source
Organization
Meijo 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
Meijo Hospital Ethics Committee
Address
1-3-1 Sannomaru, Naka-ku, Nagoya, Aichi, Japan
Tel
0522015311
shinryojoho@meijohosp.com
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
| 2024 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 01 | Month | 17 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060920
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
