UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031560
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

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Basic information

Public title

A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection

Acronym

A randomized trial of efficacy of Olanexidine gluconate for surgical site infection

Scientific Title

A randomized trial of efficacy of Olanexidine gluconate versus Povidone iodine for surgical site infection

Scientific Title:Acronym

A randomized trial of efficacy of Olanexidine gluconate for surgical site infection

Region

Japan


Condition

Condition

Gastrointestinal surgery

Classification by specialty

Gastrointestinal surgery Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postoperative 30-day surgical site infection (SSI) rate

Key secondary outcomes

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.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

use of Olanexidine gluconate for surgical site before surgery

Interventions/Control_2

use of Povidone iodine for surgical site before 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

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.

Key exclusion criteria

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.

Target sample size

600


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 Shinano-machi Shinjuku-ku Tokyo, Japan

TEL

0353633802

Email

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 Shinano-machi Shinjuku-ku Tokyo, Japan

TEL

0353633802

Homepage URL


Email

masaty871222@gmail.com


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



Funding Source

Organization

This work was supported by donations from the Department of Surgery,
Keio University School of Medicine and Ohyama Health Foundation Inc.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University, Independent Ethics Committee

Address

35 Shinano-machi Shinjuku-ku Tokyo, Japan

Tel

0333531211

Email

med-rinri-jimu@adst.keio.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 05 Day


Related information

URL releasing protocol

https://www.sciencedirect.com/science/article/abs/pii/S1473309920302255

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/abs/pii/S1473309920302255

Number of participants that the trial has enrolled

597

Results

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.

Results date posted

2020 Year 10 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

Five patients (2%) in the olanexidine group and five (2%) in the povidone-iodine group developed adverse skin reactions.

Outcome measures

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).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 22 Day

Date of IRB

2018 Year 03 Month 16 Day

Anticipated trial start date

2018 Year 05 Month 01 Day

Last follow-up date

2019 Year 05 Month 19 Day

Date of closure to data entry

2019 Year 07 Month 31 Day

Date trial data considered complete

2019 Year 08 Month 01 Day

Date analysis concluded

2019 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 03 Day

Last modified on

2020 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036031


Research Plan
Registered date File name
2020/10/27 Local protocol final.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name