UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049712 |
|---|---|
| Receipt number | R000056625 |
| Scientific Title | Aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on the incidence of surgical site infections |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2024/03/05 22:20:55 |
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Basic information
Public title
Aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on the incidence of surgical site infections
Acronym
Oedo trial
Scientific Title
Aqueous olanexidine versus alcohol-based chlorhexidine for surgical skin antisepsis on the incidence of surgical site infections
Scientific Title:Acronym
Oedo trial
Region
| Japan |
Condition
Condition
Surgical site infection
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of 1.5% oranexidine gluconate disinfectant in reducing surgical site infection compared to 1% chlorhexidine gluconate alcohol disinfectant for Class II wound classification surgery in the gastrointestinal field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative 30-day surgical site infection rate
Key secondary outcomes
postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, positive bacterial wound culture rate, bacterial strain, intervention-related toxicity and allergic events rates, reoperation rate due to SSI, medical economic effect indicator, hospitalization duration.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
1.5% oranexidine gluconate disinfection group
Interventions/Control_2
1% Chlorhexidine gluconate alcohol antiseptic
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing standby general anesthesia surgery in the field of digestive organs (esophagus, stomach, duodenum, small intestine, colon, liver, biliary tract, pancreas) with wound classification Class II
2) Patients must be at least 18 years of age at the time of obtaining research consent.
3) Written consent to participate in the study has been obtained from the patient
Key exclusion criteria
1) Patients with a history of allergy to alcohol, including oranexidine gluconate or chlorhexidine gluconate alcohol
2) Patients who cannot be followed up for 30 days after surgery
3) Patients with active infection (except viral hepatitis)
4) Patients who have received antimicrobial agents the day before surgery
5) Emergency surgery and surgery requiring disinfection of mucous membrane surfaces and wound sites
6) Patients with a history of asthma
7) Other patients deemed by the physician to be unsuitable for the safe conduct of this study
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Obara |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
obara@z3.keio.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3802
Homepage URL
masaty871222@gmail.com
Sponsor or person
Institute
Keio University School
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma K.K.Johnson & Johnson
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Department of Surgery
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3802
masaty871222@gmail.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
| 2022 | Year | 12 | Month | 07 | 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
700
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
Our data-sharing policies are as follows: Individual participant data that underlie the results reported in this article will be available after deidentification (text, tables, figures, and appendices). The study protocol and statistical analysis plan will also be available to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. This type of analysis aims to achieve the goals of the approved proposal. Proposals should be directed to obara.z3@keio.jp. Data requestors must sign a data-access agreement to gain access. Data are available for 5 years on a third-party website.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056625
| 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 |
