Unique ID issued by UMIN | UMIN000031560 |
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Receipt number | R000036031 |
Scientific Title | A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection |
Date of disclosure of the study information | 2018/03/05 |
Last modified on | 2020/10/27 15:50:44 |
A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection
A randomized trial of efficacy of Olanexidine gluconate for surgical site infection
A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection
A randomized trial of efficacy of Olanexidine gluconate for surgical site infection
Japan |
Gastrointestinal surgery
Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Malignancy
NO
We conduct a randomized trial of efficacy of Olanexidine gluconate versus povidone Iodine for SSI in gastrointestinal surgery, such as gastrectomy, esophagectomy, hepatectomy and pancreaticoduodenectomy.
Efficacy
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 (erythema, symptoms of allergy) rate.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
2
Prevention
Medicine |
use of Olanexidine gluconate for surgical site before surgery
use of Povidone iodine for surgical site before surgery
20 | years-old | <= |
Not applicable |
Male and Female
Patients that satisfy all of the below requirements.
1) Surgery for gastrointestinal, such as gastrectomy, esophagectomy, hepatectomy and pancreaticoduodenectomy with wound classification classII
2)The age is older than 20 years of age.
3) Having provided voluntary written consent for participation in this study.
1)Patients contraindicated for Olanexidine gluconate or Povidone iodine
2) Follow-up failure due to pass-away or other reasons.
3) Patients who have active infectious disease.
4)Patients who were prescribed antibiotics day before surgery.
5)Urgent surgery or surgery with sterilization to the mucosal surface or wound.
6)Patients judged by investigators ineligible due to seriousness of patients condition.
600
1st name | Hideaki |
Middle name | |
Last name | Obara |
Keio University, School of Medicine
Department of Surgery
160-8582
35 Shinano-machi Shinjuku-ku Tokyo, Japan
0353633802
obara.z3@keio.jp
1st name | Masashi |
Middle name | |
Last name | Takeuchi |
Keio University, School of Medicine
Department of Surgery
160-8582
35 Shinano-machi Shinjuku-ku Tokyo, Japan
0353633802
masaty871222@gmail.com
Keio University
This work was supported by donations from the Department of Surgery,
Keio University School of Medicine and Ohyama Health Foundation Inc.
Other
Keio University, Independent Ethics Committee
35 Shinano-machi Shinjuku-ku Tokyo, Japan
0333531211
med-rinri-jimu@adst.keio.ac.jp
NO
2018 | Year | 03 | Month | 05 | Day |
https://www.sciencedirect.com/science/article/abs/pii/S1473309920302255
Published
https://www.sciencedirect.com/science/article/abs/pii/S1473309920302255
597
Between June 10, 2018, and April 18, 2019, 883 patients were assessed for eligibility. 587 patients were eligible and 294 received olanexidine and 293 received aqueous povidone-iodine before surgery. 30-day SSI occurred in 19 (7%) patients in the olanexidine group and 39 patients (13%) patients in the povidone-iodine group.
2020 | Year | 10 | Month | 27 | Day |
Patients aged 20 years or older who underwent elective clean-contaminated wound surgery were randomly assigned in a 1:1 replacement ratio using a computer-generated block randomisation.
Patients were randomly assigned to surgical skin antisepsis with an aqueous formulation of 1.5% olanexidine or surgical skin antisepsis with an aqueous formulation of 10% povidone-iodine before surgery.
Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions.
The primary outcome was 30-day SSI after surgery based on the criteria in the US Centers for Disease Control and Prevention guidelines.22 Secondary outcomes assessed were the occurrence of superficial incisional SSI, deep incisional SSI, and organ-space SSI, positive wound bacterial test rate and bacterial strains, and interventionrelated toxicity and allergic events (eg, erythema, pruritus, dermatitis, or symptoms of allergy around the region disinfected by the antiseptic during surgery).
Completed
2017 | Year | 12 | Month | 22 | Day |
2018 | Year | 03 | Month | 16 | Day |
2018 | Year | 05 | Month | 01 | Day |
2019 | Year | 05 | Month | 19 | Day |
2019 | Year | 07 | Month | 31 | Day |
2019 | Year | 08 | Month | 01 | Day |
2019 | Year | 08 | Month | 31 | Day |
2018 | Year | 03 | Month | 03 | Day |
2020 | Year | 10 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036031
Research Plan | |
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2020/10/27 | Local protocol final.docx |
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