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 | 2024/12/29 10:43:38 |
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
A Single-center, single-blind, randomized, parallel-group trial comparing Olanexidine Gluconate with Povidone Iodine during Inguinal Hernioplasty.
Japan |
Inguinal hernia
Surgery in general |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Incidence of surgical site infection within 90 days after surgery
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
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
Olanexidine gluconate is used for inguinal hernia surgery.
Povidone iodine is used for inguinal hernia surgery.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
660
1st name | Satoru |
Middle name | |
Last name | Nagatani |
Hiroshima City Funairi Citizens Hospital
Surgery
730-0844
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
082-232-6195
satorunagatani@gmail.com
1st name | Satoru |
Middle name | |
Last name | Nagatani |
Hiroshima City Funairi Citizens Hospital
Surgery
730-0844
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
082-232-6195
satorunagatani@gmail.com
Hiroshima City Funairi Citizens Hospital
None
Self funding
Hiroshima City Funairi Citizens Hospital, Ethics Committee
14-11 Funairisaiwaicho, Naka-ku, Hiroshima, Japan
082-232-6195
funairi-hosp@hcho.jp
NO
広島市立舟入市民病院(広島県)
2020 | Year | 06 | Month | 25 | Day |
Unpublished
Enrolling by invitation
2020 | Year | 06 | Month | 08 | Day |
2020 | Year | 06 | Month | 17 | Day |
2020 | Year | 06 | Month | 26 | Day |
2025 | Year | 12 | Month | 31 | Day |
2020 | Year | 06 | Month | 25 | Day |
2024 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046599