Unique ID issued by UMIN | UMIN000048691 |
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Receipt number | R000055481 |
Scientific Title | A randomized trial of efficacy of Olanexidine gluconate versus Chlorhexidine Gluconate for preventing surgical site infection - Phase II clinical trial - |
Date of disclosure of the study information | 2022/09/01 |
Last modified on | 2022/08/18 14:10:32 |
A randomized trial of efficacy of Olanexidine gluconate versus Chlorhexidine Gluconate for preventing surgical site infection - Phase II clinical trial -
A randomized trial of efficacy of Olanexidine gluconate for preventing surgical site infection
A randomized trial of efficacy of Olanexidine gluconate versus Chlorhexidine Gluconate for preventing surgical site infection - Phase II clinical trial -
A randomized trial of efficacy of Olanexidine gluconate for preventing surgical site infection
Japan |
Cardiovascular surgery, Digestive surgery
Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Cardiovascular surgery |
Others
NO
We conduct a randomized trial of efficacy of Olanexidine glucose versus Chlorhexidine Gluconate for SSI in cardiovascular surgery and gastrointestinal surgery
Efficacy
Exploratory
Pragmatic
Phase II
Postoperative 30-day surgical site infection (SSI) rate
Postoperative 30-day superficial incisional SSI rate, deep incisional SSI rate, organ/space SSI rate, rate of positive bacterial wound culture, and their strains, and toxicity and allergies events rate
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
Central registration
2
Prevention
Medicine |
Use of 1.5% Olanexidine gluconate for surgical site before surgery
Use of 1.0% Chlorhexidine gluconate for surgical site before surgery
18 | years-old | <= |
Not applicable |
Male and Female
Patients that satisfy all of the below requirements.
1)Surgery for cardiovascular surgery with sternotomy, or gastrointestinal surgery with laparotomy additionally wound classification class II or less.
2)The age is older than 18 years of age.
3)Having provided voluntary written consent for participation in this study.
Patients with any of the following cases are excluded.
1)Patients contraindicated for Olanexidine glucose or Chlorhexidine Gluconate
2)Follow- up failure due to pass-away or other reasons.
3)In case of urgent operation
4)Patients judged by investigators ineligible due to seriousness of patients condition.
200
1st name | Hiroshi |
Middle name | |
Last name | Yoshida |
Iwaki city medical center
Department of surgery
9738555
16 kusehara Uchigo mimayamachi Iwaki city, Fukushima prefecture, Japan
0246-26-3151
Kan-y@gc4.so-net.ne.jp
1st name | Yoshiki |
Middle name | |
Last name | Endo |
Iwaki city medical center
Department of cardiovascular surgery
9738555
16 kusehara Uchigo mimayamachi Iwaki city, Fukushima prefecture, Japan
0246-26-3151
yoshiki_endo@hotmail.com
Iwaki city medical center
Iwaki city medical center
Other
Iwaki city medical center
16 kusehara Uchigo mimayamachi Iwaki city, Fukushima prefecture, Japan
0246-26-3151
kyoritsu@iwaki-city-medical-center.jp
NO
2022 | Year | 09 | Month | 01 | Day |
Unpublished
Open public recruiting
2022 | Year | 08 | Month | 01 | Day |
2022 | Year | 08 | Month | 09 | Day |
2022 | Year | 08 | Month | 09 | Day |
2024 | Year | 04 | Month | 30 | Day |
2022 | Year | 08 | Month | 18 | Day |
2022 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055481
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