UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040892 |
|---|---|
| Receipt number | R000046599 |
| Scientific Title | A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty. |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2022/04/01 11:27:27 |
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Basic information
Public title
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
Acronym
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
Scientific Title
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
Scientific Title:Acronym
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
Region
| Japan |
Condition
Condition
Inguinal hernia
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of oranexidine gluconate with povidone iodine during inguinal hernioplasty, and to verify that the incidence of surgical site infection is significantly reduced in the group using oranexidine gluconate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of surgical site infection within 90 days after surgery
Key secondary outcomes
1. Postoperative hospital stay
2. Outpatient revisit rate
3. Readmission rate
4. The incidence of postoperative hematoma
5. The incidence of surgical treatment for wounds
6. The incidence of all complications
7. Operative mortality
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Olanexidine gluconate is used for inguinal hernia surgery.
Interventions/Control_2
Povidone iodine is used for inguinal hernia surgery.
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. Patients who are 20 years or older at the time of obtaining consent.
2. Performance Status (PS) is 0-1 of Eastern Cooperative Oncology Group (ECOG).
3. Patients whose function of main organ is maintained.
A)WBC is 2,500 /mm3 or over.
B)Hb is 8.0 g/dL or over.
C)Plt is 75,000 /mm3 or over.
D)T-Bil is 2.0 mg/dL or less.
E)Cre is 3.0 mg/dL or less.
4. Patients who have sufficient judgment to understand the content of the study and who have obtained informed consent to participate in this study.
Key exclusion criteria
1. Patients with severe ischemic heart disease (NYHA class III or higher).
2. Patients with liver cirrhosis or active hepatitis (liver damage C).
3. Patients with respiratory distress who need oxygen administration due to interstitial pneumonia or pulmonary fibrosis.
4. Patients undergoing dialysis due to chronic renal failure.
5. Patients with active cancer who are thought to affect adverse events.
6. Patients with allergies to beta-lactam antibiotics.
7. Patients who are allergic to olanexidine gluconate or povidone iodine.
8. Patients infected with planned skin incision.
9. Patients with psychosis or psychiatric symptoms who are considered difficult to participate in this study.
10. Patients who did not obtain consent to participate in this study.
11. Patients who are deemed inappropriate for conducting this study by the investigator.
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Nagatani |
Organization
Hiroshima City Funairi Citizens Hospital
Division name
Surgery
Zip code
730-0844
Address
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
TEL
082-232-6195
satorunagatani@gmail.com
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Nagatani |
Organization
Hiroshima City Funairi Citizens Hospital
Division name
Surgery
Zip code
730-0844
Address
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
TEL
082-232-6195
Homepage URL
satorunagatani@gmail.com
Sponsor or person
Institute
Hiroshima City Funairi Citizens Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Hiroshima City Funairi Citizens Hospital, Ethics Committee
Address
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
Tel
082-232-6195
funairi-hosp@hcho.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
広島市立舟入市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 25 | 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 | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 07 | 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 | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046599
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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